We currently have an IND, but from researching most observational studies seem to be post market and do not require an IND. I was not sure if we would amend the IND to add this observational study protocol or if registering on clinicaltrials.gov was sufficient. I am leaning towards amending the IND but I wanted to get other RA professionals input.
Thanks for your help..
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Brett Snyder, RAC, CQA
Regulatory Affairs Manager
Cook MyoSite, Inc.
Pittsburgh, PA
USA
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Original Message:
Sent: 25-Mar-2021 11:14
From: Narayan Rao
Subject: Observation Study for biologic
Please clarify, if you are already in phase 3, how can there not be an IND already? If you already have an IND then I would conduct this study under the same IND.
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GRSAOnline
Original Message:
Sent: 25-Mar-2021 10:48
From: Brett Snyder
Subject: Observation Study for biologic
Hello -
My company is starting to plan an observation study for a pre-market biologic. We are currently in Phase 3 trials and would like to enroll previously-exposed trial participants into an observational study to gather long-term safety data.
Would this observational study need an IND or would it only be listed on clinicaltrials.gov and approved through the applicable IRBs? Any input would be appreciated.
Thank you!
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Brett Snyder, RAC, CQA
Regulatory Affairs Manager
Cook MyoSite, Inc.
Pittsburgh, PA
USA
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