1. GCP/QA SIAC Member Meeting 19 January 2007 Pamela Rose, Session Chair
Clinical Trial Registries and Results Databases: Are you Ready for the Audit?
GCP/QA SIAC Member Meeting
19 January 2007
Pamela Rose, Session Chair

2. Session Presenters
Pamela Rose, Director, Clinical Trial Information Registries, TAP
Maureen Strange, Clinical Trial Registration Gatekeeper, Lilly
Tracy Beck, Clinical Trial Results Gatekeeper, Lilly
John McKenney, SEC Associates

3. Session Learning Objectives
Describe the audit plan used for auditing clinical trial registries and results databases.
Discuss the lessons learned after auditing clinical trial registries and results databases.
Learn similarities and differences of Disclosure audit and FDA audit.
Learn the unique processes that may be required when auditing disclosure registries and databases.

4. What is Clinical Trial Disclosure
Clinical Trial Disclosure is providing clinical trial protocol information and results on a publicly accessible website in a timely manner
Should not be confused with Phase 4 patient or disease registries

5. Goals of Clinical Trial Disclosure
Provide information sufficient for patients to enroll in clinical trial
Enhance accountability and transparency of clinical trial information
Provide access to results of clinical trials in a comprehensive and objective manner
Improve industry reputation

6. Acronyms AAMC: Association of American Medical Colleges
CTR: Clinical Trial Registry
FDAMA: Food and Drug Modernization Act
FACT Act: Fair Access to Clinical Trials Act
ICMJE: International Committee of Medical Journal Editors
IFPMA: International Federation of Pharmaceutical Manufacturers and Associations
IOM: Institute of Medicine
NIH: National Institutes of Health
PhRMA: Pharmaceutical Research and Manufacturers of America
WHO: World Health Organization
ICTRP: International Clinical Trials Registry Platform

7. Public Disclosure of Study Information
Clinical Trial Life Cycle
Part 2: Post Trial Results
Part 1: Register
Protocol Information
Within 21 days of enrollment of first subject
One year after trial completion: Marketed drugs
clinicaltrials.gov
clinicalstudyresults.org

8. Clinical Trial Disclosure Landscape
Inputs PhRMA AAMC IFPMA AMA Ottawa Grp Countries
FDAMA NIH Congressional Acts ICMJE IOM WHO-ICTRP States
clinicaltrials.gov
clinicalstudyresults.org
Script
Many different organizations have been issuing regulations and guidance related to sharing clinical trial information publicly. Not only does this tie to the FDA Modernization Act of 1997, but also to U.S. legislation, guidance by medical journal editors, the pharmaceutical industry itself, and others.
Perhaps the text below can float when arrow touches the associated point?
FDA Modernization Act 1997 Section 113: Study Sponsors of serious and life-threatening conditions are required by law to register study information on Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions, March, 2002 can be viewed at
NIH: National Institutes for Health: NIH investigators are also expected to input study information into clinicaltrials.gov.
FACT Act: Fair Access to Clinical Trials Act (S470). Currently being reviewed in the house and senate. This bill can be found at
ICMJE: International Committee of Medical Journal Editors. Includes 11 journals, including NEJM, Annals, Lancet, JAMA, and others. ICMJE has issued an editorial stating that Study Sponsors must register study information from all hypothesis-testing studies before enrollment of the first subject to ensure acceptance and review of the study results manuscript. This editorial can be found at
IFPMA: International Federation of Pharmaceutical Manufacturers and Associations. Members of IFPMA include European, Japanese and US Associations. IFPMA issued guidance stating that Study Sponsors will register study information from all hypothesis-testing studies (all phase 3, and some phase 1,2 and 4 studies) into
PhRMA: Pharmaceutical Research and Manufacturers Association. ­ Issued “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.” in October 2002, updated June 2004, and gave guidance stating that Study Sponsors will register study information from all hypothesis-testing studies (all phase 3, and some phase 1,2 and 4 studies) into These documents can be viewed at PhRMA also sponsors a clinical study results database at
State of Maine has passed legislation (H.P.1141-L.D Sec MRSA c. 605) requiring all manufacturers marketing drugs in Maine in the Maine Care and Senior Care programs to register all studies into and pay Maine $1000 per year to cover Maine’s expense for managing this program.
IOM: Institute of Medicine sponsored a workshop June 2005 to discuss Clinical Trial Registries, generating a summary paper on developing a national registry.
AMA: American Medical Association: The AMA supports a national clinical trial registry. Their Journal, JAMA, is a member of ICMJE.
Ottawa Group: A group of Researchers, Editors and Meta-analysis groups (Cochrane group) led by Canadian Institutes of Health Research. A Statement outlining a set of guiding principles for the development of trial registers was generated after an open meeting was held October 4, 2004 in Ottawa, Canada. The statement can be viewed at
WHO: World Health Organization: WHO generated a basic statement on clinical trial registration standards in April 2005 after a consensus meeting held in Geneva. The outcome summarized what should be registered and drafted the basic requirements for a minimum dataset. WHO has instituted a group to develop worldwide standards for registering clinical trials, the International Clinical Trials Registry Platform (ICTRP). Additional information can be found on
Users
Systematic Reviewers (Cochrane, Oregon)
Health Policy Makers
Journal Editors
Researchers & Funders
Consumer Advocates
Recruitment (Patients, doctors)

9. Disclosure History Hope Act 1988 1988 1997 2000 2002 2004 2005 2006
IOM Safety Review
VIOXX and PAXIL
Matters
State of Maine Law
Enzi Kennedy Act introduced
PhRMA Principles
Hope Act 1988
FDAMA 113 Law
ICMJE Editorial
WHO ICTRP
FACT Act
clinicaltrials.gov
1988
1997
2000
2002
2004
2005
2006
Register AIDs Studies
Register to Publish
Register all studies for drugs marketed in Maine
Register studies on Serious, Life Threatening Illnesses
Registry and Results Disclosure
Register all hypothesis-testing studies
Registry Standards
Law
Guidance
Law

10. Current Disclosure Law/Guidance
Registration
Law
FDAMA 113
State of Maine
Guidance
ICMJE
PhRMA
IFPMA
WHO
Results Disclosure
Law
State of Maine
Guidance
PhRMA
IFPMA

11. Ensure Accuracy of Disclosed Information
Why?
To build public trust
To comply with law and company policies
It’s the right thing to do
How?
Implement good computer/electronic records practices
Apply Quality Control techniques
Audit disclosed information for accuracy
Audit processes and procedures

12. Key References
Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions, March,
ICMJE Editorial,
PhRMA “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.” October
State of Maine Legislation, (H.P.1141-L.D Sec MRSA c. 605).
IFPMA Joint Statement,
WHO Statement,