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Shortage of Clinical Trial Participants

Thursday, December 11th, 2008

By Maureen Martino www.raps.org

As the public’s knowledge of clinical trials grows, so does biopharma’s difficulty recruiting patients for studies. The Philadelphia Business Journal reports that drug developers have a backlog of experimental drugs that need to be tested in humans, but there’s a shortage of participants willing to enroll in clinical trials. High-profile mishaps and other safety issues make the public wary of becoming involved in clinical trials. “Knowledge about clinical trials has increased dramatically. With that awareness, you’d think it would be easier to recruit. But what is happening is we have more clinical trials than ever before and the FDA is requiring more patients be in studies so more safety data can be gathered,” notes Liz Moench, president and CEO of MediciGlobal.

Biopharmas and CROs are using a number of methods to reach out to potential clinical trial participants. Some are sticking with traditional media such as radio and newspaper ads, or moving trials overseas. Others are turning to the internet, scanning disease-specific social networking sites for potential volunteers. Boston’s Center for Information & Study on Clinical Research Participation (CISCRP) is approaching the issue from another angle. Since 2004 the group has been trying to change public perception about clinical trials, promoting participants as heroes (similar to the strategy used for organ donation).

“The need for outreach and education is clear: 74 percent of the public say that they have no ‘real’ knowledge of the clinical research process, and 98 percent don’t know where and how to identify and evaluate appropriate clinical studies,” Diane Simmons, CISCRP’s president and CEO, tells the Philadelphia Business Journal. “Even though the public has been exposed to a tremendous number of recruitment ads, response rates are as low today as they were 20 years ago.”

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FDA Education Program Awarded

Thursday, December 11th, 2008

“FDA Patient Safety News,” the FDA’s monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors.

The ISMP Cheers Awards honors organizations that have set a superior standard of excellence for others to follow in the prevention of medication errors and adverse drug events.

“FDA Patient Safety News” is broadcast monthly over several medical satellite television networks to more than 4,500 U.S. hospitals and long-term care facilities. It conveys safety information about drugs, devices and vaccines directly from the FDA to physicians, pharmacists, nurses, risk managers and educators across the country; reports on recalls and safety alerts and medical errors; and provides tips on how to protect patients.

The program’s video format makes possible the demonstration of patient protection techniques; showing of recalled and counterfeit products; illustrating how medical errors occur; and demonstrating how to reduce risks when using medical products.

In addition to the monthly satellite broadcasts, a link to the show is distributed by e-mail every month to approximately 170,000 subscribers. The program also has its own Web page, http://www.fda.gov/psn, where viewers can download the videos or watch them online, read or print the story scripts, or subscribe to receive the program via video podcasting or RSS feed—all free of charge.

“FDA Patient Safety News” is intended primarily for a professional audience. However, on the assumption that health care professionals will discuss these topics with their patients, some of the videos include information for patients or consumers.

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