ASGCT Press Release

Harmonized reporting of serious adverse events in gene therapy trials urged by the American Society of Gene Therapy

MILWAUKEE-The American Society of Gene Therapy (ASGT) reiterates its position that gene therapy has tremendous potential to positively shape future therapies for a variety of conditions including inherited disorders, cancer, heart disease, neurological disorders, AIDS and other infectious diseases. As all clinical trials in search of new therapeutics carry certain risks and gene therapy is a new area of biomedicine, timely reporting of serious adverse events that occur during clinical trials is imperative.

These outcomes are only useful if reported and disseminated to both the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). It is the view of the ASGT that the two federal agencies jointly establish a completely harmonized set of requirements so that investigators can interpret a single set of definitions and follow a single standard. The harmonized requirements must satisfy the legal and regulatory aspects of the FDA, and provide the public with useful and relevant information regarding gene therapy trials. A unified definition of reporting guidelines on serious adverse events will effectively clarify outcomes. This is indeed an important role in the present and future of gene therapy.

The ASGT fully supports the NIH in its efforts to establish clear directives about and procedures to ensure compliance of reporting serious adverse events in gene therapy. To ensure that the public has accurate information about the safety or risk of gene therapy, it is important to differentiate serious adverse events that occur as a result of gene therapy from those that occur as a result of the disease itself. Patients engaged in various gene therapy trials are often very ill with terminal diseases and many succumb to their underlying diseases over time. Thus, this distinction is critical to patients, the public, as well as to researchers.

The ASGT continues to dedicate itself to the understanding of gene therapy and to fostering the exchange and dissemination of information and ideas related to it, as well as to the FDA's commitment to ensuring compliance amongst all researchers. All ASGT members are expected to vigorously abide by all federal regulations. To this end, the ASGT will incorporate an educational session on compliance in clinical trials at the society's Third Annual Meeting, May 31 - June 4, 2000 in Denver, CO, which will be co-organized by the FDA and NIH.

The American Society of Gene & Cell Therapy (ASGCT) is a professional non-profit medical and scientific organization dedicated to the understanding, development and application of genetic and cellular therapies and the promotion of professional and public education in the field. For more information on ASGCT, visit its website, www.asgct.org.

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