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Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
Webinar: Clinical Trial Registration Jan 2009
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Webinar: Clinical Trial Registration Jan 2009

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Webinar on Clinical Trial Registration process in the US, Delivered on Jan 27, 2009

Webinar on Clinical Trial Registration process in the US, Delivered on Jan 27, 2009

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  • 1. <ul><li>A Product Development Services Company </li></ul><ul><li>From Lab to Market Approval </li></ul><ul><li>Regulatory Strategy </li></ul><ul><li>Strategy Implementation </li></ul><ul><li>Pre-Clinical Assays </li></ul><ul><li>Global Clinical Trials </li></ul><ul><li>Global Regulatory Submissions </li></ul><ul><li>Contact: Patrick Burke at [email_address] </li></ul><ul><li>301-528-7000 </li></ul>Amarex Clinical Research Washington DC metro area
  • 2. <ul><li>Thank you! </li></ul><ul><li>Goal of these Seminars </li></ul><ul><li>Information sharing </li></ul><ul><li>Professional Development </li></ul><ul><li>Networking </li></ul>
  • 3. Applicable Clinical Trials for Clinical Trial Registration www.clinicaltrials.gov Mukesh Kumar, PhD, RAC Senior Director, Regulatory Affairs Amarex Clinical Research Germantown, MD 20874, USA Tel: 001-240-750-4893 Email: [email_address]
  • 4. “ Applicability” of the Law <ul><li>Confusion about certain(!) trials </li></ul><ul><ul><li>Registration before trial initiation </li></ul></ul><ul><ul><li>Bioequivalence studies (ANDA) </li></ul></ul><ul><ul><li>IND/IDE studies </li></ul></ul><ul><ul><li>505(b)(2) applications </li></ul></ul><ul><ul><li>Amendments to applications </li></ul></ul><ul><ul><ul><li>Protocol amendments </li></ul></ul></ul><ul><ul><ul><li>Information amendments (CMC, Pharm-tox, etc) </li></ul></ul></ul><ul><ul><li>Foreign clinical trials </li></ul></ul><ul><ul><li>Enforcement </li></ul></ul>
  • 5. History of Clinical Trial Registration <ul><li>FDA Modernization Act 1997 </li></ul><ul><ul><li>Section 113 instructed the NIH to establish a clinical trial database </li></ul></ul><ul><ul><ul><li>Serious and life-threatening conditions </li></ul></ul></ul><ul><ul><ul><li>Only drugs and biologics (not devices) </li></ul></ul></ul><ul><ul><ul><li>Purpose, eligibility, location and contact </li></ul></ul></ul><ul><ul><li>First version in Feb 2000 </li></ul></ul><ul><ul><li>Final Guidance in March 2002 </li></ul></ul><ul><ul><li>Not mandatory , no penalties for non-compliance </li></ul></ul><ul><ul><ul><li>Within 21 days of first subject enrollment </li></ul></ul></ul>
  • 6. The Process for Registration <ul><li>Set up an account on Protocol Registration System http://prsinfo.clinicaltrials.gov/ </li></ul><ul><ul><li>Organization account: Many trials </li></ul></ul><ul><ul><li>Individual account: individual investigator </li></ul></ul><ul><li>Enter Trial information </li></ul><ul><ul><li>http://prsinfo.clinicaltrials.gov/definitions.html </li></ul></ul><ul><ul><li>Within 21 days of first subject enrollment </li></ul></ul><ul><li>Update information as applicable </li></ul>
  • 7. International Committee of Medical Journal Editors (ICMJE) <ul><li>Declared in 2004 that it will not accept publications for non-registered clinical trials </li></ul><ul><ul><li>Based on discussions with WHO </li></ul></ul><ul><ul><li>To increase patient access of clinical trial information </li></ul></ul><ul><ul><li>Establish a world-wide standard for trial registration </li></ul></ul><ul><li>Lead to Fair Access to Clinical Trials (FACT) Act proposed in the US Congress in June 2005 </li></ul>
  • 8. International Committee of Medical Journal Editors (ICMJE) Minimal Registration Dataset Item Comment 1. Unique trial number 2. Trial registration date 3. Secondary IDs 4. Funding source(s) Name of the organization(s) that provided funding for the study. 5. Primary sponsor 6. Secondary sponsor(s) 7. Responsible contact person Public contact person for the trial, for patients interested in participating. 8. Research contact person Person to contact for scientific inquiries about the trial. 9. Title of the study Brief title chosen by the research group (can be omitted if the researchers wish). 10. Official scientific title of the study This title must include the name of the intervention, the condition being studied, and the outcome 11. Research ethics review Has the study at the time of registration received appropriate ethics committee approval (yes/no)?
