The Academy of Pharmaceutical Physicians and Investigators (APPI) has joined the Clinical Trials Transformation Initiative (CTTI), the broad-based coalition established by the Food and Drug Administration (FDA) and Duke University Medical Center last November in an effort to improve the quality and efficiency of clinical trials in the US.
Based in Alexandria, Virginia, APPI is a non-profit group of nearly 1,200 physicians involved in clinical research. The former American Academy of Pharmaceutical Physicians is an affiliate of the Association of Clinical Research Professionals (ACRP), also based in Alexandria and with nearly 21,000 members worldwide.
“As the leaders of the clinical research teams that test the safety and efficacy of potential new drugs and devices, physician investigators are in the prime position to spearhead efforts to make the trials process work better,” noted Dr Charles Alexander, president-elect of APPI. “Our goal in joining CTTI is to support its collaborative efforts on behalf of everyone from the human subject volunteers in clinical trials to the researchers to the patients who will benefit in the future from FDA-approved products.”
As a contributing member of CTTI, APPI will choose one representative from its membership to serve on the Initiative’s Steering Committee. This representative may then nominate other individuals from APPI to work on any future project teams or special interest groups.
Among the areas CTTI has talked about exploring are establishing national standards to streamline current approaches to initiating and conducting clinical trials; alternative models for Institutional Review Boards to minimise duplication of effort in multisite trials; identifying strategies to enhance the informed-consent process; setting up accreditation programmes for clinical investigators and research sites; and expanding the use of technology to improve data management.
A 12-member Executive Board was appointed to oversee the Clinical Trials Transformation Initiative in May.
