Article | December 4, 2018

Study Change Requests – A Test Of Agility, Efficiency And Experience

Source: Cenduit LLC

By Christopher Gent, Associate Director, Operational & Process Excellence, Cenduit

Gears In Hands

Clinical studies are like fingerprints: no two are identical. The notion of a purely “configured based system” is a myth.

Study protocols are becoming more complex and trials are dying faster, with patient recruitment remaining the number one problem. We’re seeing more and more studies with protocols that change as we are configuring the system in our IRT environment, or that change shortly after go-live. In fact, about 50% of studies will need a protocol amendment, often on the fly.

When a sponsor requires an amendment it triggers the change control process, or what we call a Study Change Request, or SCR. These can be simple, like clarifying usage instructions; or they can be significant, like requiring changes to the study design.

This trend is being driven by costs. Sponsors want to save money by doing fewer, more complex trials. The thinking is that if a sponsor runs one large, complex trial with a flexible protocol they can get results quicker, and make changes as they deploy.

Of course, because of reporting requirements sponsors want changes completed as soon as possible. But speed doesn’t necessarily translate into quality, and mishandled SCRs can delay a study for months, or even kill it. Clients have to trust in the experience and skillset of the IRT provider’s team and their ability to fulfill SCRs while scrupulously maintaining data integrity and patient convenience and safety.