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The Potential of Gene Therapy Threatened by Early Tragedies

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Schooley says it takes thousands of hours to assemble the paperwork necessary to get a major study off the ground. Just last year, Schooley says the FDA shut down the entire research program at the University of Colorado for about 5 months over some alleged discrepancies in paperwork. Thousands of studies were halted, and investigators could not enroll new subjects until the matter was resolved.

"Patients with HIV infection in Colorado who wanted access to state-of-the-art clinical trials had no access for 6 to 8 months by the time all the studies were rereviewed," says Schooley. "It's bad for patients and bad for progress." A spokeswoman for the FDA declined to comment on the case.

One solution, says Schooley, is the creation of data safety monitoring boards, which are capable of gathering and reviewing data from different sites all over the country. The board would theoretically be able to spot problems that isolated review boards might miss.

 

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