We have a situation where there is a sponsored ongoing drug study (currently enrolling) that is not needed for the NDA. The sponsor can no longer fund or provide monitoring, etc. for the study.
The study needs to go from a sponsored study to an investigator-initiated trial. Can you transfer the sponsorship from the sponsor to the institution? Or would the sponsor need to withdraw the study and the investigator submit their own IND?
I know this is possible from sponsored study to sponsored study, or investigator-initiated trial to investigator-initiated trial, but I was unsure about switching sponsorship from a sponsored study to an investigator-initiated study.
Thank you for any help here, I really appreciate it! Any thoughts, comments, avenues are helpful as this is a unique situation :)
Interesting! Some thoughts off the top of my head...
I would think the Sponsor has the responsibility to follow the study until termination and site-close out. From a Sponsor perspective, I would think they would want the study to be completely closed out on their end and any further investigations to not occur under their protocol or responsibility. The Sponsor should notify FDA of the termination for the trial and reasons why, assessing patient safety aspects.
What would the intention be for the study to continue as an investigator led study if the Sponsor does not want the study?
I would think that the Investigators would need to submit their own protocol to the FDA under an investigator-IND from their institution which can include design aspects of compassionate use or enrolling new patients from the previously terminated Sponsor initiated trial....
Thanks for letting me comment. I'm interested to hear of the final outcome!
You don't need to withdraw your IND!!! Just transfer the IND holder from you (your company) to the Investigator!
See the detailed process below:
For the transfer to occur the new and former owners are required to submit the following information to the FDA:1. A letter from the former owner stating that all rights to the application have been transferredto the new owner (include effective date, IND #, new owner's name, address and contactnumbers) and that the new owner will receive or has received the complete IND files.2. A letter from the new owner with the following: - The new owner's commitment to agreements, promises, and conditions made by theformer owner and contained in the application;- The date that the change in ownership is effective; - A statement that the new owner has a complete copy of the approved IND application.If necessary, the FDA will provide a copy of the application to the new owner under thefee schedule in § 20.45 of FDA's public information regulations. - A statement that the new owner agrees a) to the promises and conditions made by the former owner, as well as to thoseagreements, promises and conditions contained in the IND applicationb) maintain a complete copy of the approved application, including supplementsand records that are required to be kept under 21 CFR 314.81c) to amend the IND within 60 days to cover any and all changes in the IND thatresult from the change in ownershipd) to provide subsequent changes by amendments in accordance with the INDregulationsAlso include the TORO and the following forms:Form 1571Updated Form 1572
CVs for the new investigatorsLetter of support from the study drug manufacturerIRB approval letter and approved ICFUpdated protocol with references to previous owner deleted and replaced with new owner.
Very interesting question and there are probably more details needed. However, in theory, you could just transfer the IND. However, I cannot see an investigator accepting full responsibility for the IND which would include a lot of other information as well e.g CMC, nonclinical, etc. Plus, I am not sure your company would want to share all that information that is contained in the IND. Usually in an investigator IND, there are referencing the commercial IND for the othered sections of the IND besides the clinical section. Of course, there are other situations where this may not be true.
Was the original question about transferring the IND or the study only?
The investigator could accept the IND but under TORO he/she could list the original applicant as responsible for the selective items that the investigator is unable to take!
The most straightforward approach, if I understand your situation/question correctly, is for the investigator to submit an investigator-initiated IND that cross-references your IND. With an ongoing program that seems to be leading to an NDA you do NOT want to withdraw or transfer your IND. You will need to keep your IND active.
The investigator would re-submit the protocol under their IND and accept any responsibilities of Sponsor, note that the Trial Master File has been transferred, and accept any commitments you made to the Agency related to the study.
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