# Patent

## Title
Method and article of manufacture for performing clinical trial budget analysis

## Abstract

A computer-implemented method is provided of analyzing budgets for clinical trials. A clinical trial budget is entered into a processor. The budget includes activities and associated activity costs. The activities are classified into a set of standardized service categories. The processor then allocates the associated activity costs with the respective standardized service category. The budget further includes assumption specifications. The processor further calculates per unit costs of the assumption specifications. The activities and the associated activity costs are then equalized against reference assumption specifications using at least the per unit costs.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Application No. 60/939,059 filed May 19, 2007 entitled “Clinical Trial Budget Analysis.”


BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to the analysis of clinical trial budgets. More particularly, this invention relates to a computer-implemented method for analyzing budgets for clinical trials.
2. Background
The life sciences industry includes pharmaceutical and biotechnology companies that are required to perform various phases of clinical trials (also referred to as clinical studies) on new drugs, compounds and medical devices before they can obtain marketing approval from the U.S. Food and Drug Administration or a foreign counterpart. Clinical trials are expensive to conduct and require effective budgeting processes in order to keep costs under control and obtain the best return on investment. The budgeting process for conducting a clinical trial is complex since is often requires the pharmaceutical or biotechnology company, known as the “sponsor” of the trial, to use many different vendor suppliers in addition to its own resources. The process used to select between potential vendor suppliers can profoundly affect a sponsor's clinical trial budget since vendor suppliers can price the same services in significantly different ways and amounts, and the budgeting processes currently used by sponsors cannot identify these pricing differences without significant time and expense as is described below in greater detail.
FIG. 1 illustrates the following example of the flow of budget information into a biotechnology company, which is not intended to be limiting in any way. Several different lists of activities and associated costs (LOAACS) shown on FIG. 1 contain many itemized activities and costs that are proposed in order to complete a clinical trial under a set of specification assumptions. According to an embodiment of the invention, this set of specification assumptions include number of sites, number of patients, number of countries, and the like, that are estimated to be necessary to complete a specific clinical trial. A vendor supplier (a Contract Research Organization or CRO for this example) or an in-house team is given a set of assumption specifications with a list of requested activities by the biotechnology company in the form of a document called a “Request for Proposal” (RFP). The RFP sets forth the specification assumptions and the list of requested activities from which a responder must prepare a budget containing the costs for the activities under the specification assumptions. CROs respond to an RFP in their own standard format and send a number of standard and non-standard documents to the biotechnology company, which is then responsible for analysis of the budget information to properly cost and then perform a clinical trial.
A “budget” as described herein, may be an internal project budget or a bid for outsourced work.
Although the biotechnology company carefully designs the RFP and the CROs or in-house teams might carefully prepare the RFP responses, it is very difficult and time consuming to analyze the budgets provided. This happens because of many different reasons: many activities are necessary to conduct a trial including teleconferences, training, meeting time, and the like; there is no standard terminology; there are no standard categorizations for these activities. For example, one person preparing a budget might use the term “teleconference” for a training session because that is the way the training is conducted, while another person reserves the term “teleconference” for weekly meetings conducted on the telephone. To further add to the confusion, the categories for these activities are not standardized. For example, one person analyzing a budget might classify the “teleconference-training” activity under the category “initial study set up,” while another person will categorize the same activity under the category of “monitoring” because the training is being done for the monitors who will monitor the trial. As there are hundreds of activities and multiple categories, confusion and misunderstandings can quickly multiply.
Similar budget process problems can and do occur within a pharmaceutical company or other companies in the life sciences industry. While this example shows the flow of information in the industry to obtain budget proposals from vendor suppliers such as Contract Research Organizations (CROs), a similar process is used to formulate budgets for other types of vendor suppliers and for in-house resources. Again, a similar process is used if a combination of in-house and vendor resources are used.
In order to try to reduce the confusion, some biotechnology and pharmaceutical companies write detailed RFPs, which provide standard categories and standard terms for activities. Persons who prepare budgets are asked to provide detailed information for the budget within the RFP. A goal of this is to make the analysis process simpler, so that the budgets can be compared, contrasted, and costs understood easily if there is a change in any of the assumption specifications. However, completing and comparing budgets within an RFP has not solved the problem. The reasons that confusion and errors still exist are due to many factors including the following factors:

    
    
        1. No benchmark libraries of standard terms, costs, categories, activities are easily available.
        2. There are few staff that have the detailed financial and operational expertise to do a proper analysis.
        3. There are little or no performance metrics linked to cost metrics.
        4. Teams and supplier vendors may unintentionally or purposefully leave gaps in the lists of activities needed to complete a clinical trial.
        5. Supplier vendors are unable to conform their internal costing, pricing and budgeting to the many different RFPs that their clients expect them to complete.
    
