CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Norman Goldfarb, chairman of Model Agreements & Guidelines International (MAGI), an organization that has spent a decade promoting the standardization of clinical trial agreements (CTAs) and contract templates that both sites and CROs or sponsors can use to speed study startup. Goldfarb is also editor of The Journal of Clinical Research Best Practices, and managing director of First Clinical Research. In April, the Association of Clinical Research Professionals gave Goldfarb their award for innovation for the MAGI CTA initiative.
Q: Why have contracts between sites and CROs or sponsors traditionally been a problem?
A: It can take months for a study sponsor or CRO to negotiate a CTA with a research site. In contrast, you can put two real estate lawyers in a room and they can negotiate a $30 million real estate deal in three hours. It should not take three months to negotiate a $30,000 CTA. And, while we are negotiating, the patients have to wait.
Every study sponsor’s and CRO’s lawyers have developed a CTA template they think will accomplish that objective. These templates all have small but important differences in both substance and wording, and even the smallest change might expose the company to an unanticipated risk down the road. If a study participant is injured, for example, liability might be determined by an inconspicuous phrase like “to the extent that.”
Similarly, research sites have—or should have—their own lawyers, with different ideas about what CTAs should say. It’s not that anybody is against standardization; it’s just natural to define standardization as “do it my way.”
MAGI promulgates templates that are, to a large extent, acceptable to all parties in a clinical trial agreement—the sponsors, the sites and the CROs, which are usually the ones negotiating the agreements. The MAGI contract is meant to be neutral.
Q: Have there been other such initiatives? How have they performed?
A: The National Health Service and the Association of British Pharmaceutical Industry have negotiated a standard CTA in Britain. But in Britain, almost all healthcare is provided by the National Health Service, so as a result, it wasn’t as complicated to negotiate that as it has been for sites and pharmaceutical companies here to negotiate a similar standard template. The U.S. is a very diverse nation when it comes to healthcare providers.
In the U.S., there have been a few CTA standardization initiatives over the years, but they have mostly just dissipated. These efforts have been primarily driven by a small number of research sites, and included elements that sponsors ultimately found unacceptable. When the parties got to the end of the process, the sites said, “Here it is; let’s use it,” and the sponsors said, “No, sorry, it’s not going to work for us after all.” In contrast, the MAGI process has been very inclusive, with hundreds of contributors over the years.
Q: Are we getting any closer to acceptance and standardization in these contracts now? What does the future hold?
A: The MAGI CTA template and handbook are widely used by sponsors, CROs and sites to find common ground in CTA negotiations. But we still have a long way to go.
Over the past couple of years, MAGI has been joined by two other initiatives—the Clinical and Translational Science Awards program has developed the Accelerated Clinical Trial Agreement (ACTA) CTA template with backing from academia, and the Society for Clinical Research Sites, along with TransCelerate and the Association of Clinical Research Organizations (ACRO), has developed CLEAR, a set of standard CTA clauses. Obviously, the clinical research enterprise does not need three different standard CTA templates, so the best solution is to merge them into a single template with optional text where needed. We’ll have a working session at the next MAGI conference to start that process. If we can all agree on common language, there is a good chance of wide industry adoption. As we like to say, “We can agree to save lives.”
In 10 years, I think chances are very good that we will have a standard template that, in some cases, the parties will decide works as-is, and in some cases will choose various plug and play options within it. We cannot expect one solution to fit everyone’s needs, but we can severely limit the scope of the negotiations by settling on a few options that cover most of the needs. People can choose between those or combine them, and there can still be some custom language.
We live in a heterogeneous society. MAGI’s objective is not to come up with one standard template that can just be signed as-is, but rather to come up with a template that industry can converge on over time, causing negotiations to drop from months to days or even hours.
This article was reprinted from Volume 21, Issue 19, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »