March 2020
Conversations around clinical trial agreements (CTAs) among sites are common in SCRS’ online community forum. Site executives frequently discuss approaches to negotiations involving payment terms and schedule, publication and intellectual property terms, how to navigate noncompliance, contract amendments, and more. Recently, a site executive posed a question to the forum regarding enrollment terms, and shared that the following statement was included in their CTA:
Failing to meet this enrollment requirement by Site shall constitute a material breach of this Agreement.
They followed this by saying that while the enrollment target is reasonable and achievable, the site was hesitant to agree to include the above ‘breach in Agreement’ clause because of the related repercussions if the enrollment target is not met. Insight to understand how to navigate negotiation of the clause was requested, and met with the following:
I wouldn’t do it! That’s a serious clause.
I agree – I would not accept it.
That clause should never be in a CTA – there are too many variables when screening and enrolling patients.
Better run! We avoid taking such studies. The sponsor is not being fair here.
Imagine if we started including clauses in CTAs that said something like, “Failure to provide adequate study supplies to meet enrollment target shall constitute a breach of contract.” What would happen then?
For the sake of your site and all of your colleagues, please do not accept this!
While the above responses may seem extreme, they clearly show how seriously SCRS member sites take these contract negotiations. If a site feels the sponsor is being unfair, that the CTA terms will not enable study success, or will potentially inhibit the site beyond the actual study, they are likely to pump the brakes. This does not happen solely for the success of the site in question; now that sites have a unified voice through their SCRS membership, the brakes are being pumped to ensure that one site does not lay groundwork that makes it more difficult for another site to advocate for their needs in the future.
Many factors regarding study enrollment are beyond the control of the site including changing timelines, protocol amendments and more. What if the trial is terminated during the recruitment period? Would it be constituted a breach in contract if central lab reports are delayed, thus causing the site to not meet their screening period? Or if a malfunction of the Electronic Clinical Outcome Assessment (eCOA) results in exclusions? From the site perspective, a clause like this is not just unfair to include, it also is not sensible.
SCRS knows that many of our sponsor Global Impact Partners already take site needs into consideration when drafting and negotiating CTAs, and we applaud the effort and work it has taken to make internal changes such as these. For organizations that have not yet adopted a more site-centric approach to CTA negotiations, we encourage you to do so. The shift will increase your organization’s ability to attract and retain quality sites for your clinical trials and create ongoing and lasting relationships.