Bedside Research
- 1. Bedside Research: Protocol Development for Investigational New Drug Applications at CHOP Zenobia Cofer Research Administration Fellowship January 20, 2015
- 3. Investigational New Drug • a drug that has not been to the marketplace • previously marketed drug being studied for an additional indication • A previously marketed drug being studied in a in a new or special population
- 4. Federal Drug Administration • Federal Drug Administration (FDA) requires persons/entities (sponsor) submit an IND application prior to administering an IND to humans • Sponsors can be drug companies, a cooperative group, or individual physicians. • If FDA approves IND application, study cannot proceed without institutional approval
- 5. Timeline of Institutional and Federal Regulatory Review Before Trial Start Protocol Dev. IND/IDE SRC IRB FDA Start 1-3 months 1 month 1 month •Ideal timeframe 3-6 months •Protocol can be stalled at any of regulatory steps •Contact CRSO and/or institutional committees for assistance Institutional Federal
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- 7. Keys of good protocol • Gives reviewers background information regarding the condition or target population • Addresses current medical treatment and continued problems with available treatment • Justifies the use of a new drug/device to address continued deficits in treatment • Presents a well developed targeted plan to investigate the drug in target population • Requires time to develop Protocol Dev.
- 8. FDA requirements for IND Protocol • Drug toxicity • Previous research (animal and clinical) • Drug manufacturing • Sponsor research plan • If FDA approves the protocol, it can still be stalled by the IRB
- 9. Fellowship Projects Purpose: Aid in protocol development • Descriptive/Observational Study (NICU) • Intervestigational Study I (NICU) • Intervestigational Study II (GI&Nutrition): biological • Develop IND Protocol Template for Investigators Clinical Research Support Office Direct Fellowship Supervisor: Deanna DiDonato
- 11. Protocol Development using team dynamics Investigator • current treatment • benefits of new treatment • potential risks associated with treatment IND/IDE Program Manager • institutional and federal regulatory requirements • advises investigator on regulatory obligations • facilitates communication between different regulatory bodies and investigators Research Admin Fellow • provide questions regarding methodology • provide input on scientific design Investigator IND/IDE Program Manager Research Admin Fellow/PhD
- 12. PhD skills relevant for Protocol Development • Relevant literature reviews PUBMED EndNote or RefWorks • Writing skills Succinctly, but accurately • Can offer advice on study design Training based on performing experiments • Facilitate communication within the team
- 13. NICU Interventional Protocol 1. Complied reference list • Original protocol had a minimal amount of citations • No citations were after 2006 2. Wrote up background information for protocol 3. Suggested justification for study design based on previous literature 4. Participated in regular meetings with NICU investigators
- 14. Protocol Dev. IND/IDE SRC IRB FDA Start Protocol Dev. IND/IDE SRC IRB FDA Start Protocol Dev. IND/IDE SRC IRB FDA Start NICU NICU NICU Project Progress over Research Administration Fellowship Term Aug 2014 Nov 2014 Jan 2015
- 15. SRC Review of NICU protocol • Advised investigators to justify target population for study • Wanted investigators to justify statistical analysis • Team had a meeting with SRC chair • SRC thought background section was well written
- 16. Future Directions Protocol Dev. IND/IDE SRC IRB FDA Start NICUJan 2015 NICU Interventional Protocol •Resubmit to the SRC in February •Prepare concurrent submissions to the FDA and CHOP IRB •Start trial in May 2015 NICU Descriptive Protocol •Submission to IRB
- 17. Acknowledgements Office of Postdoctoral Affairs and Research Training Clinical Research and Support Office Deanna DiDonato
- 18. Questions?