# Presentation: 075716

## Ken Buetow, Ph.D.
Director,Center for Biomedical Informatics and Information Technology

**NCI Clinical Trials Database Implementation Plan**

***Ken Buetow, Ph.D.***
*Director,**Center for Biomedical Informatics **and Information Technology*

## CTWG Theme: Coordination

**	***“**The CTWG envisions an enhanced cancer clinical trials enterprise in which increased participation by the extramural community in the prioritization process more effectively focuses resources on those trials judged most likely to facilitate advances in treatment. The success of this strengthened prioritization process depends on a**** ******shared foundation of comprehensive, up-to-date information about the status of cancer clinical trials****.”*
*	**-**	**CTWG Report*

## Four Related Informatics-focused Initiatives

- Establish a comprehensive database containing regularly-updated information on all NCI-funded clinical trials (***Clinical Trials Database)***** ***** ***
- Promote the establishment of a National Clinical Trial Information Technology Infrastructure that is fully interoperable with caBIGTM (***System Interoperability & Harmonization)***
- Develop standard case report forms that incorporate common data elements, in consultation with industry and the FDA (***Case Report Forms)***
- Develop a repository of investigator and site credentials that is recognized and accepted by NCI, industry sponsors, clinical investigators and clinical trial sites (***Investigator & Site Credentialing Repository)***

**Notes:**
Ken – Please explain here that SIH, although it is one initiative, we have broken it into 2 projects:  SIH and Study Initiation Tool... This is important because SIT doesn’t appear again until the end of the Implementation Plans

## Four Related Informatics-focused Initiatives

- Establish a comprehensive database containing regularly-updated information on all NCI-funded clinical trials (***Clinical Trials Database)***** ***** ***
- Promote the establishment of a National Clinical Trial Information Technology Infrastructure that is fully interoperable with caBIGTM (***System Interoperability & Harmonization)***
- Develop standard case report forms that incorporate common data elements, in consultation with industry and the FDA (***Case Report Forms)***
- Develop a repository of investigator and site credentials that is recognized and accepted by NCI, industry sponsors, clinical investigators and clinical trial sites (***Investigator & Site Credentialing Repository)***

**Notes:**
Ken – Please explain here that SIH, although it is one initiative, we have broken it into 2 projects:  SIH and Study Initiation Tool... This is important because SIT doesn’t appear again until the end of the Implementation Plans

## Comprehensive, Community- Accessible NCI Clinical Trials Database 

**A single source for NCI clinical trial data**
**Transparency on the status of clinical trials**
**Enhanced ability to mine, compare and analyze data across trials**
**Potential to expand the database to include data from other sponsors (public and private sector)**
**Leveraging of NCI’s experience and expertise in the design, development and maintenance of clinical trials databases**

**Notes:**
Benefits
  Establishing a NCI Clinical Trials Repository:
  Provides opportunity for Research Community involvement and input  
  Provides one source for all clinical trials information for researchers, physicians and patients
  Will facilitate routine review of safety, efficacy, and administrative data reported from on-going cancer trials
  Allows for better informed allocation and investment of resources based in improved data quality and veracity 

**Workflow for Clinical Trials Database**

- Principle Investigator
- registers with NCI Clinical Trials Portal

- CDUS Abbreviated patient-level data
- submitted via CDS Web (or FTP)

- Comprehensive accrual data accessible via CDS Analysis / Reporting Module

- Trial is registered (and protocol document
- uploaded) in NCI Clinical Trials Portal

- NCI abstracts protocol from document into
- CDS  to support query and reporting

** **

**Workflow for Clinical Trials Database**

- Principle Investigator
- registers with NCI Clinical Trials Portal

- CDUS Abbreviated patient-level data
- submitted via CDS Web (or FTP)

- Comprehensive accrual data accessible via CDS Analysis / Reporting Module

- Trial is registered (and protocol document
- uploaded) in NCI Clinical Trials Portal

- NCI abstracts protocol from document into
- CDS  to support query and reporting

## Protocol Registration Data Elements: Common Data Elements (CDEs) Identified

**  ****Lead Organization**
**  ****Lead Organization Protocol ID**
**  ****Principal Investigator**
**  ****Sponsor**
**  ****Protocol Title**
**  ****Protocol document/consent document**
**  ****Trial Type**
**  ****Trial Phase**
**  ****Accrual Status**
** ****Accrual Status date**

## NCI Clinical Trials Portal

## Submitter Self Registration – Instant Access

## Trial Registration and Protocol Document Upload

** **

**Workflow for Clinical Trials Database: #2**

- Trial submitter
- registers with NCI Clinical Trials Portal

- CDS Abbreviated patient-level data
- submitted via CDS Web (or FTP)

- Comprehensive accrual data accessible via CDS Analysis / Reporting Module

- Trial is registered (and protocol document
- uploaded) in NCI Clinical Trials Portal

- NCI abstracts protocol from document into
- CDS-PA to support query and reporting

