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Everything You Ever Wanted to Know About ClinicalTrials

Everything You Ever Wanted to Know About ClinicalTrials

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Everything You Ever Wanted to Know About ClinicalTrials

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  1. Everything You Ever Wanted to Know About ClinicalTrials.gov (Slides for presentation only.) Deborah A. Zarin, M.D. Director, ClinicalTrials.gov May 2010

  2. Background

  3. What’s All The Fuss About? • Suppression of research results impedes the scientific process • Suppression of clinical trial data is particularly problematic: • Trials depend on human volunteers; • Trial results inform our medical decisions 3

  4. Screen shot of Washington Post article. A Silenced Drug Study Creates An Uproar. By Shankar Vedantam Wednesday, March 18, 2009 • “The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers.” • “The results of Study 15 were provided only to the Food and Drug Administration -- and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain.”

  5. Screen shot of : Lilly Sold Drug for Dementia Knowing It Didn’t Help, Files Show By Margaret Cronin Fisk, Elizabeth Lopatto and JefFeeley “Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic... after [it] sent study results to the U.S. Food and Drug Administration” showing Zyprexa didn’t alleviate dementia symptoms in older patients…”

  6. Screen shot of : The New England Journal of Medicine Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use S. SwaroopVedula, M.D., M.P.H., Lisa Bero, Ph.D., Roberta W. Scherer, Ph.D., and Kay Dickersin, Ph.D. N Eng J Med. 2009 Nov 12;361:1963-71

  7. Reasons to Register Clinical Trials and Report Results • Human Subject Protections • Allows potential participants to find studies • Assists ethical review boards and others to determine appropriateness of studies being reviewed (e.g., harms, benefits, redundancy) • Promote fulfillment of ethical responsibility to human volunteers – research contributes to medical knowledge • Research Integrity • Facilitates tracking of protocol changes • Increases transparency of research enterprise • Evidence Based Medicine • Facilitates tracking of studies and outcome measures • Allows for more complete identification of relevant studies • Allocation of Resources • Promotes more efficient allocation of resources

  8. Levels of “Transparency” 8 Zarin DA, Tse T.. Science. 2008 Mar 7;319(5868):1340-2.

  9. 10th Anniversary of ClinicalTrials.gov 2000 - 2010

  10. History of ClinicalTrials.gov FDAMA 113 (1997): Mandates Registry IND trials for serious and life-threatening diseases ClinicalTrials.gov Launched in February 2000 ClinicalTrials.gov Accommodates Other Policies Registration Int’l Committee of Medical Journal Editors (ICMJE) World Health Organization (WHO) Registration and Results Reporting Maine State Law; State Attorneys General European Medicines Agency (EMA) FDAAA 801 (2007): Expands Registry and Adds Results Database 10 10 10

  11. FDAAASec.801 Expanded Clinical Trial Registry Enacted on September 27, 2007 Requires Trial Registration (Dec 2007) Phase II-IV drug and device trials for all diseases Data elements: ClinicalTrials.gov + ~ WHO/ICMJE Requires Results Reporting (Sept 2008) Trials of FDA-approved or cleared drugs and devices “Basic” Results: Baseline Characteristics, Primary & Secondary Outcomes, Statistical Analyses Adverse Events (Sept 2009) “Expansion” of results by rulemaking (Sept 2010) Added enforcement provisions 11 11 11 11

  12. Trial Reporting:The Bottom Line Based on All Policies • Register all interventional studies prior to enrollment of the first participant • Keep entries up to date • Report results for trials subject to FDAAA: • Drugs, devices, biologics • Not Phase 1 • One year after “primary completion date” (unless special circumstances apply)

  13. ClinicalTrials.gov—the Basics

  14. ClinicalTrials.gov Statistics(as of 5/24/2010) • Number Percent • Total 90,137 100% • Type of Trial • Observational 15,252 17% • Interventional 74,107 83% • Drug & Biologic 53,628 • Behavioral, Gene • Transfer, Other 15,373 • Surgical Procedure 9,227 • Device* 5,538 • International Sites (172 countries) • US only 41,513 46% • Non-US only 33,414 37% • US & Non-US mixed 5,823 6% • Missing 9,387 10% 14 *287 applicable device clinical trials submitted, but qualify for “delayed posting” under FDAAA

