I am working with a sponsor who has submitted a sponsored clinical trial to the FDA. The FDA has reviewed the protocol a few times. The sponsor and investigator have collaborated on the protocol. This study is not on a pathway for an NDA, the sponsor has a separate IND/NDA they are working on to get their drug to market. The investigator is getting funding from a separate group, the sponsor is only providing work on the back end for data, monitoring, etc. Note the drug is not approved.
The sponsor no longer has the resources for providing work on the back end for this study. As this does not truly seem like a sponsored trial anyway (as the sponsor is not putting up cash for it and it is not a study needed for the IND/NDA/drug approval), the sponsor is thinking of backing out of sponsorship. If so, the sponsor would then sign an external collaborative research agreement with the site, and the site itself would become the sponsor and submit their own IND.
We received some internal feedback that the sponsor cannot walk back on sponsorship once the FDA has seen this. There is concern that issues would arrive at the FDA that the same PI listed on the potentially cancelled sponsor study, would be the same PI listed on the new investigator IND, and the studies would be identical. There is also feedback this may affect the sponsor's NDA submission, but I don't see a problem there as this study is not required at all for the NDA. I don't see what is wrong with the sponsor cancelling the study and having the investigator re-submit their own IND.
I appreciate any feedback here. Truly and warmly :)
Nothing wrong if the Investigator submits his own IND and pursue the study if the sponsor authorizes in an agreement since the sponsor owns the drug. Your proposal is reasonable from RA perspective and these things happen all the time both at big pharma and the small emerging companies. Reach out privately if you have any further questions!
Honestly, you need to hire an experienced RA professional. Who ever said this to you is totally incorrect! There is nothing wrong if the sponsor decides to end the study and authorize the Investigator pursue the study under his/her own IND.
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