** **

**Workflow for Clinical Trials Database: #3**

- Trial submitter
- registers with NCI Clinical Trials Portal

- CDS Abbreviated patient-level data
- submitted via CDS Web (or FTP)

- Comprehensive accrual data accessible via CDS Analysis / Reporting Module

- Trial is registered (and protocol document
- uploaded) in NCI Clinical Trials Portal

- NCI abstracts protocol from document into
- CDS-PA to support query and reporting

## CDUS Content

**caBIG CTMS Steering Committee endorsed systematic reporting of all trials using the Clinical Data Update System (CDUS) core data elements**
- Utilized by CTEP and DCP
- Similar content to NCI Center’s Program Summary 4

## CDS Web Accrual / Demographics Screen

**CDS Web Accrual / Demographics Screen**

## CDS Web Accrual / Demographics Screen (continued) 

**CDS Web Accrual / Demographics Screen (continued) **

** **

**Workflow for Clinical Trials Database: #4**

- Trial submitter
- registers with NCI Clinical Trials Portal

- NCI abstracts protocol from document into
- CDS-PA to support query and reporting

- CDS Abbreviated patient-level data
- submitted via CDS Web (or FTP)

- Comprehensive accrual data accessible via CDS Analysis / Reporting Module

- Trial is registered (and protocol document
- uploaded) in NCI Clinical Trials Portal

## Available Reports for Selected Protocols

**Available Reports for Selected Protocols**

## Next Steps for the Clinical Trials Database

**Assemble NCI Policy Implementation Teams to address:**
- “Legacy” data migration
- Protocol abstraction
- Quality Control and Quality Assurance
- Ensure generation of Summary 4 and ClinicalTrials.gov submissions
**Develop timeline to coordinate activities**

## Moving Forward – Who/what is reported

**Additional** registration/reporting is **not** required for trials already reported to CTEP / DCP – NCI will transfer information
- Reporting is required for **interventional trials only **(for now)** **
**For NCI-sponsored trials: **Reporting will be at the PI level (*i.e.*, the PI’s office will be responsible for reporting for all sites)
**For non-NCI-sponsored trials **at NCI-designated Cancer Centers**, including investigator-initiated : **Reporting will be at the site level.

## Moving Forward - Timelines

- .
- Initially, **new trials** initiated after production date of 1/1/2009 must be entered **within 21 days after activation**
**All active trials** must be entered **within six months** (*i.e.*, by 6/30/2009)
- Starting 7/1/2009, **quarterly reporting of all trial updates** will be required (*i.e.*, immediate submission of every amendment is not required)
- Starting 7/1/2009, **quarterly entry of accrual information** will be required.

## Phased Deployment: Preparation

- Six-month NCI preparation period starting January 1, 2008
- Educational documents (including SOPs) being assembled
- Informational web site being assembled
- Master lists of grant recipients being assembled
- Potential sites for the operational pilot will be identified and recruited
- Information will be prepared for dissemination to sites about pending requirements
- Contracting vehicles for NCI QA / abstraction staff identified and initiated
- Help desk staff will be trained
- Data elements are being identified, and included within the informatics infrastructure, to fulfill requirements of Cancer Center Summary 4 Report / FDA Amendments Act of 2007

## Phased Implementation: Deployment

- Operational Pilot (July-December 2008)
- Approximately five sites will be selected for pilot
- Sites will receive compensation for participation in pilot
- Release 1: Production (January-December 2009)
- Updated protocol detail data elements to fulfill:
- Cancer Centers Branch Summary 4 Report
- Trial registration to NIH per FDA Amendments Act of 2007
- Quarterly patient-level reporting of accruals starts July 2009
- Quarterly protocol updates (amendments, etc.) starts July 2009
- Release 2: Outcome Reporting (pilot starts January 2010)
- Adverse events and outcomes reporting
- Reporting of AEs / outcomes to NIH as per FDA Amendments Act
- A pilot will be required

## Timeline

**Operational Pilot (pilot sites only) **

**All open trials must be registered within six months (by June 30, 2009) **

- July 2008

- January 2009

- July 2009

- January 2008

- January 2010

**Timeline**

-  **7/1/2008:** Pilot sites begin registration of trials, submission of quarterly amendments / accruals

-  **1/1/2009:** Production phase starts: registration of all new trials required within 21 days of activation, begin registration of all open trials

-  **7/1/2009:** All open trials must have been submitted by this point; sites begin submission of accruals / updates

**Accruals and protocol updates must be submitted once per quarter, starting July 2009 – first deadline is September 30, 2009**

-  **9/1/2008:** First quarterly submission of accruals / protocol updates

**Pilot of outcome /**
**AE submission (pilot sites only) **

**1/1/2010:** First generation of Summary 4 report

**1/1/2010:** Pilot sites begin outcome / AE submission

**Preparation/education**

**NCI Abstraction / QA **

## Public Law 110-85, aka HR 3580, aka FDA Amendments Act

## Questions?