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FDA AA - Title VIII Clinical Trial Databases Friday, 30 November 2007 MBC Sarah Doyle Larson Program Manager, Biomedical Regulatory Affairs Compliance
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2 Agenda Title VIII Overview Timelines Clinical Trial Registry Clinical Trial Results Database Other Provisions Other Non-FDA Influences to Consider State of Maine WHO ICMJE Trade Associations International Regulations and Standards
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3 What is Title VIII? Definitions Registry = Protocol parameters for ongoing trials Results Database = Results data from completed trials Title VIII Mandates the expansion of www.ClinicalTrials.gov to form a Clinical Trials Registry and Results Database www.ClinicalTrials.gov Broader scope of trials that must be registered Increases the amount of data elements required in each posting Requires submission of clinical trial results data Penalties for noncompliance Several “other” requirements Implementation is a “phased” approach Timelines for complying range from Dec. 26, 2007 to Sep. 27, 2010
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4 FDA/NIH Implementation Timeline 1 Sept 27 2007 Congress Passes Law 90 Days (12/26/07) Linking to FDA and NIH information Expanded registry data elements Expanded registry scope 20082009 2010 1 Year (9/27/08) Basic results reporting Expanded registry scope 18 months (3/27/09) Public meeting to discuss expanded registry and results database Adverse events (if by rulemaking) 3 years (9/27/2010) Expansion of registry and results database by rulemaking 2 Years (9/27/09) Adverse events (if by default) 1 Timeline provided by Terry Toigo, Director, FDA Office of Special Health Issues, 27 Nov 2007
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5 Clinical Trial Registry
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6 Expanded Registry Data Bank – 26 Dec 2007 Scope of trials expanded beyond FDAMA §113 Drug/Biologics: All controlled clinical investigations, other than Ph. 1 Devices: All controlled trials with health outcomes; excludes small feasibility studies; includes pediatric postmarket surveillance Additional Information Required: Some previously optional fields are now mandatory New data elements Links to “results” information to be provided by FDA / NIH Maintaining Postings: Updates – at least once/every 12 months Recruitment Status – w/in 30 days of change Penalties for Noncompliance and Public Notices NIH Implementation & Compliance: 90 Days (26 Dec 2007)
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7 Newly initiated applicable trials: register by later of: 26 Dec 2007 -OR- 21 days > 1 st pt enrolled “Ongoing” applicable trials as of 27 Sep 2007 that are not “completed” by 26 Dec 2007 … if SLT = “yes”, update posting to include all req’d fields by: 26 Dec 2007 if SLT = “no”, update posting to include all req’d fields by: 27 Sep 2008 Notes regarding NIH “posting” dates: Drugs OR approved/cleared Devices w/in 30 days of receipt Devices not previously approved/cleared “held” for release until approved; then released w/in 30 days of approval Expanded Registry Data Bank – When to Register?
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8 Clinical Trial Results Data Bank Results Links Basic Results Expanded Results Data Bank
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9 Scope: Approved Drug, Biologics, Devices CTs that form basis for efficacy claim or CTs conducted > approval FDA Information to be posted (Links): Advisory Committee Meetings FDA assessment of results for pediatric trials (Sec 505A/B) FDA public health advisories FDA drug “action package” for approval documents FDA device PMA or 510(k) summary of safety/efficacy NIH Information to be posted (Links): Medline citations Label Implementation Timeline: “Beginning” 26 Dec 2007 Responsibility of FDA/NIH For applicable trials ongoing as of 27 Sep 2007, link 30 days > approval and w/in 30 days of results becoming public For other trials posted prior to 27 Sep 2007: as available Results Data Bank “Links” – 26 Dec 2007
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10 Scope: Approved Drugs, Biologics, Devices Includes applicable trials completed per protocol & terminated trials Information to be posted: Demographics & baseline characteristics of patient sample Primary & Secondary Outcomes Point of Contact Certain Agreements Implementation Timeline: 27 Sep 2008 In general, submit w/in 12 mos of completion date (estimated or actual) Completion Date = LPLV Delayed submission w/ certification: Initial approval: Submit results w/in 30 days of initial approval/clearance New use: Submit results w/in 30 days of Approval/clearance of new use Issuance of letter by FDA (e.g. complete response, not approving/clearing, not approvable) Withdrawal w/out resubmission after 210 days Limit if no action: 2 years Results Data Bank “Basic Results”– 27 Sep 2008
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11 Public meeting to be held by 27 Mar 2009 Rulemaking for AE Reporting by 27 Mar 2009 (or default provision will apply on 27 Sep 2009) Rulemaking for Expansion of Data Bank by 27 Sep 2010: Scope: Trials w/ completion date on or > Sept 1997 for approved products May include unapproved products (whether approval was sought or not) Information and format to be posted: Non-technical & technical summaries of results (non promotional) Protocol or other info needed to “evaluate” completeness of results “Other categories as determined to be appropriate” by FDA Results Submittal Timeline – extend from 12 mos to 18 mos? How to address trials where results were posted < data bank “Expansion”? Implement QC Procedures Consider WHO Data Set Results Data Bank “Expanded Data Bank” 27 Sep 2010
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12 Other Provisions
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13 Certification w/ all submission - 27 Dec 2007 State Preemption – 27 Dec 2010 Modify ICF Public Notice of Noncompliance; Penalties Guidance to be issued re: how requirements apply to a pediatric postmarket surveillance Voluntary submissions acceptable QC Pilot Program confirm completeness, accuracy, and ensure non-promotional Consult w/ experts on risk communication Waiver process for “extraordinary circumstances” when protecting public health or national security Other Provisions in Title VIII
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14 Other non-FDA influences to consider
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15 US States: Maine - passed March 2007; FDAAA preemption effective 27 Sep 2010 Other State activity in 2007 WHO: Policy: registration & results of ALL human subject trials WHO Primary Registers WHO data elements ICMJE – WHO data elements Require prospective registration of “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome” As of July 2008, will no longer exclude Phase I Ingelfinger Rule / Post results abstract <300 words if pub is pending Trade Associations PhRMA - joint position statement Jan 2005 BIO - Principles on Clinical Trials Advamed Other Considerations
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16 Varying International Standards Mandatory Israel (clinicaltrials.gov) Italy (local language; country specific EUDRACT posting) South Africa (country specific) Taiwan Proposed France (local language; requirements similar to Italy) Voluntary Australia (country specific website) China (country specific website) Germany India (country specific website) Japan (country specific website) Netherlands Spain UK (country specific website) Local IRB/EC requirements
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17 Summary New FDAAA requirements begin 26 Dec 2007 and will continue through 27 Sep 2010 FDA / NIH is still in the process of implementing … Stay tuned! http://www.clinicaltrials.gov http://prsinfo.clinicaltrials.gov In some cases, the NIH’s timeline for implementation allows little time to update internal SOPs and/or to complete tasks as required. Rulemaking! Lack of harmonization between FDAAA and other “influences”
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18 Questions? Sarah.Larson@Genzyme.com
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