Policy statement of the American Society of Gene Therapy on reporting of patient adverse events in gene therapy trials.

Abstract

The current ORDA web site shows that this office has taken on additional responsibilities. As the Office of Biotechnology Activities (OBA), there is now the mandate to administer three separate advisory committees that address disparate topics. To fulfill the challenges inherent in administering pertinent data, entering them into the system and keeping the system updated, the OBA will need to be given appropriate resources so that the objectives of reporting serious adverse events in gene therapy trials can be met. The NIH has a continuing obligation to both maintain and improve public access to human gene transfer information.In conclusion, the American Society of Gene Therapy expects its members to adhere to the tenets of all the regulatory schema that are in place, as well as those provisions in the Proposed Amendments of the NIH Guidelines that are adopted in the future. Adherence to oversight principles is important in maintaining public credibility about a newer form of biotechnology that still seeks hard evidence of success, but that has tremendous potential in shaping future therapies for a wide variety of diseases. In that context, the ASGT fully supports the NIH in its efforts to establish clear directives about serious adverse events reporting so that tragic incidences can be reduced to the lowest possible level and so that the field can move forward in the most efficient and responsible manner.Thank you for your attention.