1 / 35

Session 2 Expanded Clinical Trials Registry Deborah A. Zarin, M.D.

Session 2 Expanded Clinical Trials Registry Deborah A. Zarin, M.D. NLM Accomplishments Impact to Date Specific Data Element Issues. Pilot Quality Control Project Recommendation to Secretary – Narrative Summaries. Expanded Clinical Trial Registry. REGISTRY. New Administration

dana
Download Presentation

Session 2 Expanded Clinical Trials Registry Deborah A. Zarin, M.D.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Session 2Expanded Clinical Trials RegistryDeborah A. Zarin, M.D. NLM Accomplishments Impact to Date Specific Data Element Issues

  2. Pilot Quality Control Project • Recommendation to Secretary – Narrative Summaries Expanded Clinical Trial Registry REGISTRY New Administration Transition Phase Public Meeting 9/27/07 12/26/07 9/27/08 3/27/09 9/27/10 90 d 1 yr 18 m 2 yr 3 yr Enactment Expansion by Rulemaking: Final Rule Additional Adverse Events Data RESULTS Launch Basic Results Database Linking to existing results information at FDA and NIH

  3. Accomplishments To Date • ClinicalTrials.gov registration system (PRS) modified to enable compliance with expanded registration requirements (11/27/07) • Links established from registry to NIH/NLM and FDA results information • Information developed for affected communities • NLM Data Element Definitions and Fact Sheet • NIH Guide Notices (2) and FAQs – including instructions for initial NIH grantee/contractor compliance

  4. Enforceability of Data Elements • Need to collect information not explicitly listed in the law • More detail required than specified in law (e.g., “study design”) • Additional information necessary to comply with law (e.g, data required to implement search requirements) • Competing concerns • Congressional intent to establish registry quickly • Difficulty of enforcing all necessary data elements without regulation • HHS is considering rulemaking

  5. Revisions to Registry • “Data providers” are alerted to items that (may be) required by the FDAAA • Omission of these items does not block acceptance of the record, and an NCT # is assigned • Items in question include those with some complexity, those that are required to implement the law, and one that reflects NIH policy • HHS is considering rulemaking

  6. Study Record

  7. New Records: 2007 vs. 2006 ~45% New Accounts: 2007vs. 2006 Sept Oct Nov Dec

  8. Enhanced Registry Activity (12/1/07-1/20/08) • NewStudy Submissions: 2,932 • 419 records/week • UpdatedStudies: 10,558 • 1,508 records/week • Overall Studies: 13,490 • 1,927 records/week; 100% increase • New PRS Accounts: 252 • 36/week; 64% increase • Current Backlog: ~600 records (~10 days)

  9. Overall Characteristics: New Studies (12/1/07-1/20/08) Total 2,932 (100%) Type of Trial* Observational 628 (22%) Interventional 2,281 (78%) - Drug, Biologic 1,492 - Behavioral, Gene Transfer, Other 479 - Medical Procedure 290 - Device 227 (+27 delayed posting) * 23 records missing “Study Types” information

  10. Overall Characteristics: New Studies (12/1/07-1/20/08) Total – Interventional Studies 2,281 (100%) Studies by Registrant Type University, Other 1,397 (61%) Industry 645 (28%) US Federal (including NIH) 239 (11%) Studies by Facility Location US sites only 1,436 (63%) Non-US only 569 (25%) US & non-US mixed 73 ( 3%) Missing 203 ( 9%)

  11. Overall Characteristics: Updated Studies(12/1/07-1/20/08) Total 10,558 (100%) Type of Trial* Observational 1,019 (10%) Interventional 9,535 (90%) - Drug, Biologic 8,080 - Behavioral, Gene Transfer, Other 776 - Medical Procedure 4,282 - Device 329 *4 records missing “Study Types” information

  12. Overall Characteristics: Updated Studies(12/1/07-1/20/08) Total – Interventional Studies 9,535 (100%) Studies by Registrant Type University, Other 1,947 (21%) Industry 2,997 (31%) US Federal (including NIH) 4,591 (48%) Studies by Facility Location US sites only 5,746 (60%) Non-US only 2,006 (21%) US & non-US mixed 1,158 (12%) Missing 625 ( 7%)

