Guinea Pig? Not Me! - Pharmaceutical Executive

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Guinea Pig? Not Me!


Pharmaceutical Executive

No wonder pharma companies are having a hard time recruiting patients for clinical trials. According to an online study of 2,031 adults conducted by Harris Interactive in February 2002, only a small minority of the public is confident that clinical trial patients get

  • high quality care (32 percent)
  • are not treated like guinea pigs (24 percent),
  • receive honest and accurate information (25 percent)
  • do not suffer more pain or side effects than they would from standard treatments (13 percent).

Nevertheless, most survey respondents believe it is "essential" (43 percent) or "very important" (40 percent) that all new pharma products be tested on humans before they are approved for general use.

So, what's a medical director to do? The study's authors suggest that a public education campaign may help turn those who are "somewhat confident" into "very confident." The main challenge is to reassure potential trial recruits that they will not suffer as a result of their participation and that they won't be treated as guinea pigs. But that is a giant hurdle, considering that FDA requires trial site investigators to have patients sign extensive informed consent documents.

One way to boost public confidence in participation is for pharma companies to sponsor trial-site education, such as the courses offered by National Institutes of Health's Human Participants Protection Education for Research Teams. That web-based course is designed to augment policies established by medical center institutional review boards and regulations enforced by federal, regional, and local agencies. A framed certificate from a trusted, independent institution such as NIH hanging on a recruiter's wall may make the difference in participants' attitudes between "somewhat" and "very" confident.

The industry also could encourage potential subjects to visit websites such as Veritas Medicine, which offers free, physician-bylined columns and online newsletters about human disorders from A to Z.

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