1. DIA GCP/QA SIAC All Member Meeting
Pamela Rose
Takeda Global Research and Development Inc.

2. Clinical Trial Transparency is Here to Stay…
Researchers are required to disclose clinical trial protocol information and results
Many stakeholders (academic centers, governmental agencies, patient advocacy groups, etc)
WHO recommends registration of all trials
Every year, more countries are requiring registration and results disclosure
23 April 2009

3. Some of the Challenges…
Transparency without compromising drug development
Global, multi center trials
Multiple country registrations with varying requirements (content, timing)
Results format varies by country
Consistency of information
Update one country registration; update them all
Documentation of registration
Company processes
Process for posting results on clinicaltrials.gov
23 April 2009

4. PhRMA Principles updated
Announced at the NIH Public Meeting 20 April 2009
Effective October 1, 2009
Register all clinical trials involving patients
Post results summaries for all clinical trials involving patients for approved medicines as well as medicines whose research programs are discontinued.
23 April 2009

5. NIH Public Meeting Issues for Discussion
Post results of unapproved products?
Post data summaries without being misleading or promotional?
Post non-technical summaries? What information? Who should write them?
Post full protocol?
Procedures the Agency should consider for QC
Increase results posting timing to 18 months after LSLV of Primary Outcome?
Post results for studies registered before effective date of the regulation?
Appropriate timing for registration updates
Standard format for submission of required basic results
Statement that should accompany voluntary registrations
Other
23 April 2009

6. NIH Public Meeting Pre-registered Speakers
Katie McCarthy: BIO
Francis Crawley: GCP Alliance
Lisa Griffin Vincent: AdvaMed
Edward Campion: NEJM
Gordon Johnston: GPhA
William Vaughan: Consumers Union
Jeffrey Francer: PhRMA
Howard Rutman: Taro Pharmaceuticals Inc.
Carlea Bauman: C3 Colorectal Cancer Coalition
23 April 2009

7. NIH Public Meeting Key Points
Submit comments to the Docket until 22 June 2009
NLM
71,398 Trials registered on CTgov
678 results submitted
Expect results will be clear, informative and will be understood by someone who doesn’t know about the trial
FDA
7 working groups implemented
Challenges include unclear language, technical issues, unrealistic statutory deadlines, integration of NLM and FDA procedures, multiple stakeholders
23 April 2009

8. NIH Public Meeting Key Points
BIO
Post ICH E3 synopsis
Post results from trials discontinued due to safety issues
Information posted should be useful and understandable
GCP Alliance
Post results of all trials
Post complete protocol
23 April 2009

9. NIH Public Meeting Key Points
AdvaMed
Post results of trials discontinued for safety reasons
Create text/check box for waiver/delay
No posting of complete protocol
Add text area on SAE section
NEJM
Posting results on CTgov will not be a barrier to publishing on NEJM
Results posting should Not include narrative summary; risk of overinterpretation
Post AE Facts only; distinguish between major and minor effects
23 April 2009

10. NIH Public Meeting Key Points
GPhA
Generic Bioequivalence studies should not be registered
Consumers Union
Results should be public
Register phase 1 trials
Narrative summaries cannot be trusted
FDA should hire scientists to review data and write narratives
Collect full protocol; release if requested
Post results within 1 year LPLV
23 April 2009

11. NIH Public Meeting Key Points
PhRMA
Register trials conducted in patients
Post results summaries for all clinical trials involving patients for approved medicines as well as medicines whose research programs are discontinued
Post technical ICH E3 synopsis
Study best way to generate lay summary
AE information should be consistent with FDA requirements
Do not post full protocol
23 April 2009

12. NIH Public Meeting Key Points
Taro Pharmaceuticals
Bioequivalence studies for generics should not be registered prior to approval
C3 Colorectal Cancer Coalition
Results should be understandable
Results should all be in one database
Canadian Representative
Consider international format/impact
23 April 2009

13. NIH Public Meeting Key Points
King and Spaulding
AE %/frequency should be presented on the table instead of requiring reader to calculate
Consumer Advocate/Journalist
Post all results, especially early stage failures
Include narrative summary
23 April 2009

14. Contact Information
Pamela Rose
Associate Director, Clinical Trial Registration and Results Disclosure
Takeda Global Research and Development Inc.
Office:
23 April 2009