National Gene Vector Laboratory (NGVL) Toxicology Core Center
Unexpected or serious adverse events (SAEs) represent a potential danger in any clinical trial. To minimize the likelihood or seriousness of such events occurring during clinical research, toxicology studies are frequently required by the FDA before a trial is initiated. However, many grants do not provide support for such studies. In addition, toxicology data that are generated are usually considered to be proprietary and held within a Drug Master File, unavailable to other investigators. Consequently, toxicology studies are often repeated at great cost to both the research community and funding entities.
Toxicology Centers are funded through this cooperative agreement in order to generate and share toxicology data relevant to particular gene vectors. The Toxicology Center will be responsible for conducting animal and in vitro toxicology studies that the FDA determines are needed before a particular clinical gene transfer trial can begin. The Toxicology Center obtains, collates, analyses and stores the data generated. The data will be transmitted in the appropriate format both to the investigator for subsequent transmission to the FDA and to the NGVL Coordinating Center for inclusion in the Toxicology Master File.
Applicants designated as Toxicology Centers within the NGVL network are able to perform toxicology studies on vectors for NGVL-approved protocols. The resultant information from these studies will be maintained within NGVL databases and made accessible to the scientific community. The applicants provide expertise, prior experience and facilities to conduct animal studies in support of human clinical trials. Animal facilities are in compliance with local, State and Federal requirements. Informatics and statistical infrastructure, procedures for transfer of data into the NGVL Toxicology Master File, quality control and quality assurance procedures are provided by the applicants.
