Clinical Sites Must Adapt to Technological Change

New clinical trial technologies pose increasingly difficult problems that research sites must be prepared to resolve, experts say.

Among the challenges sites face are using new types of clinical trial designs, new nonclinical support paradigms, innovative and advanced therapies, biomarker techniques and methods of estimating starting and stopping doses, Beatriz Silva Lima, a professor of pharmacology and member of the European Medicines Agency’s Committee on Human Medicinal Products, said at the Drug Information Association’s annual meeting.

When it comes to implementing functional biomarker assays in clinical trials, sites should “be open to taking these on — willingness to participate is key for us,” Amgen’s Director of Medical Sciences Andrew Welcher said.

Functional assays are more complex than traditional biomarkers, but they provide more useful information. “Our first goal is to demonstrate … that the target is modulated by the drug in the tissue. Then, [we must ask if we can] use the data to guide dose-ranging studies,” Welcher said.

This process is part of the FDA’s Critical Path program and similar to initiatives in Europe, he added. While his group at Amgen has focused on using biomarker assays in exploratory or early-phase trials, it also is using them in some registrational or late-phase trials as well as in certain postmarketing studies.