Weak Trial Protocols Make Sites Feel Doomed to Fail

Kristen Bennett, Associate Director for Client Delivery, The Avoca Group

Kristen Bennett, Associate Director for Client Delivery, The Avoca Group

“Maybe this sounds a little emotional,” says Kristen Bennett, associate director for client delivery at The Avoca Group, Inc., a life sciences consulting firm, “but I think we have to take all of this to heart, to see how we can improve running clinical trials [by] keeping in mind why we do it [and] never forgetting we do this for patients.”

Bennett has steeped herself in various clinical trial vantage points. A former clinical research coordinator, she has also spent time as a project manager at a contract research organization (CRO). To improve trials and foster better working relationships across the spectrum, she wants to see greater focus on protocol quality and specifics with eligibility criteria, schedule of visits, and others.

“I feel like sometimes we’re writing protocols that are just not easy to execute,” Bennett says. If a site is burdened with “crazy eligibility criteria,” staff there will feel “set up for failure,” she adds. For example, sometimes a protocol might lift too directly from a different therapeutic area and “you’re just hoping that it fits in,” she says.

That site perspective was at the front and center of a recent survey conducted by the Association of Clinical Research Professionals (ACRP) and Avoca that asked industry players to weigh in on the key attributes that drive quality in clinical trials from the site perspective. In the survey, investigational sites were asked to rate sponsor and CRO attributes (including responsiveness to questions, knowledge of the study protocol, and frequency of clinical research associate turnover, among others) and study execution (including setting of realistic patient recruitment goals, design of case report forms, and ease of electronic data capture systems).

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“I was really happy that the sites [in the study] spoke up about specifics of quality and protocol design, especially regarding eligibility criteria,” Bennett says.

For Bennett, the stakes of getting clinical trials done right could not be higher. “We all have family and friends affected by all different kinds of diseases, and this is why we do clinical trials,” she says. She adds that practitioners need to remember that “everything we do to execute a clinical trial—communication, ensuring you have the right staff, protocol quality, support from the sponsor down to the site—all of that is done every day so that we can help patients get the medicines they need.”

Author: Michael Causey