  • 9. International Committee of Medical Journal Editors (ICMJE) Minimal Registration Dataset Item Comment 12. Condition The medical condition being studied 13. Intervention(s) A description of the study and comparison/control intervention(s) 14. Key inclusion and exclusion criteria Key patient characteristics that determine eligibility for participation in the study. 15. Study type Randomized vs. non-randomized, type of masking (e.g., double-blind, single-blind), type of controls (e.g., placebo, active), and group assignment, (e.g., parallel, crossover, factorial). 16. Anticipated trial start date Estimated enrollment date of the first participant. 17. Target sample size The total number of subjects the investigators plan to enroll before closing the trial to new participants. 18. Recruitment status Is this information available (yes/no) (If yes, link to information). 19. Primary outcome The primary outcome that the study was designed to evaluate Description should include the time at which the outcome is measured (e.g., blood pressure at 12 months) 20. Key secondary outcomes The secondary outcomes specified in the protocol. Description should include time of measurement (e.g., creatinine clearance at 6 months).
  • 10. FDA Amendment Act (FDAAA) 2007 <ul><li>All Applicable Clinical trials must be registered by sponsors (responsible party) </li></ul><ul><li>Expanded data elements </li></ul><ul><li>Must be done by 26 Dec 2007 </li></ul><ul><li>Certification of compliance to accompany “Applicable” trial submissions to FDA </li></ul><ul><li>Submit trial results upon study completion </li></ul><ul><li>Severe penalties for non-compliance </li></ul><ul><ul><li>$10,000 plus $10,000/day till the violation is corrected </li></ul></ul>
  • 11. The Process for Registration <ul><li>Set up an account on Protocol Registration System http://prsinfo.clinicaltrials.gov/ </li></ul><ul><ul><li>Organization account: Many trials </li></ul></ul><ul><ul><li>Individual account: individual investigator </li></ul></ul><ul><li>Enter Trial information </li></ul><ul><ul><li>http://prsinfo.clinicaltrials.gov/definitions.html * (Aug 20, 2008) </li></ul></ul><ul><ul><li>Before IND submission </li></ul></ul><ul><li>Update information as applicable </li></ul><ul><li>Enter trial results </li></ul><ul><ul><li>http://prsinfo.clinicaltrials.gov/results_definitions.html ** </li></ul></ul><ul><ul><li>(Jan 9, 2009) </li></ul></ul><ul><ul><li>Within 1 year of completion of trial </li></ul></ul><ul><ul><li>Extension provided on a case-by-case basis with written request and certification </li></ul></ul>
  • 12. Compliance Certification <ul><li>Form FDA 3674 </li></ul><ul><ul><li>Certify that either </li></ul></ul><ul><ul><ul><li>not applicable due to </li></ul></ul></ul><ul><ul><ul><ul><li>No clinical trials </li></ul></ul></ul></ul><ul><ul><ul><ul><li>No “applicable” clinical trials </li></ul></ul></ul></ul><ul><ul><ul><li>Applicable </li></ul></ul></ul><ul><ul><ul><ul><li>Provide Registration Number obtained from Clinicaltrials.gov </li></ul></ul></ul></ul><ul><ul><li>Declare that the sponsor is </li></ul></ul><ul><ul><ul><li>Aware of the law </li></ul></ul></ul><ul><ul><ul><li>the information is accurate </li></ul></ul></ul><ul><ul><ul><li>there are no false statements </li></ul></ul></ul>
  • 13. Initial Developments and Confusion <ul><li>Dec 12, 2007: Emergency release of Form FDA 3674 </li></ul><ul><ul><li>Compliance should take about 45 min </li></ul></ul><ul><li>March 5, 2008: First draft guidance </li></ul><ul><li>May 21, 2008 Guidance on reporting results (Basic Results) </li></ul><ul><li>August 25, 2008: FDA published response to its March notice (IND trials) </li></ul><ul><li>December 8, 2008: Draft description of “Applicable” clinical trials: Bioequivalence studies </li></ul><ul><li>Jan 21, 2009: Final Guidance </li></ul>
