# Presentation: 515926

## Current approaches to registration and monitoring of clinical trials

- Summary of survey distributed to the caBIG CTMS working group participants (10/26/04)

## Survey Overview

- Sixteen item survey developed by University of Pittsburgh Cancer Institute CTMS team
- Sent via e-mail to 67 caBIG CTMS working group participants at 31 institutions
- Received 13 completed surveys (42% return-rate)
- Majority of summary that follows is directly from survey responses	*
- Identified needs/concerns at end of summary are a combination of written survey responses and information gathered from stakeholder interviews at UPCI, UC Irvine, City of Hope, and Wake Forest.

** Question 9 regarding data model/schema for systems is not presented here.  Few responses were provided to this question.*

## Institutions completing survey (N=13)

- Chao Family Comprehensive Cancer Center** **(UC Irvine)
- Georgetown University
- Holden Comprehensive Cancer Center (Univ. of Iowa)
- Karmanos Cancer Institute
- Mayo Clinic Cancer Center
- MD Anderson Cancer Center
- Norris Cotton Cancer Center (Dartmouth)
- Oregon Health Sciences University Cancer Institute
- University of Minnesota
- University  of Nebraska Medical Center
- University of Pennsylvania
- Veterans Affairs
- Wake Forest University

## Clinical Trials Environment Overview

- Number of **clinical trials** institution initiates annually, on average:  **16 to 200+**
- Note: some respondents identified “cancer-specific” trials or “trials of interest to caBIG”
- Number of** ****patients** enrolled in clinical trials:  **150 to 13,000+**
- 46% of respondents (6/13) use 2 or more clinical trial systems
- Four centers report using spreadsheets or standalone databases in conjunction with commercial or server-based systems
- Two centers (15%) rely only on spreadsheets or a standalone database for their clinical trial system
- 77% of respondents enter trial information into system prior to first review of the protocol

- (Survey Items 1,2,3,10)

## Clinical trials data system currently in use*

| 5 | Commercial product  |
| --- | --- |
| 4 | Standalone relational database  |
| 4 | Other  |
| 5 | Multi-tiered database web server  |
| 3 | Spreadsheet or other non-relational electronic system  |
| 2 | Multi-tiered database server with dedicated client software  |

**** **More than one system could be selected**.*

- (Survey Item 3)

## Clinical trials data systems

- 	_Commercial Products_
- Oncore by PercipEnz (2)
- DATALABS
- Oracle Clinical
- Surveyor (Perspective Suite) by PerMedics

- _Other_
- BMT database, homebrew (Oracle)
- VA home grown .NET based system
- Standalone document management system; currently developing a clinical trial data management system
- client/server, relational database, web reporting

- (Survey Item 3)

## Data Entry Mode(s)

| 13 | Manual entry of data*  |
| --- | --- |
| 7 | Manual merging of electronic data files  |
| 4 | Direct database-to-database interconnectivity (plus 1 planned) |
| 2 | Text scanning and encoding technology  |

** Only 3 centers rely on manual entry exclusively.*

- (Survey Item 4)

## Levels of System Access

| Level | Description and/or Roles: |
| --- | --- |
| Full Control  | System administrator, DBA, Developer |
| Read/Write  | Content editor, Data Manager, Nurse  |
| Read Only  | Read data for trial, PI  |
| Protocol Manager  | Protocol level, manage data for trial  |
| Restricted Data Access  | Application testing, hide sensitive data, double-blinded trials, access to/from other institutions, cannot see certain data  |
| Tailored access  | Role level security specific to studies, create own within protocol or group of protocols, distributed in intra and inter fashion through multiple roles assignments  |

- (Survey Item 5)

## Trial Identification

- A number is assigned
- Examples of what is captured in number:
- Year of protocol
- Disease site or program
- Sequential number of protocol
- Study type (local, multi-center, etc.)
- Other numbers for studies also exist
- Sponsor #, IRB #, NCI #, Cooperative Group #

- (Survey Item 6)

## Patient Identification

- Patient number is assigned
- Sometimes tied to specific protocol
- Examples of what is captured in number:
- Combination partial birth date, race, sex, initials
- Medical Record Number or Social Security Number
- Protocol enrollment sequence number
- May use sponsor or cooperative group study identification system
- Number is sometimes generated internally (i.e., invisible to basic user)

- (Survey Item 7)

## IRB-Related Data

- Examples of what is commonly captured:
- Study Information
- Protocol Title, Phase, Title, Drug, Description, Sponsor, Eligibility, etc.
- PI Information
- sometimes contact person, CRC, co-investigator as well
- Dates
- submission, approval, amendments, annual review, trial open/closed, etc
- IRB Number & Review Type
- Protocol status
- Documents & associated dates
- initial protocol, consent, approval letters, etc.
- Events (e.g., audits dates, committees, outcomes)
- Adverse events
- Required information for IRB reports (e.g., data safety monitoring reports)
- Summary 4 data – (e.g., sponsor, site code, etc)
- May be captured for 2+ review committees

