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Why did the FDA Release a Guidance for Conducting Clinical Trials at Clinics?
(Thursday, September 26, 2024) Clinical trials are run at clinics with patients, that’s how it has been for the last. So, the new FDA guidance on how to run trials at clinics may come as a surprise to many doing such trials for the last few decades. Doctors act as investigators and patients become subjects at the same location. So, we were scratching our heads to understand what was new in this guidance. We found little. The guidance describes practices that may appear routine common sense approaches followed at clinics participating in clinical trials. The sponsor is responsible for selecting suitably qualified doctors to be investigators in their trials and the doctor/investigator must follow the clinical protocol. The clinical protocol asks for activities that are not generally a part of the routine clinical practice but are needed to generate data for the clinical trial. The care provided to the subjects in clinical trials is different from what would be provided in routine care. Other doctors, not directly participating in the clinical trials could be sub-investigators working under the supervision of the principal investigator and could also play ancillary roles such as referring patients, collecting routine data, filling electronic health records, and performing routine medical procedures in support of the trial. There is nothing we could find in the guidance that is not already covered in the training of the clinics wanting to participate in clinical trials if not already, contracts and monitoring practices. One could imagine sponsor-investigator and research trials where the parties involved in running a trial may not be aware of these practices but the guidance does not refer to that. If you find something new, please write back to us. The guidance document is at best a good primer for new investigators and new sponsors. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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