  • 14. Applicable Clinical Trials <ul><li>A clinical trial meeting the following four criteria </li></ul><ul><li>Using a drug, biologic or device requiring FDA approval for investigation and sale </li></ul><ul><li>Clinical investigation according to a study protocol </li></ul><ul><li>Controlled clinical trial </li></ul><ul><ul><li>Placebo-controlled </li></ul></ul><ul><ul><li>Dose-comparison </li></ul></ul><ul><ul><li>Blinded </li></ul></ul><ul><ul><li>No intervention or active intervention </li></ul></ul><ul><ul><li>Historical control </li></ul></ul><ul><li>Other than Phase 1, feasibility, pilot or prototype-testing trial </li></ul>
  • 15. Current Understanding <ul><li>Covered trials: </li></ul><ul><li>INDs and new protocol submissions to existing INDs </li></ul><ul><li>NDAs and efficacy supplements to approved NDAs </li></ul><ul><li>BLAs and efficacy supplements to approved BLAs </li></ul><ul><li>Abbreviated new drug applications (ANDAs) </li></ul><ul><li>Premarket approval applications (PMAs) </li></ul><ul><li>PMA panel track supplements </li></ul><ul><li>Humanitarian device exemptions (HDEs) </li></ul><ul><li>510(k)s that refer to or include information on a clinical trial </li></ul>
  • 16. Current Understanding <ul><li>Exempt applications: </li></ul><ul><li>CMC amendments to INDs, NDAs and BLAs </li></ul><ul><li>Non-clinical pharmacology/toxicology amendments to INDs, NDAs and BLAs </li></ul><ul><li>Single Patient INDs </li></ul><ul><li>ANDA amendments and supplements that contain no in-vivo bioequivalence information </li></ul><ul><li>ANDA, BLA, and NDA promotional materials </li></ul><ul><li>IND, BLA and NDA Safety Reports </li></ul><ul><li>ANDA, BLA, NDA, HDE, and PMA mandatory and voluntary adverse event or medical device reports </li></ul><ul><li>FDA Meeting requests </li></ul><ul><li>510(k)s that contain no clinical data </li></ul>
  • 17. Foreign Clinical Trials <ul><li>Covered only if: </li></ul><ul><ul><li>Done under a US IND </li></ul></ul><ul><ul><li>Drug/device manufactured in the US </li></ul></ul><ul><ul><li>Have US sites (will have a US IND) </li></ul></ul><ul><ul><li>Used to support a US marketing approval application </li></ul></ul><ul><ul><li>Completed after Dec 26, 2007 </li></ul></ul>
  • 18. Foreign Clinical Trials <ul><li>Three options in FDA 3674 </li></ul><ul><ul><li>A. I certify that the requirements do not apply because the application/submission which this certification accompanies does not reference any clinical trial. </li></ul></ul><ul><ul><li>B. I certify that the requirements do not apply to any clinical trial referenced in the application/submission which this certification accompanies. </li></ul></ul><ul><ul><li>C. I certify that the requirements apply to one or more of the clinical trials referenced in the application/submission which this certification accompanies and that those requirements have been met. </li></ul></ul>
  • 19. “ Applicability” of the Law <ul><ul><li>Registration before trial initiation </li></ul></ul><ul><ul><li>Bioequivalence studies (ANDA) </li></ul></ul><ul><ul><li>IND/IDE studies </li></ul></ul><ul><ul><li>Foreign clinical trials </li></ul></ul><ul><ul><li>505(b)(2) applications </li></ul></ul><ul><ul><li>Amendments to applications </li></ul></ul><ul><ul><ul><li>Protocol amendments </li></ul></ul></ul><ul><ul><ul><li>Information amendments (CMC, Pharm-tox, etc) </li></ul></ul></ul><ul><ul><li>Enforcement </li></ul></ul><ul><ul><ul><li>Case by case, for now </li></ul></ul></ul><ul><ul><ul><li>Avoid by discussing at the meetings </li></ul></ul></ul>
  • 20. Best Practices <ul><li>Register trials on Clinicaltrials.gov </li></ul><ul><ul><li>Easy process: less than an hour to comply </li></ul></ul><ul><ul><li>Simple one page certification form, easy account set-up </li></ul></ul><ul><ul><li>Does not need IRB/FDA pre-approval </li></ul></ul><ul><ul><li>Easy to update, single user, non-technical </li></ul></ul><ul><ul><li>Similar processes world-wide </li></ul></ul><ul><ul><li>Free </li></ul></ul><ul><li>Foreign trials: If you ever want to think about US market… register now </li></ul>
  • 21. Thank You! Questions and Comments Mukesh Kumar, PhD, RAC Senior Director, Regulatory Affairs Amarex Clinical Research Germantown, MD 20874, USA Tel: 001-240-750-4893 Email: [email_address]

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