Getting Ahead in Trial Design

Welcome to the June of Applied Clinical Trials (ACT) on trial design. A selection of features and articles in this edition reflect a theme that surfaces repeatedly across clinical operations today: The decisions made earliest in development—particularly in protocol structure, vendor strategy, and financial architecture—carry the most consequence.

That reality extends to patient-centered design as well. As Krishna Cheriath, VP and head of clinical research digital data and artificial intelligence (AI) at Thermo Fisher Scientific, put it in a recent Q&A with ACT, thinking about the patient experience after the protocol is locked “is no longer the way to go.”

In his view, the biggest opportunity lies in infusing AI-augmented intelligence into trial design itself, which can aid in anticipating patient burden, site burden, and enrollment potential before they become problems.

A pair of features in particular in this issue examine what it looks like when that kind of early rigor is applied across execution strategy and vendor oversight, respectively. Overall, they make a case for a more integrated, front-loaded approach to how trials are designed and operationalized.

For example, our cover story examines a problem most sponsors don’t recognize until it’s too late: execution instability that originates not in study conduct, but in strategy timing. Author Elizabeth Walsh, PMP, ACRP-CP, argues that by the time a contract research organization is engaged, the decisions most likely to determine whether a study succeeds have already been made and rarely tested against operational reality.

The piece makes the case for integrating execution oversight expertise far earlier in development planning, before assumptions harden into contracts and investor commitments.

Following is a feature on embedding environmental, social, and governance (ESG) considerations into clinical vendor oversight. Author Otis Johnson, PhD, MPA, contends that sustainability efforts lose traction when managed as a standalone reporting exercise. He offers a practical framework for folding ESG metrics into the governance structures, scorecards, and corrective action processes that trial teams already use to manage risk and performance.

As always, thank you for reading.

Mike Hennessy Jr is chairman and CEO of MJH Life Sciences®