    


Unfortunately, the result of the confusion surrounding the analysis of budgets is that the biotechnology companies and others managing the budgets cannot, for example, make accurate pricing comparisons or compile accurate budgets. These mistakes cause a biotechnology company to pay more than is necessary for some activities. Another problem is that budget overruns are high due to gaps in activities that have not been budgeted. In addition, with the lack of proper budget analysis, the clinical trial often suffers from poor performance, delays and failure.
SUMMARY OF THE INVENTION
The present invention overcomes the drawbacks of the prior art through a computer-implemented method of analyzing budgets for clinical trials. In one embodiment of the present invention, a person analyzing a budget for a clinical trial may accept the budget in any format, using any common terminology in the industry and any common categorization. The present invention may accept this information, process it through a series of steps, and produce reports that make the analysis simple and accurate. There is no limitation to the reports that can be produced by the present invention, and several examples are provided below. In one embodiment, the present invention organizes and analyzes the budgets using libraries of benchmark metrics for costs, terminology, categorization, and the like. Algorithms may take into account the complexity of the clinical trials, the therapeutic area (e.g., cardiology, neurology, and the like). Furthermore, the information can be analyzed according to phases of clinical development, adaptive trials, and the like, that are done in any country around the globe.
The present invention also provides a biotechnology company with an analysis, reports and recommendations for selecting a clinical research organization to conduct a clinical trial. Pharmaceutical and biotechnology companies can also attain an “apples to apples comparison” of budget options and supplier options.
The present invention may be used to assists companies that perform clinical trials in understanding what may be the most efficient and cost-effective way for running a given trial—whether it be using internal resources, or outsourcing, or a combination of both.
In one preferred embodiment, the present invention inputs one or more clinical trial budgets into a processor. The budget may include activities such as monitoring activities, data management activities, and biostatistical activities, and the like, that are conducted during clinical trials. The budgets may also include prices and costs associated with these activities. Costs can be analyzed in dollars, pounds, or any other currency.
In an embodiment of the present invention, reports are produced that compare and reference assumptions and their associated costs. These referenced assumptions may be contained in libraries of benchmarking information on cost metrics, service metrics, performance metrics, time to perform activities, standard terminology for activities, staffing rates, and the like. The reports may include a series of financial and operational analyses showing where the discrepancies are within any submitted vendor/supplier budgets or proposals, or within client's internal or resource plan.



BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
In the drawings:
FIG. 1 shows an example of the flow of budget information into a biotechnology company for a clinical trial.
FIG. 2 shows a sample of reports provided in accordance with preferred embodiments of the present invention.
FIG. 3 is a flow diagram of the entire process that is performed by one preferred embodiment of the present invention.
FIG. 4 illustrates a standardization process according to one preferred embodiment of the present invention.
FIGS. 5A-5G, taken together, show the calculation of monitoring visits based on time (frequency of visits) according to a reference specification assumption in accordance with one preferred embodiment of the present invention.
FIG. 6 illustrates a normalization process according to one preferred embodiment of the present invention.
FIG. 7 illustrates an equalization process according to one preferred embodiment of the present invention.
FIG. 8 is a flowchart of a process used to create a business analysis according to one preferred embodiment of the present invention.
FIGS. 9A-9P, taken together, is a request for proposal (RFP) provided by a biotechnology company.
FIGS. 10A-10B, taken together, show a response sent back to the biotechnology company by a particular Clinical Research Organization (CRO) in response to the RFP.
FIG. 11A-FIG. 11U shows the RFP response that was given to the biotechnology company by a CRO.
FIGS. 12A-12P, taken together, show a list of activities and associated costs that were given to the same biotechnology company by a different CRO
FIGS. 13A-13EEE, taken together, show three sets of CRO responses.
FIG. 14 shows an excerpt from a CRO proposal that highlights a discrepancy in their proposal.
FIG. 15 shows a spreadsheet that relates to the discrepancy highlighted in FIG. 14.
FIGS. 16A-16B and 17-19 show spreadsheets related to RFP services.
FIGS. 20-21, 22A-22B and 23 show summary reports related to RFP's.
FIG. 24 is a hardware configuration diagram in accordance with one preferred embodiment of the present invention.
FIGS. 25A1-25G2, taken together, list algorithms and formulas used to calculate and produce reports.
FIG. 26 shows a summary report of a business analysis case study performed in accordance with a preferred embodiment of the present invention.
FIGS. 27-36 show a sample financial report associated with the business analysis case study.



