The Administrative Management Division for Clinical Drug Trials (ACDT) at Fukuoka University Hospital: Advance hearings by the ACDT staff: Second report

The Administrative Management Division for Clinical Drug Trials (ACDT) at Fukuoka University Hospital was established in July, 2001, and has recently expanded to include seven new staff members: one physician, 3 clinical research coordinators (CRC), one pharmacist, and two office workers who joined in April 2002. A policy of an "advance hearing", where the details of clinical drug trials are reviewed before consideration by the Institutional Review Board (IRB) of Fukuoka University Hospital, has also been introduced. An advance hearing is performed using an advance hearing form consisting of 5 parts: a clinical trial outline, protocol, consent form, case report form, and attachments. Twenty-eight clinical drug trials, including 3 clinical trials after marketing, were scheduled from July 2001 to June 2002, and 555 questions raised by the ACDT staff were summarized. Two hundred forty-six (44.3%) of the 555 items were revised from the initial forms submitted by pharmaceutical companies. The questions mainly focused on pharmacokinetics/pharmacodynamics in the clinical drug trial outline, methods for trials in the protocol section, the ease of understanding the document for informed consent, establishing patient identity numbers in the case report forms, and the poster bulletins forms in the attachments. When the number of questions at such advance hearings was assessed according to each trial phase and according to whether the pharmaceutical company was domestic or foreign, no change was observed among the phases but foreign-affiliated companies required significantly fewer revisions in the consent form than domestic companies (9.06:′4.68 vs. 16.00′7.46, p<0.05). A careful review and understanding of clinical drug trial documents by the ACDT staff has proven to be beneficial for the deliberations by the IRB, and these advance hearings are thus considered to be an important tool for improving the quality of clinical trials.