FOR IMMEDIATE RELEASE Tuesday, March 7, 2000 Contact: FDA Press Office (301) 827-6250 NIH Press Office (301) 496-5787 New Initiatives to Protect Participants in Gene Therapy Trials FDA's clinical trials monitoring plan addresses emerging evidence that the monitoring by study sponsors of several recent gene therapy trials has been less than adequate. To buttress the rigor of the oversight, FDA will require that sponsors of gene therapy trials routinely submit their monitoring plans to the FDA. FDA will review these monitoring plans and seek modifications as warranted to improve the quality of monitoring. FDA will also perform surveillance and "for cause" inspections of clinical trials to assess whether the plans are being followed and whether monitoring has been adequate to identify and correct critical problems. The sponsors will also have to address such issues as the experience and training of the monitors and the adequacy of the monitoring in their plans. In addition, NIH and FDA will seek to enhance the conduct of gene therapy trials by convening a conference of investigators at which the appropriate monitoring practices will be discussed by the most experienced professionals in the field. Clinical trial monitoring is a powerful tool in enhancing the safety … Continue reading
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