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Why we need to talk about sex and clinical trials


A timely article given the recent publicity on the differing immune response between men and women in relation to Covid-19. In relation to clinical trials in the pharmaceutical industry, women have participated in clinical trials for many years. The introduction of a harmonised guidance for the pharmaceutical industry (ICH E3) in 1996, ensured that the number of women participating in a clinical trial, or a justification for their exclusion is recorded in the clinical study report Examination of efficacy or safety data for unusually large or small responses in subpopulations was advised, this often leading to formal or informal analyses of the separate male and female populations. The regulatory requirement to specifically analyse data separately for women came later. Analyses and comparisons of different subpopulations, be they based on age, sex, race/ethnicity are an essential part of the dossiers submitted to the regulatory authorities (e.g. EMA) when seeking a marketing authorisation. The cumulative data from the clinical studies undertaken during the clinical programme are more likely to detect efficacy or safety differences between men and women than a single trial. Even then, differences may not be detected until a drug treatment has been used in very large populations over a prolonged period of time. Fewer women participate in Phase I studies, but the investigations of PK/PD in patients are included in some Phase 2 and Phase 3 trials. The increased number of adverse events (side effects) observed in women indicate a higher exposure to the drug than in men, which in turn leads to the question of whether dose adjustments or differing dose regimens may be necessary. The decision of the FDA to reduce morning drowsiness by recommending a lower dose of zolpidem in women, and advising prescribers to consider using lower doses in men, has been questioned (1). At the time of the Blue Pill Pink Pill conference there was a lack of awareness that sex can influence the prevalence, diagnosis, drug efficacy and tolerance and surgical outcome. We have moved on since then with much more information available, but there is still work to be done and a need for this message to be disseminated to health professionals and the wider public. Ref: Grennblatt DJ, Harmatz JS, Roth T. Zolpidem and gender: are women really at risk? J Clin Psychopharmacol 2019; 39:189-199.

Posted date

3 JUN 2020

Posted time



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