DETAILED DESCRIPTION OF THE INVENTION
For purposes of explaining the present invention, specific embodiments will be described. These embodiments are exemplary only, and are not intended to limit the scope of the invention.
FIG. 2 shows a sample of reports provided by the present invention and demonstrates what the reports provide compared to the current process of analysis. Providing an easy way for companies to analyze budgets for conducting clinical trials has proven to play a large part in saving time and money, has taken the risk out of the clinical trial process, and has reduced the length of time needed to conduct a clinical trial.
FIG. 3 is a flow diagram of the entire process that is performed by an embodiment of the invention. This process occurs by inputting clinical trial budget information into a processor, including assumption specifications, activities and associated costs. As seen in FIG. 3, the data flow is as follows according to an embodiment of the invention: when the budget and information—LOAACs (Lists of Activities and Associated Costs), RFP, RFP responses, and any accompanying material that is part of the process are received, shown in A, they are inputted into the processor, shown in B. The many different ways for imputing such information into a processor are well known to those skilled in the art, including through a user interface, downloading from the web, importing an electronic files, scanning, and the like. In an example selected to illustrate an embodiment of the invention, FIGS. 9A-9P, taken together, is an RFP provided by a biotechnology company. As can be seen from this example, these RFPs are very detailed and exacting as to how the Biotechnology Company wants to see the responses returned. The RFP contains information about the trial. FIG. 9A shows the information about the trial protocol, such as the indication and objectives. FIG. 9B shows the timelines (dates). FIG. 9C-9F lists all of the assumption specifications. The RFP also provides a very specific structure for the activities and the cost of the activities as seen in FIG. 9G-9P. In the illustrated example, there five proposals were sent in against the RFP and three were used in this example. Lists of Activities and Associated Costs (LOAACS) are often sent instead of, or in conjunction with, the RFP response. FIG. 10A-10B shows the LOAACs (consisting of just two summary pages) that were sent back to the biotechnology company by Clinical Research Organization number 2 (CRO2) in response to the request for a proposal to conduct a specific clinical trial. FIG. 11A-FIG. 11U shows the RFP response that was given to the biotechnology company by CRO2 that were sent with the LOAACs. FIG. 11E line 1.1 shows how CRO2 has filled in one of the boxes on the RFP with dollar amounts, units, and the like.
FIGS. 12A-12P, taken together, show the LOAACs that were given to the same biotechnology company by a different Clinical Research Organization (CRO4) in response to the same request for a proposal to conduct the same clinical trial. The LOAACs from CRO4 contain much detailed information, which one would think would help the biotechnology company make a decision, however, it just makes the analysis and comparison more difficult. To add to the confusion, CRO4 provided a lot more information than requested and added other types of information that were not requested. For example, FIGS. 12A-12D show columns for the activities and assumption specifications for a ‘one month follow-up’, a ‘six month follow-up’, and a ‘one year follow-up’. This information is entirely different than any of the CROs provided. FIGS. 12E-12P show the activities and costs, but do not exactly match the assumptions on the prior figure. Extra information, although it might seem to be useful, is often confusing and difficult to analyze and compare with other information. FIGS. 13A-13EEE, taken together, show three sets of CRO4 RFP responses, namely, FIGS. 13A-13S, FIGS. 13T-13LL, and FIGS. 13MM-13EEE. These sets of figures show three different RFP responses that correspond to the proposed ‘one month follow-up’, ‘six month follow-up’, and ‘one year follow-up’ scenarios proposed by CRO4. The most confusing aspect of these three responses is that, as can be seen on FIG. 13A, FIG. 13T and FIG. 13MM, the line for ‘follow up period’ shows as 6 months. However on FIG. 13E, the costs for item 1. Project Management is $140,499. This is the cost associated with the 6 months assumption specification shown on FIG. 13A. Yet in FIG. 13X, the costs for item 1. Project Management is $144,399. This cost is for the 6 months assumption specification shown on FIG. 13T. Yet again, FIG. 13QQ shows that the costs for item 1. Project Management is $148,149. This cost is for the 6 months assumption specification shown on FIG. 13MM. Preferred embodiments of the present invention identify such discrepancies.
The trial sponsor did not specifically request this information, but often a CRO includes other options and budgets from those requested. It is important to note that one of the important problems that the current embodiment of the invention solves, is that a non-clinical member of the biotechnology team has clinical data about the trial that is translated into understandable financial information to make a better decision. The clinical member of the team also gets financial information translated into clinical information, so it is easy for them to understand. This type of invention solves the problem that it is rare and costly to find clinical resources with financial backgrounds and financial resources with clinical problems.
Only two CROs are discussed in this example used to illustrate one of several possible embodiments of the invention. However, there is no limit to the amount or size of information that the present invention can analyze.
Standardization Process
Standardization is the process of classifying the activities into a set of standardized service categories. FIG. 4 illustrates the standardization process according to an embodiment of the invention, which can be done automatically, by the processor. This can be an important process because all of the accompanying materials received may be preferably reconciled and crosschecked, and discrepancies may be preferably logged into the libraries of benchmark metrics. The standardization process may preferably identify discrepancies within the materials (RFP response, LOAACs) sent to the biotechnology company. This may be done in an essentially “blinded” way so that bias is removed in the process. The LOAAC's description of services are crosschecked against the unit of activities, checked against the metric (assumption specification) in the RFP and the protocol and checked mathematically for accuracy in calculations of units and costs. The services that are named in the LOAACs are checked against the benchmark libraries of terminology. The next step identifies the activities that are named differently on each LOAAC, yet are actually the same activity. An electronic translator automatically performs some or all of the classification. The electronic translator includes a dictionary of activities and their associated standardized service categories so that it can then categorize all the services named on the LOAACs into standard categorizes, for comparison.
