I previously talked about clinical-trial agreements, that was my first blog, and the agreement I’m going to talk about today is the flipside of that.

The agreement I am going to talk about today is the Investigator Initiated Research or Trial agreement. These are sometimes referred to as IIRs or IITs. It’s important you know that these terms are interchangeable. The most important difference for you to know is that the Institution is the creator of the trial and dictate the terms of the trial with their protocol, not the company.

I’ve handled hundreds of these agreements and I am a pro. Reflecting on all of the agreements I’ve handled, I determined there are three primary things that you should consider or watch out for.

So without further ado…

 

1) Don’t Leave Openings To Lose Control Of The Trial

Be clear about the Institution’s role.  Given that the Institution is running the study, the Company wants to make sure that the Institution assumes all regulatory responsibilities as the Sponsor, rather than the Company.

 

2) Make It Clear The Institution Is The SPONSOR

Make it clear the institution is on the hook.  It’s THEIR study.

The Company has the right to be informed of the progress of the Study given that it’s their product, their money, but the Institution directs and monitors the activities including engaging with the regulatory authorities.

You don’t want to leave an opening for the company to take over. An example is where the company tried to claim control of the study results when it came time for publication. One company tried to block the Institution from publishing because they didn’t like the results. So here’s what happened: I had to have a “come to Jesus” meeting with the company and explain to them that you cannot stop the Institution from publishing just because you don’t like or agree with the results of the study. That’s the sort of mediation or protection that I provide when I negotiate these agreements on your behalf.

 

3) Publication is also a key component of these studies. 

Because the Institutions want to be able to publish the results, and you don’t want a company interfering with the institution that’s doing the publication.

You want to make sure the Institution has the right to publish the results of the Study and obtains the necessary background information provided by the Company in order to verify the research.

You also want to make sure the Company has the right to review the publication and can demand that the Institution remove any Company confidential information and/or give the Company time to secure any patent protection, but keep in mind that the Company cannot stop the Institution and/or Investigator from publishing the results even if they don’t like the results.

The most common instance of the Company taking advantage of this is if you have a clause in your agreement stating that certain information about the company’s confidential information is not allowed to be included in the publication.  These clauses are typically inserted at the Company’s request prior to trials taking place.

Again, this is Really getting into the nitty-gritty of IIRs and IITs, but it’s good to know.

4) Who Owns The Data!

The data that comes out of the trial is completely owned by the Institution (NOT the company).

The data, results and conclusions that come out of the Study belong to the Institution and Investigator, but usually… the Company wants the right to use the Data for any purpose.

Access to and use of the Data is key for the Company and the Institution and patent protection for any inventions or discoveries that might come out of the conduct of the Study.

Be careful you’re not losing those rights to the data.

 

Now You Know The Basics Of IIRs/IITs, And You Can Take Action To Protect Yourself

That’s all I want to share, because after that you’ve got to hire me! Schedule a call with me by clicking the link below.