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The Difference Between Practice and Research – What the FDA Expects You to Understand Harvey M. Arbit, PharmD, MBA, RAC, CCRP University of Minnesota Director, IND/IDE Assistance Program,  Academic Health Center Adjunct Associate Professor, College of Pharmacy Phone 612-625-0930 Fax 612-625-3956 E-mail  [email_address] www.ahc.umn.edu/research/ind-ide/
Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Practice vs Research
Clinical Practice ≠ Clinical Research ,[object Object],[object Object],[object Object]
Clinical Investigation (Drug Research) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trials vs Medical Practice ,[object Object],[object Object],[object Object]
Practice of Medicine ,[object Object]
"Off-Label" Use of Marketed Drugs, Biologics and Medical Devices ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trial ,[object Object],[object Object],[object Object]
Investigational Use of Marketed Drugs, Biologics and Medical Devices   ,[object Object],[object Object],[object Object]
Investigational Use of Marketed Drugs, Biologics and Medical Devices (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Assessment Process ,[object Object],[object Object],[object Object],[object Object],[object Object]
 
Oncology Drugs ,[object Object],[object Object],[object Object]
Sponsor and Investigator
http://aapp.org/pdf/HansMayoPresentation.pdf
Sponsor 21 CFR 312.3(b) ,[object Object],[object Object]
Sponsor-Investigator   21 CFR 312.3(b) ,[object Object],[object Object],[object Object]
Form FDA 1571 ,[object Object]
When a sponsor signs the 1571  he/she agrees to the following: ,[object Object],[object Object],[object Object],[object Object],[object Object]
Responsibilities of  Sponsors  and Investigators   21 CFR 312 Subpart D ,[object Object],[object Object]
Investigator   21 CFR 312.3(b) ,[object Object]
Form FDA 1572 ,[object Object]
When an investigator signs the 1572 he/she commits to the following: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1572 (Cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Responsibilities of  Sponsors and  Investigators   21 CFR 312 Subpart D ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Good Clinical Practice (GCP)
 
 
Protocol elements for IND   21 CFR 312.23(a)(6)(iii) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Elements of a Clinical Trial Protocol   (GCP section 6) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Protocol Compliance It doesn’t matter who wrote the protocol – or whether the trial is funded by the DHHS or regulated by FDA –  NO change can be implemented without prior IRB approval  (except to mitigate immediate hazard).  The plan submitted to (and approved by) the IRB cannot be changed without approval. Some changes must also be submitted to the FDA.
Clinical Trial Monitoring
 
Proper Monitoring (FDA Guideline for the Monitoring of Clinical Investigations) ,[object Object],[object Object],[object Object],[object Object]
Purpose of Monitoring   (GCP section 5.18.1) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Site/Clinical Monitoring ,[object Object],[object Object],[object Object]
Focus of Monitoring Visits ,[object Object],[object Object],[object Object],[object Object],[object Object]
Data & Safety Monitoring Board (DSMB)
DSMB ,[object Object],[object Object],[object Object]
DSMB Composition ,[object Object],[object Object],[object Object],[object Object]
Data Safety Monitoring  GCP 5.5.2 ,[object Object],[object Object]
What FDA Looks For
What FDA Looks For ,[object Object],[object Object],[object Object],[object Object],[object Object]
What FDA Looks For (cont.) ,[object Object],[object Object],[object Object]
Regulatory Actions ,[object Object],[object Object],[object Object],[object Object],[object Object]
Summary –  Points of Importance ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Are there any Questions ? Thank you !

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The difference between practice and research 111607