At a 23 April meeting on modernizing clinical trials hosted by the US Food and Drug Administration (FDA), a major player in the drug-discovery world argued that the agency should do more than encourage innovation. What is needed is a person to oversee those innovation efforts, says Doug Peddicord, executive director of the Association of Clinical Research Organizations based in Washington DC.
Since 7 March, the FDA has been shopping for fresh ideas to reinvigorate clinical trials. Peddicord said he’s heard this request before. “We’ve been talking about these ideas for a number of years, and I would argue that we need to go big if we want to modernize clinical trials.”
Indeed, the FDA has heard testimonials from investigators, industry leaders, clinical-trial regulators and patients since 2004, when they established the first in a string of initiatives to revamp these crucial studies in drug development. “There’s been some progress in developing basic building blocks, but [drug discovery] remains costly, slow and unproductive,” said Peddicord. His point is undeniable. About 13 years pass between the time when a drug is discovered to when it’s FDA approved, and the process costs an estimated US$1 billion.
The drug industry and the FDA remain in a stalemate that stifles innovation, Peddigard said. The FDA encourages companies to try new practices, but they don’t offer assurances that developers won’t be later penalized for deviating from the norm.
Specifically, Peddigard said that his organization is pushing for a ‘chief innovation officer’ at the FDA, who would work with stakeholders that want to test new clinical-trial mechanisms. For instance, the officer might approve a study, within a clinical trial, to compare efficacy of a 3-minute video that tells a patient about a study to a 15-page consent form. By getting approval from the FDA officer to run the study, the industry could rest assured that the agency wouldn’t later fault them for the video approach to consent. Last summer, the head of the Biotechnology Industry Organization, a biotech trade group based in Washington DC, pushed for an innovation chief as well.
“The concept seems right, but I’d be surprised if one person could handle this,” says Robert Califf, a cardiologist at Duke University in Durham, North Carolina; the co-chair of the Clinical Trials Transformation Initiative, a partnership launched in 2007 that identifies practices to increase the quality and efficiency of clinical trials; and a co-author on a US Institute of Medicine report on innovation in clinical trials, published 13 April. “There does need to be a safe haven so that you can try new things and not be penalized,” he says.
At the hearing, held at the FDA’s headquarters in Silver Spring, Maryland, it wasn’t clear how members of the FDA panel took to the idea of a chief innovation officer. In an e-mail to Nature, Kathleen Uhl, meeting chair and director of the office of medical policy, writes, “The FDA will consider and take under advisement the suggestions received at today’s hearing.” The second day of the hearing has been cancelled, but the agency will read any comments received before 31 May.
Recent comments on this blog
Experiments reveal that crabs and lobsters feel pain
US research ethics agency upholds decision on informed consent
Chemistry credit disputes under the spotlight
Chemistry credit disputes under the spotlight
Contamination created controversial ‘acid-induced’ stem cells