Unnecessary and dangerous: Examining the need to carry out close-out medical tests after early termination of a clinical trial
Sow Wei Wong1, Centre For Biomedical Ethics 1Centre For Biomedical Ethics Singapore
Abstract
Clinical trials are bookended by medical tests at the beginning and end of the study. The first tells the researcher the state of the subject’s health when joining the study and the last one (“Close-out tests”), along with other tests conducted during the study hopefully shows whether the intervention studied had the desired effect. These tests such as x-rays, blood draws and endoscopies can be invasive, uncomfortable and risky. When the interim results suggest that the intervention is effective or otherwise, Close-out Tests provide the necessary data to prove this where the study is ended early. Where a study is terminated for convenience for reasons unrelated to safety or efficacy, the purpose and practice of carrying out Close-out Tests should be called into question. Even in such circumstances, Close-out Tests may be carried out because it would be a deviation from the protocol otherwise, investigators conducting sponsored research are remunerated according to the procedures they perform and such tests may also be perceived as beneficial by the study subjects despite being of little or no medical use. This paper will look at whether Close-out Tests should be carried out when studies are terminated for convenience. It will also look at how continuing to carry out Close-out Tests in such circumstances may vitiate the consent previously given because the assumption that the study will contribute to knowledge is no longer valid and that also changes the risk-benefit assessment of the study. This paper will then make recommendations to mitigate these concerns.
Biography
Sow Wei Wong is legal counsel at AbbVie Inc supporting its R&D activities in Asia and selected US therapeutic areas and Privacy. He is also currently pursuing a MSc by dissertation at the Centre for Biomedical Ethics. Sow Wei obtained an LL.M from the University of Malaya, qualified as a Barrister of Lincoln’s Inn and is called to the Bar in Singapore and Malaysia.