Executive Briefing Series (formerly The Food & Drug Letter)

Recruiting patients for clinical trials has become more difficult with the growth of globalization, as drugmakers seek to market treatments for smaller, more specific populations with unmet medical needs and as the number of trials has grown. But clinical trial sites, clinical research organizations, drugmakers, the FDA and other agencies and organizations are developing new strategies to boost patient recruitment. Those strategies include the tools of patient-centered outcomes research, data mining, genetic sequencing, working hand-in-hand with physicians and hospitals through unique partnerships and other tactics to help reach the right patients. In this issue of The Food & Drug Letter, the editors bring you news of new approaches to recruiting clinical trial subjects, including suggestions from FDA officials Margaret Hamburg and Janet Woodcock.

A new University of Michigan study offers tips sites can use to clear the hurdles of incorporating genetic sequencing into cancer clinical trial recruitment.

Making more use of patient-centered research would help sponsors recruit trial participants and improve the understanding of how drugs function in different patient groups, FDA Commissioner Margaret Hamburg and other experts suggest.

For a better shot at recruiting hard-to-reach patients, don’t assume that potential trial participants understand what a clinical study entails.

When recruiting clinical trial patients, research sites need to strike a delicate balance between overly broad advertisements that don’t target a trial’s primary population and ads that are so narrow that potential subjects may wrongly believe they aren’t qualified to be in the trial, according to a recruitment expert.

Drug sponsors should look to their peers as potential partners, not as competitors, if they want to create a more effective and efficient path to cancer drug discovery, CDER Director Janet Woodcock advises.

Sites dealing with physician concerns about patient poaching may want to take a page from site director Steve Kenney.

A new FDA draft guidance offers specific goals and methods to ensure that more women are represented in medical device clinical trials.