“We don’t use technology well in clinical trials to collect information and use it to do quality checks on the data that’s collected,” U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, told an audience at the Reagan-Udall Foundation earlier this month (November 19).
Gottlieb advocated a better use of digital tools for capturing and auditing information to disrupt what he called legacy approaches. “They can provide better oversight [and] lower development costs and open up more trial sites—and more providers and patients—to opportunities to participate in trials,” he said.
He suggested that overly long, overly complex trials can deter patient enrollment, exhaust investigators, push trials out of the community setting, and delay completion of studies so long that their “findings are no longer relevant. Overly restrictive exclusion criteria can also screen out patients with a prior history of health complications.”
Gottlieb cited travel barriers as another significant complication in getting patients to participate in trials. An estimated 70% of Americans live more than two hours away from clinical study sites, he said.
Financial barriers (lost earnings from missing work, inability to pay for extended childcare, etc.) can also discourage patients from participating.
The impact is clear, according to Gottlieb. “As a result, only a fraction of U.S. patients—about 3 to 5% in the case of cancer patients—participate in clinical trials,” he said.
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Another downside: “This can raise concerns about how efficacy signals from traditional trials can be applied to ‘real-world’ patients who may be sicker, older, or less compliant than patients studied at academic trial sites,” he said.
“Clinical trials are major contributors to the cost of drug development,” Gottlieb noted. Costly trials can discourage the development of second- and third-to-market innovations, he added. “This leaves [the makers of] first-in-class products, particularly for rare indications, the ability to engage in monopoly-pricing power long after patents and other exclusivities have expired.”
Gottlieb told attendees to be on the lookout for an upcoming FDA study that found “nearly 50% of novel drugs approved from 1991 to 2000 had a competitor within two years. But it took five more years to achieve the same level of competition for drugs approved [in] the next decade, from 2001 to 2010.”
Novel trial designs incorporating digital tools and real-world evidence can help make trials more efficient, more reflective of diverse patient populations, and more accessible to patients where they live and work, Gottlieb said.
Gottlieb and the FDA have been active on the clinical trial regulatory front of late. He recently said the FDA was close to rolling out some specific policies aimed at reducing burdens on the conduct of clinical trials.
Author: Michael Causey