According to an embodiment of the invention, the process of inputting the clinical trial budget information into the processor may preferably include the cataloging, inventorying, and assembly of all materials that have been received, and then adding them to the libraries of benchmark metrics. The budget includes activities and associated costs.
An example of a discrepancy is illustrated in FIG. 14, which is an excerpt of the information sent to a biotechnology company by CRO. Besides the RFP response and the LOAACs, CRO, has included additional information in paragraph form, as seen in this FIG. 14. In paragraph C, the underlined sentence explains that CRO1 will provide the monitoring visit activities every six weeks. This is discrepant with what CRO has shown in their LOAACs related to monitoring visits on FIG. 15. On line 5.2.1, CRO1 is budgeting for 453 visits. These two pieces of information are contradictions, but not easy to spot, because they are in different forms. This embodiment of the invention will identify and display the discrepancies, as well as the correct number of monitoring visits needed for a clinical trial that has a specification assumption of 36 months for the trial timeline, and a specification assumption for frequency of monitoring visits at every six weeks. The correct number of monitoring visits would be 3,900 visits. The gap in the activity of monitoring visits is 3,447. This calculation is embedded in FIG. 5F in the line item called “Interim visits—paper CRFs” in row 36, with the formula shown in far right of column I.
FIGS. 5A-5G, taken together, show the calculation of monitoring visits based on time (frequency of visits) according to the reference specification assumptions (e.g., RFP from sponsor).
This embodiment of the invention discovers these errors without needing trained project staff and finance experts to dig deeply into three different documents and cross-reference all calculations, costs, activities and assumption specifications. Some of these steps in the process may be done simultaneously or, depending on the situation, skipped entirely, according to an embodiment of the invention.
According to an embodiment of the invention, FIG. 4 includes the steps that the processor makes in order to classify the activities into a set of standardized service categories such as “data management,” “project management,” “safety,” and the processor allocating the associated activity costs with the respective standardized service category. An electronic translator can be used that references dictionaries of terms within the processor to match activities to the nearest similar term.
According to an embodiment of the invention, details regarding the units and costs for the trial's specification assumptions, as shown in a screen shot in FIGS. 16A and 16B, specification assumptions are inputted during the standardization process. FIG. 16A shows the first 40 lines and FIG. 16B shows the rest. The input may reflect the specification assumptions from the request for proposal from the biotechnology company, in this example. This step is done to generate within an embodiment of the invention, the benchmark specification assumptions and costs in standard categories of professional fees, as seen in FIG. 17 for CRO2 and in FIG. 18 for CRO4. The processor calculates the standardized activities together with their associated costs, based on the specification assumptions from the LOAACs from CRO2 and CRO4. The standardized items and their dollar amounts per standardized category are then generated according to an embodiment of the invention as shown in FIG. 19. This standardization process may include services and costs that are associated with the activities, sorted into the same standard categories. This may all be done based on libraries of activities terminology, libraries of category terminology, and libraries of cost and pricing methods that are used to compare and find common terms and categories, and the like. There is no limit to the libraries, and provisions can be made for continuous update of all libraries of benchmark metrics and algorithms used.
According to an embodiment of the invention, the standardization process may preferably complete crosschecks. These crosschecks may preferably compare each LOAAC against the RFP for a specific trial. Activities may be identified that are the same in meaning but are named differently in each LOAAC. At the end of this step, the new, standardized LOAACs may display all of the activities and the corresponding units and costs metrics itemized for CRO2 and CRO4. There is no limitation to the number of CROs, the activities listed, the costs, and the like, that can be processed by this embodiment of the invention. A result of this standardization process is that all of the activities may be in the same format, using naming terminology that is now common to CRO2 and CRO4. All costs may be listed under commonly named categories, enabling accurate comparison of specification assumptions and costs.
Normalization Process
According to an embodiment of the invention, the next step in FIG. 3 is the normalization process that provides per unit costs, to compare the activities and associated activity costs to reference assumptions. The processor can calculate per unit costs of the assumptions specifications. The preferable components of this step are illustrated in FIG. 6. A clinical trial will have assumption specifications (e.g., number of patients, number of sites, number of months to complete enrollment, total number of months for the trial, number of countries). One or more of the assumption specifications are input into the processor, which then calculates per unit costs of the assumption specifications.
According to an embodiment of the invention, this step crosschecks each LOAAC assumption specification against reference assumptions—e.g., the RFP, another iteration of a budget. Discrepancies are then preferably highlighted and deltas reported (differences between the RFP and LOAACs, for example). In addition, the normalization process may crosscheck each LOAAC unit with the unit costs, and identify discrepancies and report the deltas of the level of services. The normalization process may also crosscheck each LOAAC description of services against the units proposed to identify discrepancies and report the deltas in costs.
