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Trial Changes

Francis Collins, the director of the US National Institutes of Health, and two colleagues outline changes the agency is making to improve the quality of clinical trials in an editorial appearing in the Journal of the American Medical Association this week.

Currently, Collins, Kathy Hudson, and Michael Lauer, all of NIH, say that while clinical trials have fueled advances in diagnosing, treating, and preventing disease, they can be improved. For instance, they say clinical trials are all too often "overly complex, have small sample sizes, rely on surrogate end points that lack clinical relevance, have unrealistic accrual rates, and have inadequate budgets."

To combat this, they write that NIH is implementing changes at key points of the lifespan of a clinical trial. First, NIH is to require Good Clinical Practice training for investigators and NIH staff who conduct or oversee trials. It is also going to require that clinical trials be registered at within 21 days of enrolling the first patient. At the same time, the agency plans to improve the website so that it is more user-friendly and can help both doctors and patients find relevant trials, potentially boosting trial enrollment.

According to Collins and his co-authors, there will also be penalties for investigators who don't abide by the new policies. For example, they say that investigators and sponsors who don't heed the policies could be subject to fines from the Food and Drug Administration and NIH could withhold funding to the investigators' institution.

"Although the process of enhancing the clinical trial pipeline may be a work in progress, the goal of all of these varied activities remains constant: to maintain public trust and to encourage advances in the design, conduct, and oversight of clinical trials," Collins and his colleagues wrote.