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Bedside Research: Protocol Development for Investigational New Drug Applications at CHOP
Zenobia CoferResearch Administration Fellowship
January 20, 2015
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
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
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
*
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.
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
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 OfficeDirect Fellowship Supervisor: Deanna DiDonato
NICU
GI&Nutrition
Protocol Development using team dynamics
Investigator• current treatment • benefits of new treatment• potential risks associated with treatmentIND/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
PhD skills relevant for Protocol Development
• Relevant literature reviewsPUBMEDEndNote or RefWorks
• Writing skillsSuccinctly, but accurately
• Can offer advice on study designTraining based on performing experiments
• Facilitate communication within the team
NICU Interventional Protocol1. Complied reference list• Original protocol had a minimal amount of citations• No citations were after 20062. Wrote up background information for protocol3. Suggested justification for study design based on previous literature4. Participated in regular meetings with NICU investigators
Protocol Dev. IND/IDE SRCIRB
FDA Start
Protocol Dev. IND/IDE SRCIRB
FDA Start
Protocol Dev. IND/IDE SRCIRB
FDA StartNICU
NICU
NICU
Project Progress over Research Administration Fellowship Term
Aug 2014
Nov 2014
Jan 2015
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
Future Directions
Protocol Dev. IND/IDE SRCIRB
FDA StartNICUJan 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
Acknowledgements
Office of Postdoctoral Affairs and Research Training
Clinical Research and Support OfficeDeanna DiDonato
Questions?
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