According to an embodiment of the invention, the normalization process then performs the following: (1) check on the feasibility of the units of activities and the costs against benchmark metrics for trials of similar size, scope, and therapeutic area; (2) reconcile all totals of units and financials —check the entire math, now that everything is standardized, calculate; and (3) display the costs and numbers of activities into units such as “cost per patient,” “cost per site,” “cost per page,” “cost per month,” and “cost per monitoring visit.” This discloses that if CRO2 adds sites, for example, it will cost ‘X’ per site. If the trial requires more monitoring visits, the amount this will cost with each CRO, based on the LOAACs, becomes known.
According to an embodiment of the invention, the normalization report may preferably classify costs and numbers of activities into buckets such as “cost per patient,” “cost per site,” “cost per page,” “cost per month,” and “cost per monitoring visit.” This can be an important guideline for watching for overruns and points for further discussion. This report may also point out differences in monitoring intervals.
According to an embodiment of the invention, the normalization process may preferably compare the total cost for the sum of activities listed in the standardized LOAACs, standard categories, for CRO2 and CRO4. A comparison may be made of the total cost budgeted for each standard category listed in the standardized LOAACs. The normalization process then preferably calculates the per unit costs so that a biotechnology company will have immediate information on the changes in the budgets that will occur based on any change in the number of units. The units are changed often in clinical trials, and a biotechnology company is usually unable to understand the resultant budget change because so many activities and associated costs are affected by a change in the trial.
Equalization Process
According to an embodiment of the invention, the next step is the equalization process referenced in FIG. 3E, which equalizes the activities and the associated activity costs against reference assumption specifications (e.g., benchmark metrics, RFP, one of the CRO LOAACs), using at least the per unit costs. The preferable components of this step are illustrated in FIG. 7. The equalization process may preferably equalize the activities and the associated activity costs (LOAACs specification assumptions and costs) against reference assumption specifications, using at least the per unit costs. These reference specifications can be the RFP or benchmark specification assumptions for a trial of the same scope and therapeutic area. This step allows an accurate comparison between CRO2 and CRO4. An embodiment of the invention also provides more accurate information about the total budget because gaps in services have been identified and added to the total, as appropriate. An embodiment of the invention also has the ability to provide budget information under different budget scenarios. For example, both CRO2 and CRO4 can be equalized to any specification assumptions. A value of this capability is that reports may be provided that are preferably adjusted for other specification assumptions without having to request new cost information from CRO2 and CRO4, which can save weeks on the process.
According to an embodiment of the invention, the equalization process may preferably compare the total units and cost of each activity and category for CRO2 and CRO4 against each other. The equalization process may also compare CRO2 against benchmark metrics, as well as CRO4 against benchmark metrics. Assessment is made in an embodiment of the invention to check that activity is within the range of industry norms. The equalization process may then identify additionally required activities that may be missing in the CRO2 and CRO4 LOAACs. The cost for these additionally required activities plus the corresponding totals can then be calculated and displayed in the reports. This protects biotechnology and other companies from budget overruns later in a trial, when the surprising extra cost can adversely affect the stability of the company.
Summarizing this step of the process according to an embodiment of the invention, the activities and the associated activity costs are preferably “equalized” against reference assumptions such as benchmark metrics, using the per unit costs. These per unit costs may then be used by an embodiment of the invention to automatically compare the activities and the associated costs with the reference specifications.
In addition, according to an embodiment of the invention, normalization and equalization can be used without standardization. For example, the clinical trial budget, including assumption specifications and associated activity costs, could be analyzed by input into the process either by data entry or in an electronic format. Per unit costs of the assumption specifications are calculated by the processor, and the activities and associated costs are compared against reference assumption specifications using the per unit costs. This equalization is done if there are missing activities, or activities that are under-budgeted. The equalization evens out the budgets for comparison, such as when one budget has different factors from another budget. This may include, for example, differences in length of trial.
Reporting Process
According to an embodiment of the invention, reports that may provide information about the analysis of the budgets and comparisons of budgets are generated automatically. With the completion of each step of the process, reports may be generated based on algorithms that can preferably compare and contrast the specification assumptions and costs. Algorithms may be preferably combined with information from LOAACs to produce reports that present information that may not otherwise be attainable without significant time and expense.
Many algorithms and mathematical formulas are used during the process. Examples of these algorithms are shown in the accompanying application. There are libraries of algorithms and all formulas are enhanced as new information is added related to industry pricing, costing, and other metrics. There is no limit to the number of algorithms that the processor uses to perform the functions.
