Sarah Ferranti Quoted in “Clinical Trial Agreements Evolving as Postpandemic Era Gains Traction”

CenterWatch

Sarah V. Ferranti, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, was quoted in CenterWatch, in “Clinical Trial Agreements Evolving as Postpandemic Era Gains Traction,” by Charlie Passut.

Following is an excerpt:

As the pace of nonCOVID-19 trials picks up, some contentious issues are arising in the negotiation of clinical trial agreements (CTAs), partly due to what sites were willing to agree to at the height of the pandemic when most CTAs focused on COVID vaccines or treatments. …

Attorney Sarah Ferranti of Epstein Becker & Green, who primarily advises sponsors and sites but has also represented CROs, said she frequently sees new and updated terms in CTAs, especially in the traditional contract terms on indemnification and subject injury.

“We are continuing to think through in the context of COVID-19 and on whether a clinical trial sponsor is possibly picking up the costs associated with a COVID-19 infection,” she said. “That’s where the difference in language might matter. If a sponsor is covering costs arising from participation in a clinical trial, that could pick up if a patient went to the site and got COVID-19. But if the sponsor is covering costs that were directly caused by administration of a study drug, that excludes a potential COVID-19 infection. There are also some wrinkles when the study drug itself may be something that makes the patient more susceptible to a serious infection. So these liability terms have shifted a bit.” …

Ferranti said CTAs will need to address issues surrounding data-sharing. “Both sides need to be really thoughtful about how data can be used by both the sponsor and the site. Sites want to potentially make more use of clinical trial data as the world recognizes the value of data going forward.”

She added that CTAs will also need to accommodate third parties involved in research that are independent of sites and sponsors — such as telehealth companies, pharmacies and labs. “It used to be that every piece of a trial would happen under one roof. Now a trial can occur in a patient’s home or the local lab or a variety of different locations. How we assign responsibility for oversight of various activities and how the data-flows will work has required some shifts in thinking about how we’re going to contract around a regulatory framework that isn’t perfect any more for these different ways of implementing trials.” …

The decentralization of clinical trials has also changed the nature of CTAs, said Ferranti. “During the pandemic, we added the language to CTAs that was needed to keep people out of provider sites and to pay more attention to diversity,” said Ferranti. “Today, we have sites that want to be able to add one or two elements to the CTA, like telehealth appointments and electronic consent. We get a lot of questions about how the FDA regulations, which were designed in the context of a brick-and-mortar trial, apply in a decentralized or remote trial because the investigator may not be as able to personally conduct the study or control the study drug. Those things are all in the regulations, but they have to be implemented in a different way. Those complexities need to be worked out.”