  15. ClinicalTrials.gov Statistics (cont.)(as of 5/24/10) NumberPercent • Trials by Sponsor • US Federal (including NIH) 10,828 12% • Industry 29,233 32% • University, Other 50,076 55% • Total 90,137 • User Statistics • Page Views per month 70 Million • Unique visitors per month 950,000 16 16 16

  16. Screen shot of : Map of the World indicating number of studies with locations in that region. Patient - Volunteer 23% Researcher 14% Family/Friend 13% Patient - Learn 12% Provider 10% 9% Other 7% Trial Team Personnel 4% Student/Educator 3% Healthy Volunteer Investor 2% 1% Journalist 1% Healthcare Admin 1% Advocate ClinicalTrials.gov Visitors by “Role”(N=13,097) Source: American Customer Satisfaction Index (ASCI) Online Consumer Survey; Six-Month Period in 2007

  17. Sample Registry Record 18 18 18

  18. Screen shot of ClinicalTrials.gov showing Full Text View

  19. Screen shot of ClinicalTrials.gov showing Tabular View

  20. Screen shot of ClinicalTrials.gov showing archive

  21. Screen shot of MedlinePlus

  22. Screen shot of ClinicalTrials.gov number in The New England Journal of Medicine

  23. Screen shot of NLM Technical Bulletin article

  24. Screen shot of journal citation in PubMed highlighting Secondary Source ID

  25. Screen shot highlighting U.S. FDA Resources

  26. Screen shot highlighting Clinical Trials in U.S. FDA 510 (k) Premarket Notification

  27. Basic Results Database Basic Results Database 28

  28. Basic Results Reporting Requirements Results of FDA-approved/cleared products Generally, submission within 12 months of the earlier of estimated/actual primary completion date Delayed Submission of Results Seeking initial approval Seeking approval of a new use Extensions for “good cause” 29 29 29 29 29

  29. Basic Results Modules Participant Flow Baseline and Demographic Characteristics Outcome Measures Adverse Events (summary data) Other Information “Certain Agreements” Restricting Results Disclosure Overall Limitations and Caveats Results Point of Contact

  30. Sample Posted Results 31 31 31

  31. Screen shot of Clinical Trials Study Results

  32. Screen shot of Participant Flow: Overall Study Arms Milestone Reasons Not Completed 33

  33. Screen shot of Baseline Characteristics “Default” Required Measures User-Specified Measure Categories

  34. Screen shot of Outcome Measures 35

  35. Screen shot of Primary Outcomes Measure

  36. Screen shot of Measures Values and Statistical Analysis Statistical Analysis

  37. Screen shot of Serious Adverse Effects 38

  38. ICJME “…will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table.” [NOTE: Only about 23% of results records have associated publications at this time.] 39

  39. Uses of ClinicalTrials.gov

  40. For those concerned with human subjects protections… • Complete list of ongoing and completed trials of relevance • Assurance that information about the trial of interest • is in the public domain • for some trials, results will become public

  41. For those with medical conditions… • Finding a trial in which to participate • Finding an expanded access drug • Finding a center of research for a given condition/intervention

  42. For those concerned with human subjects protections… • Complete list of ongoing and completed trials of relevance • Assurance that information about the trial of interest • is in the public domain • for some trials, results will become public

  43. Screen shot of ClinicalTrials.gov Advanced Search 44 44

  44. Screen shot of ClinicalTrials.gov List Results 45

  45. For those concerned with research integrity… • Relatively complete list of trials • Description of protocol • Tracking of changes to protocols • Identifying all outcome measures • Providing results, regardless of journal publication status

  46. Screen shot of ClinicalTrials.gov Advanced Search

  47. Screen shot of ClinicalTrials.gov List Results

  48. For thoseseeking study results… • Linkages to PubMed • Summary Results in database • Results for all prespecified outcome measures • Standardized format facilitating comparisons

  49. Screen shot of ClinicalTrials.gov Advanced Search Outcome Measures = “Six Minute Walk” Age Group = “Child (birth-17)”