According to an embodiment of the invention, it is not necessary for a biotechnology company to have received budgets, responses to RFPs, and LOAACs in order to perform an analysis of the budget needs for a clinical trial. FIG. 8 illustrates the direction the process takes if LOAACs are available, or when the biotechnology company wishes to use an embodiment of the invention to determine which suppliers and budgets or specifications might be appropriate for its protocol. FIG. 8 illustrates the process when the biotechnology company has available LOAACS and when it does not.
FIGS. 20, 21, 22 and 23 show examples of reports that may be produced by preferred embodiments of the present invention.
FIG. 20 is a summary of supplier differences report and analysis. The report of findings is blinded on the List Of Activities and Associated Costs to remove bias (no CRO name is included). This information is summarized for the first time. All have advantages and disadvantages, but the key is to understand these advantages and disadvantages. Scope differences, missing items, and errors in the budgets are the reason for the major discrepancy between the suppliers.
FIG. 20 report A shows a side-by-side comparison of CRO2 and CRO4 assumption specifications compared to the RFP. This report is extremely helpful to a biotech company because it highlights the assumptions that are not detailed and highlights the differences. In report A of FIG. 20, Key Variances are important deltas of differences between the RFP and LOAACs. “Not detailed” means that there is a dollar amount and some discussion of the work, but no exact specifications. This report provides information that highlights that there were no exact number of edit checks to be done, iterations of them, changes, or unit prices found by the processor in CRO2's LOAAC. There was just a dollar amount for the main activity of data management. There is no dollar amount associated with the activity, nor is there any discussion or activities mentioned in the LOAACs. ‘Yes’—means activity is included, as per the costs, yet there is no number of units/specifications for the item.
Classifying costs into equivalent categories in order to enable comparability forms standardized professional fees shown in Report B of FIG. 20. The subtotal shows a huge difference in cost. The report also highlights that the costs are not inclusive. The questions that this report answers are helpful to a biotechnology company in understanding if they are getting a really good value at that low price, a really bad job, or if there is simply a misunderstanding or error about the assumptions specifications.
Report C in FIG. 20 shows adjustments to equalize specifications. The algorithms have calculations that add what is missing, and include necessary work as requested by the RFP. This section adds the activities to correct the budgets, and add the cost of activities that CROs do not include, because the work is very difficult to perform cost effectively. These activities include integrating all the information into a single, analyzable database, and the reconciliations of the data once everything is together. Reports D and E in FIG. 20 are different alternative sets of specification assumptions to run this clinical trial. These reports illustrate how the invention can quickly display the cost that would be charged by either of the CROs, if the assumption specifications were adjusted.
FIG. 21 shows the detail of differences in metrics (specification assumptions for CRO 2 and CRO 4 and as stated in the RFP. The first table in this report standardizes specifications into major categories as seen in column one: Overall Assumptions, Project Management Assumptions, Monitoring Assumptions, Data Management Assumptions, Biostats Assumptions, and Safety. These are the categories of activities that are necessary to complete the trial. This standardization and categorization sorts all supplier items into common terms so that you can compare the specifications more accurately.
The number of items, and a note where items are ‘not detailed’ are shown in the column for any supplier. These columns let you quickly see what is not included, or not detailed within the LOAACs. These items that are not mentioned by the supplier may be important to the trial and will be discussed more fully with them. Other items are not included in the budget, but will be needed for the trial, are listed as well. The last column in this table shows the RFP specifications.
FIG. 22-A provides a report on the financial comparison, showing the dollar amounts for CRO2 and CRO4. FIG. 22-B shows other expenses and their totals lined up side-by-side in the standardized categories. With these reports, a biotech can see how the dollars compare for the standard categories. Once the differences are identified, further analysis of the activities, the cost of the activities, and the assumption specifications is performed and the results are displayed in a report that details normalized costs. The normalized costs identifies that the difference in cost is because there is a very specific difference in a specific assumption specifications. FIG. 23 shows a report that details the normalized comparator information, taken directly from the LOAACs. This report classifies costs and numbers of activities into buckets such as ‘fees (costs) per patient’, ‘cost per site’, ‘cost per page’, ‘cost per month’, and ‘cost per monitoring visit’. This is an important guideline for watching for overruns, and points for further discussion. This report also points out differences in monitoring intervals and the like.
It is not clear in supplier proposals that one supplier is actually providing a lower cost project than the other. For example, looking at the fee per site, fee per patient, and fee per month (normalized) one supplier may appear higher or lower, but this may not actually be true. Monitoring visit metrics might not detail the hours per visit; therefore a complete comparison cannot be made.
FIG. 24 is a hardware configuration diagram for the current embodiment of the invention.
FIGS. 25A1-25G2, taken together, list the algorithms and the formulas used by the processor to calculate and produce all of the information in the reports and the formatted reports as well. These formulas and algorithms allow the processor to accept input and calculate and display standardized comparisons of the CRO LOAACs or RFP responses with the reference specifications (e.g., benchmark metrics and benchmarking metrics). Reference activities and costs are also calculated and displayed for analysis and comparisons for costs and assumption specification references. The preferred embodiment of the present invention also provides the assumptions specifications and the costs, both normalized and equalized. FIG. 25A is illustrated in two parts, FIGS. 25-A1 and 25-A2, indicating that this figure is larger than the page.
According to an embodiment of the invention, the content of a complete generated report may comprises one or more of the following:

