Attendees at the recent MAGI Clinical Research Cloud Conference heard advice from a variety of industry experts on running clinical trials now and into the “new normal.” The following is a selection of speakers’ thoughts on subjects from patient recruitment to negotiating clinical trial agreements (CTA).
Subject recruitment is one of many areas of clinical research being affected by the current COVID-19 pandemic. Some sponsors and sites halted recruitment when the pandemic broke out because of staffing difficulties and trouble securing personal protective equipment.
To mitigate those problems, sites should consider whether study procedures or consenting can be done remotely; continuously assessing whether they need additional sites, including rescue sites; amending the protocol; and rescreening subjects who were reluctant to come into sites earlier but may be more willing now that some pandemic-related restrictions are easing. Rosanne Petros, associate director, global clinical trials management at Merck
New recruiting methods developed before the pandemic hit will help trials carry on. Even before the COVID-19 outbreak, the industry was in a “golden age of recruitment” due to the technology and resources available, and those developments have only accelerated due to the pandemic. “The tools that we have are more vital now than they ever were” in regard to using a centralized recruitment model, using electronic health records and matching participants with studies, and crafting the messaging that really highlights that the public are the key factor in participation. Christopher Gantz, senior director of the Sidney Kimmel Cancer Center
Processes for reaching patients remotely also are key in the pandemic environment. “Options for remote consent are likely to become more common” as well as things like “study-specific disaster risk assessment as part of our readiness plan.” The goal is to “have in place processes that support the kind of flexibility in our practices that enable us to be resilient and responsive to unexpected disaster on the worst side, but to flexibility on the most thoughtful side.” Shanley Curran, attorney, Boston Scientific
Budgeting and contracting also are feeling the impact of COVID-19. The clinical research industry is having to consider some new scenarios in drawing up legal paperwork. Consider this hypothetical case: A subject contracts COVID-19 and dies from it while recovering in the hospital from a stent that has been implanted according to the study protocol. The question arises as to who will bear the costs of the deceased patient’s treatment. Federal government or private insurance pays for some COVID-19 treatment costs but does not pay for all diagnosis or hospitalization costs, requiring a review of the clinical trial agreement. From the site’s perspective, typical contractual language would obligate the sponsor to pay for whatever costs are not covered in this scenario as long as the site was following the protocol. Conor Flynn, contracts manager at the State University of New York at Buffalo
Sponsors might take a different view in that hypothetical case, concluding the patient may have caught COVID-19 due to failures in sanitation by site personnel. Moreover, a sponsor should have a clause in the CTA saying it would only agree to cover the costs for injuries caused by the stent and not those caused by following the protocol, which constitutes “standard of care” for the patient’s prior condition. Katherine Leibowitz, attorney and outside counsel for industry sponsors of multicenter studies
When negotiating through differences like those, don’t treat the other party as the enemy. Remember that everyone wants a deal so that the trial can commence. Freddy Iwan, head of legal management and legal counsel at WCG Clintrax Global
When reviewing the individual sections of a CTA, “look at the overarching concepts that you’re trying to obtain within the agreement” and be prepared to accept alternative wording that achieves the same goal. Chad League, senior contracts and grants administrator at MedStar Health Research Institute
Sites should keep their standards high despite the current crisis. “Continue to use the regulations as the floor, not the ceiling.” Everyone involved must exercise their best judgment. Lasting regulatory change may be coming, but for now “temporary allowances to get us through this pandemic” are the order of the day. Quincy Byrdsong, associate vice president for research administration at WellStar Research Institute