- (Survey Item 8)

## IRB Information Transfer

| 12 | Paper documents |
| --- | --- |
| 6 | E-mailing of documents in electronic form |
| 3 | Software application developed for this purpose (3 additional sites planning for this) |

- (Survey Item 11)

## Process of Registering a Clinical Trial

- PI				Authors protocol
- 				[preliminary internal review]
- Research Coordinator(RC)	Obtains/generates # for protocol
- RC*				Enters protocol information
- RC				Submits protocol documents to 					IRB and other review committees
- 				Monitors IRB approval
- IRB/review committees		Communicates status
- RC				Enters IRB data
- 				Attaches consent
- 				[secure other approvals – e.g., fiscal]
- 				Opens trial to accrual
- 				Ongoing data entry

**or manager of scientific review committee; Office of  Protocol research; database support team; QA dept.; etc.*

- (Survey Item 12)

**Notes:**
I’ll draw a diagram of this tonight.

## Process of Enrolling Patients

- 				[check eligibility]
- 				Enter patient name, MRN, race, 					ethnicity, gender, DOB, etc. into 					system
- 				[check eligibility, consenting process]

**or Study Research Coordinator, Research Nurse, QA Dept., Data Manager, etc.*

- (Survey Item 13)

- Other patient-related tasks mentioned include: completing Case Report Forms, SAE entry, creating protocol calendars, and entering follow-up data.

**Notes:**
I’ll draw a diagram of this tonight.

## Changing Trial Status

- (Survey Item 14)

- Changes protocol status field
- Notifies IRB / Key Staff

- Research Coordinator

**Or Safety Data Monitoring Committee Coordinator, Admin. Assistant, Regulatory Specialist, Office of Protocol Research, etc.*

- *

- PI *and/or* Safety Data Monitoring Committee

- Sponsor, Cooperative Group, Data Safety Monitoring, FDA Advisories

***Other triggers include: no accrual, low accrual, maximum accrual reached; auditor’s quality concerns; trial in database that has never opened to accrual.*

**Notes:**
I’ll draw a diagram of this tonight.

## Miscellaneous additional features of existing systems

- Verifying IRB approval
- Checking eligibility status
- Monitoring accrual rates
- Flagging trials that haven’t changed from initial “new” status
- Notifying others of status changes

## Needs/concerns identified in survey, interviews 

- Tracking during review process
-  of IRB submission documents
-  of review process workflow
- Flexibility
- search to answer ad hoc queries (e.g. “I’m looking for a breast trial that had something to do with bone density.”)
- option to specify “unknown”, “other”, or “multiple” for (almost) every field (also rule circumvention/exceptions)
- handling cooperative group trials, multi-site trials, differently from hypothesis-driven investigator-initiated trials.
- Parallel use of terms,  classifications, and identifiers required for reporting with those recognized internally

**Notes:**

The flexibility and parallel use bullets support the need for a representation that can accommodate institution-specific differences in representation and interface.

## Needs/concerns identified in survey, interviews (2)

- Automated reminders and notifications
- of protocol milestones that require attention (e.g. expirations, delay after IRB submission)
- of protocol status changes
- Consolidation of data
- centralized storage of the clinical trials data needed to create reports for internal and external reporting, or a mechanism for pulling the required data from the existing variety of databases and spreadsheets
- elimination of redundancy among internal databases or between IRB’s database and other clinical trials databases

## Needs/concerns identified in survey, interviews (3)

- Support for investigators to ensure that all required elements of protocols are included
- Integrated tools to record workload/time on task, for use in explaining duration of approval process  and justifying new FTEs
- Calendar of all patient events, by clinical coordinator
- Summary views of trials open to accrual, patients screened, patients in study
- Improved handling of Case Report Forms (to be explored further)

## Needs/concerns identified in survey, interviews (4)

- Minimizing costs for obtaining and storing clinical trials data
- Dealing with disparate technologies/platforms on the same campus
- Generating core grant reports
- Not overloading protocol managers with data entry requirements
- Integrating with other systems such as labs, IRB, local and statewide tumor registries, etc.
- Coordinating multi-center database access, data collection, and reporting

## Needs/concerns identified in survey, interviews (5)

- Other broad concerns mentioned:
- Financial/Billing
- De-Identification
- CDE consistency
- Security
- HIPAA

## Contact Information

- If you have any questions about this survey summary, please contact:
- Linda Schmandt, _[lms@pitt.edu](mailto:lms@pitt.edu)_
- Valerie Monaco, _[monacov@upmc.edu](mailto:monacov@upmc.edu)_