Regulatory Open Forum

A colleague asked if it is possible for two companies to be listed as co-sponsors of a clinical trial.

I see no reference of co-sponsorship when a sponsor is defined in 21 CFR 312.3. Further, it seems as though the concept of co-sponsorship would unnecessarily complicate a matter which could be addressed by having one company transfer obligations to the other company. However, given that the transfer of obligations is to a CRO, according to the regulation, how would that be handled if neither company is a CRO? Perhaps there are additional FDA requirements of which I am not aware?

Also, does it matter whether one company is located outside of the US, or whether the clinical trial is conducted in both US and ex-US regions?

Thank you! I appreciate any insights.

A colleague asked if it is possible for two companies to be listed as co-sponsors of a clinical trial.

I see no reference of co-sponsorship when a sponsor is defined in 21 CFR 312.3. Further, it seems as though the concept of co-sponsorship would unnecessarily complicate a matter which could be addressed by having one company transfer obligations to the other company. However, given that the transfer of obligations is to a CRO, according to the regulation, how would that be handled if neither company is a CRO? Perhaps there are additional FDA requirements of which I am not aware?

Also, does it matter whether one company is located outside of the US, or whether the clinical trial is conducted in both US and ex-US regions?

Thank you! I appreciate any insights.

For the US FDA I don't think a concept of co-sponsorship exists in the sense of the 21 CFR 312 regulation of clinical trials. Someone has to file the IND and maintain it, i.e., own it. It would not be productive or efficient for both companies to file a single protocol to both INDs. If a company not holding the IND takes certain responsibility for regulatory requirements, that obligation can be easily and clearly transferred. Keep in mind that business arrangements can allow for co-development and both companies can bear responsibilities for conducting the clinical trial, but only one can hold an IND.

A colleague asked if it is possible for two companies to be listed as co-sponsors of a clinical trial.

I see no reference of co-sponsorship when a sponsor is defined in 21 CFR 312.3. Further, it seems as though the concept of co-sponsorship would unnecessarily complicate a matter which could be addressed by having one company transfer obligations to the other company. However, given that the transfer of obligations is to a CRO, according to the regulation, how would that be handled if neither company is a CRO? Perhaps there are additional FDA requirements of which I am not aware?

Also, does it matter whether one company is located outside of the US, or whether the clinical trial is conducted in both US and ex-US regions?

Thank you! I appreciate any insights.