    Clinical Operations information
    
        1. Risk management analysis
        2. Responsibilities clearly delineated
    
    
    Data Consolidation
    
        1. Integration control charts
        2. Reporting controls
        3. Performance metric tracking
        4. Replacement of faulty suppliers
    
    
    Financial Risk Analysis & Controls
    
        1. Analysis Summary of Supplier Cost Differences
        2. Normalized Costs Comparator Information—Apples-to-Apples
        3. Details of Best-of-Breed suppliers and activities
        4. Recommendations to avoid delays and budget overruns
        5. Forms the basis of time and cost guarantees
    
    


Case Study
As seen in FIG. 26, the analysis and reports have a tremendous impact on the project budget. This figure shows three actual examples from recent actual clinical trials completed. The magnitude of the cost avoided is significant and this process has been able to consistently demonstrate where there are substantial cost savings (averaging over 30%) attainable.
FIG. 27 shows an example of the cover page of output in accordance with one preferred embodiment of the present invention.
FIG. 28 is an excerpt of the output that illustrates money saved by performing this process. This process saves time and eliminates waste and inefficiencies. The biotechnology company is assured that they get speed and protection, with no additional costs.
FIG. 29 shows an output that includes an analysis of risk based on the objectives of a particular trial using benchmark metrics.
The analysis includes a risk matrix calculation that provides the comfort and security that levels of exposure have been identified and analyzed. This analysis is specific to the points of risk of the trial and is seen in FIG. 30.
FIG. 31 gives the biotechnology company a calculation of several options and their effect on risk mitigation in enrollment, drug supply inventory, and the like.
FIG. 32 shows the comparison, of four alternatives in standardized categories as seen on the left. For example: Overall Assumptions, Project Management, Monitoring. Columns to the right quantifies units for each category. This reveals what is not included or not detailed. This standardization is not easy to make. The current embodiment of the invention provides this information. Importantly, reducing the scope, or reducing protections does not accomplish cost savings.
FIG. 33 shows dollars reclassified into standardized categories. This report revealed that although the total project budget appears similar, there are huge discrepancies within the categories. For example, monitoring activities vary from $454,000 to $1.2 million. There is an almost $1 million difference between the highest and lowest costs. Different suppliers treat passthrough costs (another category of activity costs) very differently, which can result in budget overruns.
FIG. 34 is an example of commentary and recommendations that accompany the other financial and risk reports.
FIG. 35 shows a report with per unit costs that compares vendors based on normalized costs. The gross monitoring cost per visit varies greatly between CRO1 and CRO2 EDC (electronic data capture). There are significant differences between the supplier who bid with less sites and/or a high unit cost. This lets the biotechnology company know how unit costs vary and who offers the best value.
FIG. 36 is a report of responsibilities and costs. It shows precisely who is doing what activities and itemizes each component and the responsible party. This shows the total budget with total transparency. These reports tie in to the reconciliations of costs during the conduct of the trial.
The present invention may be implemented with any combination of hardware and software. If implemented as a computer-implemented apparatus, the present invention is implemented using means for performing all of the steps and functions described above.
The present invention can be included in an article of manufacture (e.g., one or more computer program products) having, for instance, computer useable media. The media is encoded with, for instance, computer readable program code means for providing and facilitating the mechanisms of the present invention. The article of manufacture can be included as part of a computer system or sold separately.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention.

## Claims

1. An electronic method of analyzing budgets for clinical trials, the method comprising:
(a) inputting a clinical trial budget into a processor, the budget including activities and associated activity costs of a clinical trial, the activities including at least monitoring of clinical investigator sites that are conducting the clinical trial;
(b) classifying the activities of the inputted clinical trial budget into a set of standardized service categories;
(c) electronically allocating, using the processor, the associated activity costs with the respective standardized service category so that budget costs of the clinical trial can be objectively analyzed; and
(d) outputting a report of the associated activity costs with the respective standardized service category for use in analyzing budgets for clinical trials.

2. The method of claim 1 wherein the clinical trial further includes a set of assumption specifications of the clinical trial, the method further comprises:
(e) inputting the set of assumption specifications into the processor, the assumption specifications including at least the number of patients involved in the clinical trial;
(f) calculating per unit costs of the assumption specifications; and
(g) outputting a report of the per unit costs of the assumption specifications for use in analyzing budgets for clinical trials.

