RT Journal Article
SR Electronic
T1 Review of current controversial issues in clinical trials
JF General Psychiatry
JO Gen Psych
FD BMJ Publishing Group Ltd
SP e100540
DO 10.1136/gpsych-2021-100540
VO 34
IS 5
A1 Shein-Chung Chow
A1 Susan S Chow
A1 Annpey Pong
YR 2021
UL http://gpsych.bmj.com/content/34/5/e100540.abstract
AB In clinical development, adequate and well-controlled randomised clinical trials are usually conducted to evaluate the safety and efficacy of test treatment under investigation. The purpose is to ensure that there is an accurate and reliable assessment of test treatment under study. In practice, however, some controversial issues inevitably appear despite the compliance of good clinical practice. These debatable issues include, but are not limited to, (1) appropriateness of hypotheses for clinical investigation, (2) feasibility of power calculation for sample size requirement, (3) integrity of randomisation/blinding, (4) strategy for clinical endpoint selection, (5) demonstrating effectiveness or ineffectiveness, (6) impact of protocol amendments and (7) independence of independent data monitoring committee. In this article, these controversial issues are discussed. The impact of these issues in evaluating the safety and efficacy of the test treatment under investigation is also assessed. Recommendations regarding possible resolutions to these issues are provided whenever possible.All data relevant to the study are included in the article. All relevant data are available via the General Psychiatry journal from BMJ (https://doi.org/gpsych-2021-100540).