  13. Delayed Posting of Device Trial Registrations • Law appears to prohibit public posting of trials of devices that have not been approved/cleared by FDA –even whendesired by registrant • Would therefore: • Require removal from current database of some device trials voluntarily posted prior to passage of law • Preclude use of ClinicalTrials.gov for recruitment • Preclude use of ClinicalTrials.gov to comply with registration policy of journal editors (ICMJE) • Limit transparency of such trials funded by NIH or other gov’t agencies • Complaints received from some companies; some registrants are omitting approval/clearance status of devices to circumvent • HHS is studying possible options

  14. Device Studies:Delayed Posting • Must answer “yes” to following: Indicate whether this is an unapproved or uncleared device trial for which posting to ClinicalTrials.gov should be delayed in accordance with US Public Law 110-85, Title VIII, Section 801. • 32 studies in “lock box” as of 2/7/08

  15. Overall Interventional Device Studies (12/1/07-1/20/08)

  16. Delayed Posting General Characteristics Total: 32 studies (as of 2/7/08) Provider Type 27 Industry 5 Other Study Type 27 Interventional 4 Expanded Access 1 Observational

  17. Analysis of Response:OVERALL Data Completion Statistics forOverallActive Phase II-IV Drug/Device Interventional Trials Submitted(12/1/07 - 1/20/08)

  18. Top Device Companies * Source: Not so Lonely at the Top. Medical Product Outsourcing (MPO), July/August 2007 **All device interventional and observational studies registered at ClinicalTrials.gov as of 2/4/08 ***Active, phase II-IV device interventional trials ****Includes: BiosenseWebster, ConorMedsystems, Cordis, Dupuy*, Ensure, Ethicon*, LifeScan, Visioncareinc

  19. Top Pharmaceutical Companies * Source: Top 10 Companies by U.S. Sales. IMS Health, IMS National Sales Perspective.3/2007 ** All interventional and observational studies registered at ClinicalTrials.gov as of 2/4/08 *** Active, phase II-IV drug/biologic interventional trials

  20. Specific Data Element Issues Public Law 110-85, Section 801 PL 110-85 Implementation NIH Policy

  21. Evolution of Data Elements • ClinicalTrials.gov has included data elements necessary to accommodate many policies • FDAMA • ICMJE • Specific wording and structure of data elements has evolved with experience • FDAAA has incorporated previously optional ICMJE data elements—usually identified by overall title (without details)

  22. NIH Policy – “Board Approval” • Submitted studies should have approval from a human subjects review board prior to the recruitment of the first patient • Studies may be registered prior to board approval, if status is “Not yet recruiting” • Data Elements • Board Approval Status (e.g., “Submitted, exempt”) • Board Name • Board Affiliation • Board Contact

  23. Interventional “Study Design” • Each of the following elements is required • Intervention Model – intervention assignments (e.g., parallel arms) • Number of Arms – number of comparative groups • Masking – knowledge of intervention assignments (e.g., double blind) • Allocation – participant assignment to intervention arm (e.g., randomized) • Sources: ICH E3, 21 CFR 314.126

  24. “Intervention Name” • Provides sufficiently detailed description of the intervention(s) and to link intervention(s) to arm(s) • Data Elements • Intervention Name: generic name for drugs; for others, sufficient detail to distinguish from similar interventions (e.g., devices) • Intervention Description: e.g., dosage • Arm Name or Label: way to identify arm • Arm Type: e.g., experimental, active comparator • Arm Description: if different from intervention description

  25. ENHANCE TrialNCT00552097

  26. CATIENCT00014001

  27. “Outcome Measure” • Specific measurement that will be used to measure the effect of experimental variables in a study • Requires the following • Outcome Measure: Description of the specific measure • Outcome Time Frame: Time point(s) at which outcome measure is assessed • [Safety Issue? (yes/no)]

  28. PL 110-85 Implementation • Safety Issue? – “the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome” • Facility Contact – location information (e.g., city, state, country) to be able to search by “location of the clinical trial” • Applicable Clinical Trial? • FDA Regulated Intervention? (Yes/No) • Section 801 Clinical Trial? (Yes/No) • Delayed Posting? (Yes/No)

  29. Other Questions to Address • Cut-off for modifying registry records? • Estimated completion date • Outcome measures • Target enrollment • Good enough outcome measure? • How should changes be displayed?

More Related