3. The method of claim 2 further comprising:
(h) equalizing the activities and the associated activity costs against reference assumption specifications based on at least the per unit costs; and
(i) outputting a report of the equalized activity costs for use in analyzing budgets for clinical trials.

4. The method of claim 2 further comprising:
(h) using the per unit costs to compare the activities and the associated activity costs to reference assumption specifications.

5. The method of claim 1 wherein step (b) is performed automatically by the processor.

6. The method of claim 5 wherein step (b) further comprises using an electronic translator to automatically perform at least some of the classification, wherein the electronic translator includes a dictionary of activities and their associated standardized service categories.

7. An electronic method of analyzing budgets for clinical trials, the method comprising:
(a) inputting a clinical trial budget into a processor, the budget including assumption specifications of a clinical trial, activities of the clinical trial, and associated activity costs of the clinical trial, the activities including at least monitoring of clinical investigator sites that are conducting the clinical trial;
(b) calculating in the processor per unit costs of the assumption specifications;
(c) equalizing the activities and the associated activity costs against reference assumption specifications using at least the per unit costs via calculations performed in the processor so that budget costs of the clinical trial can be objectively analyzed; and
(d) outputting a report of the equalized activity costs for use in analyzing budgets for a clinical trial.

8. An article of manufacture for analyzing budgets for clinical trials, the article of manufacture comprising a computer-readable medium encoded with computer-executable instructions for performing the steps of:
(a) inputting a clinical trial budget into a processor, the budget including activities and associated activity costs of a clinical trial, the activities including at least monitoring of clinical investigator sites that are conducting the clinical trial;
(b) classifying the activities of the inputted clinical trial budget into a set of standardized service categories;
(c) electronically allocating, using the processor, the associated activity costs with the respective standardized service category so that budget costs of the clinical trial can be objectively analyzed; and
(d) outputting a report of the associated activity costs with the respective standardized service category for use in analyzing budgets for clinical trials.

9. The article of manufacture of claim 8 wherein the clinical trial further includes a set of assumption specifications of the clinical trial, and the computer-readable medium is encoded with computer-executable instructions for performing the further steps of:
(e) inputting the set of assumption specifications into the processor, the assumption specifications including at least the number of patients involved in the clinical trial;
(f) calculating per unit costs of the assumption specifications; and
(g) outputting a report of the per unit costs of the assumption specifications for use in analyzing budgets for clinical trials.

10. The article of manufacture of claim 9 wherein the computer-readable medium is encoded with computer-executable instructions for performing the further step of:
(h) equalizing the activities and the associated activity costs against reference assumption specifications based on at least the per unit costs; and
(i) outputting a report of the equalized activity costs for use in analyzing budgets for clinical trials.

11. The article of manufacture of claim 9 wherein the computer-readable medium is encoded with computer-executable instructions for performing the further step of:
(h) using the per unit costs to compare the activities and the associated activity costs to reference assumption specifications.

12. The article of manufacture of claim 8 wherein step (b) is performed automatically by the processor.

13. The article of manufacture of claim 12 wherein step (b) further comprises using an electronic translator to automatically perform at least some of the classification, wherein the electronic translator includes a dictionary of activities and their associated standardized service categories.

14. An article of manufacture for analyzing budgets for clinical trials, the article of manufacture comprising a computer-readable medium encoded with computer-executable instructions for performing the steps of:
(a) inputting a clinical trial budget into a processor, the budget including assumption specifications of a clinical trial, activities of the clinical trial, and associated activity costs of the clinical trial, the activities including at least monitoring of clinical investigator sites that are conducting the clinical trial, and the assumption specifications including at least the number of patients involved in the trial;
(b) calculating in the processor per unit costs of the assumption specifications;
(c) equalizing the activities and the associated activity costs against reference assumption specifications based on at least the per unit costs via calculations performed in the processor; and
(d) outputting at least one of (i) a report of the per unit costs of the assumption specifications, and (ii) a report of the equalized activity costs, for use in analyzing budgets for a clinical trial.

15. The method of claim 1 wherein steps (a)-(d) are performed for a plurality of budgets for the same clinical trial, the method further comprising:
(e) generating, using the processor, a comparison report showing at least some of the standardized service categories and the associated activity costs for each of the plurality of budgets.

16. The method of claim 7 wherein steps (a)-(d) are performed for a plurality of budgets for the same clinical trial, the method further comprising:
(e) generating, using the processor, a comparison report showing at least some of the activities and the associated activity costs for each of the plurality of budgets.

17. The article of manufacture of claim 14 wherein steps (a)-(d) are performed for a plurality of budgets for the same clinical trial, the method further comprising:
(e) generating, using the processor, a comparison report showing at least some of the activities and the associated activity costs for each of the plurality of budgets.