National Journal Devotes Issue to Project Led by TRI’s Laura James, M.D.

By David Robinson

Leading a team of five guest editors from CTSA institutions across the United States, James served as the first author of the journal issue’s editorial, “Scientia Pro Bono Humani Generis: Science for the Benefit of Humanity,” which introduces readers to the emphasis of the February issue.

The work was inspired by a 2019 paper in the Journal of the American Medical Association entitled, “Harms from Uninformative Trials.” The JAMA authors defined an uninformative trial as one lacking in meaning by the patient, clinician, researcher or policymaker.

In the JCTS editorial, James and her co-authors acknowledge the problems associated with uninformative clinical trials, writing, “Academic health organizations, funding agencies, and clinical trialists have been challenged to optimize clinical trial informativeness, and quality issues continue to plague the development and conduct of clinical trials.”

Multiple potential solutions are offered in the journal’s manuscripts, which highlight innovations for enhancing the informativeness and quality of clinical trials.

One example for improving clinical trial efficiency is the use of adaptive trials, James said. Adaptive trials use prespecified rules to modify the course of a trial and to optimize it based on the incoming results.

“Adaptive trial designs are a new approach to clinical trials that are moving us away from traditional double-blind placebo-controlled trials,” James said.

Infrastructure, training, participant recruitment and other factors are addressed in the report.

“We looked at multiple aspects of uninformative clinical trials in this issue, so we addressed common problems at the institutional as well as the study level,” James said. “We’re asking, what are the academic health organizations doing to ensure that their trials are of the highest quality, and are they really going to have an impact on human health?”

“As stewards of public funds that support the development of clinical trials, it is critical that we optimize clinical trial designs so that we create trials that move us forward in improving the health of individuals and communities,” she said.