Regulatory Open Forum

Coming from a predominantly education-centered research institution, we don't see many drug studies. Occasionally we do, but we outsource them to commercial IRBs.

That said, I do have a general question about Phase 1 drug studies (or any phase):
Is it typical for a pharmaceutical company to pay university hospital PIs and/or large research institution PIs to recruit, consent, and administer their investigational drugs and collect biospecimens, but NOT actually have these PIs play any additional role in the study?

For example, after all the interventions are completed, all the data and documents would be immediately sent back to the pharmaceutical company for analysis and the research institution is then complete with the project and closes out their study with their IRB with no further involvement.

This is new to me but seems to be a bit of a conflict because:

1) There are no findings to present to the IRB in the closure/final report.
2) Why wouldn't the pharmaceutical company just use their own internal docs to run the trial?

3) If our PI is the one holding the IND, does this cause some concern?

Are there any other considerations I should be aware of?

Coming from a predominantly education-centered research institution, we don't see many drug studies. Occasionally we do, but we outsource them to commercial IRBs.

That said, I do have a general question about Phase 1 drug studies (or any phase):
Is it typical for a pharmaceutical company to pay university hospital PIs and/or large research institution PIs to recruit, consent, and administer their investigational drugs and collect biospecimens, but NOT actually have these PIs play any additional role in the study?

For example, after all the interventions are completed, all the data and documents would be immediately sent back to the pharmaceutical company for analysis and the research institution is then complete with the project and closes out their study with their IRB with no further involvement.

This is new to me but seems to be a bit of a conflict because:

1) There are no findings to present to the IRB in the closure/final report.
2) Why wouldn't the pharmaceutical company just use their own internal docs to run the trial?

3) If our PI is the one holding the IND, does this cause some concern?

Are there any other considerations I should be aware of?

Coming from a predominantly education-centered research institution, we don't see many drug studies. Occasionally we do, but we outsource them to commercial IRBs.

That said, I do have a general question about Phase 1 drug studies (or any phase):
Is it typical for a pharmaceutical company to pay university hospital PIs and/or large research institution PIs to recruit, consent, and administer their investigational drugs and collect biospecimens, but NOT actually have these PIs play any additional role in the study?

For example, after all the interventions are completed, all the data and documents would be immediately sent back to the pharmaceutical company for analysis and the research institution is then complete with the project and closes out their study with their IRB with no further involvement.

This is new to me but seems to be a bit of a conflict because:

1) There are no findings to present to the IRB in the closure/final report.
2) Why wouldn't the pharmaceutical company just use their own internal docs to run the trial?

3) If our PI is the one holding the IND, does this cause some concern?

Are there any other considerations I should be aware of?

What you describe (with one major difference) is pretty normal. The company hires the PI/site to conduct the study and pays accordingly. This is how most phase I units functions. Of course, there is nothing to prevent the PI to negotiate more involvement if they so wish. In academic environment publication rights might be important and something to be negotiated - although in the setting of a phase I it would not be surprising if the company will want to delay any publications. 

The IRB is not concerned about the results of the study. It is concerned about the risk/benefit ratio to participants. As long as they interactions with the participants is complete and all safety issues are addressed prior to closure of the study with the IRB it should not be a problem.

However, if the PI holds the IND it is a completely different ball game, as the PI is completely responsible to the entire life cycle of the protocol and is the one who need to report the results back to the FDA, as well as all other Sponsor obligations.

Coming from a predominantly education-centered research institution, we don't see many drug studies. Occasionally we do, but we outsource them to commercial IRBs.

That said, I do have a general question about Phase 1 drug studies (or any phase):
Is it typical for a pharmaceutical company to pay university hospital PIs and/or large research institution PIs to recruit, consent, and administer their investigational drugs and collect biospecimens, but NOT actually have these PIs play any additional role in the study?

For example, after all the interventions are completed, all the data and documents would be immediately sent back to the pharmaceutical company for analysis and the research institution is then complete with the project and closes out their study with their IRB with no further involvement.

This is new to me but seems to be a bit of a conflict because:

1) There are no findings to present to the IRB in the closure/final report.
2) Why wouldn't the pharmaceutical company just use their own internal docs to run the trial?

3) If our PI is the one holding the IND, does this cause some concern?

Are there any other considerations I should be aware of?

What you describe (with one major difference) is pretty normal. The company hires the PI/site to conduct the study and pays accordingly. This is how most phase I units functions. Of course, there is nothing to prevent the PI to negotiate more involvement if they so wish. In academic environment publication rights might be important and something to be negotiated - although in the setting of a phase I it would not be surprising if the company will want to delay any publications. 

The IRB is not concerned about the results of the study. It is concerned about the risk/benefit ratio to participants. As long as they interactions with the participants is complete and all safety issues are addressed prior to closure of the study with the IRB it should not be a problem.

However, if the PI holds the IND it is a completely different ball game, as the PI is completely responsible to the entire life cycle of the protocol and is the one who need to report the results back to the FDA, as well as all other Sponsor obligations.

Coming from a predominantly education-centered research institution, we don't see many drug studies. Occasionally we do, but we outsource them to commercial IRBs.

That said, I do have a general question about Phase 1 drug studies (or any phase):
Is it typical for a pharmaceutical company to pay university hospital PIs and/or large research institution PIs to recruit, consent, and administer their investigational drugs and collect biospecimens, but NOT actually have these PIs play any additional role in the study?

For example, after all the interventions are completed, all the data and documents would be immediately sent back to the pharmaceutical company for analysis and the research institution is then complete with the project and closes out their study with their IRB with no further involvement.

This is new to me but seems to be a bit of a conflict because:

1) There are no findings to present to the IRB in the closure/final report.
2) Why wouldn't the pharmaceutical company just use their own internal docs to run the trial?

3) If our PI is the one holding the IND, does this cause some concern?

Are there any other considerations I should be aware of?

Coming from a predominantly education-centered research institution, we don't see many drug studies. Occasionally we do, but we outsource them to commercial IRBs.

That said, I do have a general question about Phase 1 drug studies (or any phase):
Is it typical for a pharmaceutical company to pay university hospital PIs and/or large research institution PIs to recruit, consent, and administer their investigational drugs and collect biospecimens, but NOT actually have these PIs play any additional role in the study?

For example, after all the interventions are completed, all the data and documents would be immediately sent back to the pharmaceutical company for analysis and the research institution is then complete with the project and closes out their study with their IRB with no further involvement.

This is new to me but seems to be a bit of a conflict because:

1) There are no findings to present to the IRB in the closure/final report.
2) Why wouldn't the pharmaceutical company just use their own internal docs to run the trial?

3) If our PI is the one holding the IND, does this cause some concern?

Are there any other considerations I should be aware of?