InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.
Albert Einstein proffered the notion that insanity is doing the same thing over and over again and expecting a different result. Yet all too often when it comes to clinical trial agreements (CTAs), this is how we operate: Hoping to best protect their own interests, sponsors and CROs offer a template CTA with terms and conditions unacceptable to the overwhelming majority of institutions (ie, research hospitals and academic medical centers). To gain the strongest legal protections for themselves, institutions counter with terms and conditions unacceptable to sponsors. Most of the time, after weeks and sometimes many months, they agree on terms – pretty much the same terms with each institution and sponsor – and the CTA is duly executed. It takes too long, delaying research unnecessarily. Sponsors and their shareholders lose financial opportunity with each day of patent life lost. Institutions lose the opportunity to enroll a sufficient number of subjects. And subjects can lose the opportunity to participate in research.
For approximately the last 15 years, clinical trial opportunities have migrated from institutions to community sites, where CTAs are signed quickly, and studies start up efficiently. But for a variety of reasons, such as the acquisition of community practices by large healthcare systems, a growing number of clinical trials are conducted by institutions. Yet the process of study startup and CTA negotiation is largely unchanged, until recently.
Novartis has spearheaded a study startup innovation with its Signature series of oncology trials (https://www.signaturetrial.com/en). Although these trials have other interesting attributes, study activation is accelerated by three non-negotiable components: the budget, the independent IRB review, and the clinical trial agreement. Study startup at the institution must occur with 21 days. The end of insanity? Maybe.
At this time it is unclear whether this approach is workable on a larger scale, across multiple therapeutic areas, other sponsors, and most institutions. Because this is an industry (not institutional) initiative, some institutions may push back (although some now participate). Yet the concept makes such good sense… perhaps sponsors, institutions, and CROs will seize the day and move the ball down-court?
A group of academic medical centers may be doing just that. A two-year effort spearheaded by 25 academic medical centers – with input from 5 pharmaceutical companies – have developed the Accelerated Clinical Trial Agreement, or ACTA (https://www.ctsacentral.org/articles/ctsa-accelerated-clinical-trial-agreement). This agreement was developed to facilitate a streamlined and effective contracting process, allowing multiple sites to participate in company-sponsored trials earlier in the process. For sites that agree to use ACTA, further negotiation of the agreement should not be necessary. So far, 57 institutions have agreed to use ACTA. ACTA contains terms and conditions that as discussed earlier, are otherwise agreed to only after the insanity of re- re- re-negotiation – yet without the need to argue the same points again and again. With more widespread sponsor input, ACTA has the potential to reduce the time it takes for sponsors and institutions to reach agreement on the terms and conditions for the conduct of clinical trials. Together, institutions and sponsors that choose to accept a standard CTA can reduce clinical development time, and at last, end the madness.
InSites is a monthly column written by TIRS Editorial Board member Stuart Horowitz, PhD, MBA. Dr. Horowitz is President, Institutions & Institutional Services at WIRB-Copernicus Group.