In the wake of heightened concern aroused by the death of a patient in a gene therapy trial last September, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have launched two new initiatives to improve protection for patients participating in gene therapy studies. A number of such trials have been halted voluntarily by researchers or by the FDA.
Recent investigations have found that the clinical monitoring of some gene therapy trials had been "less than adequate," according to the two agencies. The first initiative, the Gene Therapy Clinical Trial Monitoring Plan, will intensify the level of oversight by requiring researchers to routinely submit their monitoring plans to the FDA for review. Trials will also be under FDA scrutiny to ensure that the plans are being followed and that monitoring practices have been adequate.
Stephenson J. Gene Therapy Trials Oversight. JAMA. 2000;283(15):1950. doi:10.1001/jama.283.15.1950