Regulatory
Improving diversity
A growing awareness that different demographics experience disease and medication differently has prompted industry calls for clinical trials to better represent the population a drug is intended for. With its November 2020 guidance on ‘Enhancing the Diversity of Clinical Trial Populations’, the US FDA is striving to move past the conversation about why diversity is important and drive the industry to take practical steps to change it. Monica Karpinski speaks with experts across the research sector, from regulators to patient recruitment specialists, about how industry professionals can look to this guidance, alongside work already being done in the research sector, to improve diversity in clinical trials.
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n March 2011, Lindsey Schweigert took one Ambien pill, a sedative, to help her sleep after a tiring business trip. She woke up in police custody – while under the influence of the drug, Schweigert had attempted to drive to a nearby restaurant but crashed into another car on the way. She had no recollection of the events whatsoever. Schweigert’s experience is shocking but not unique. Decades’ worth of post-marketing reports detail women’s experiences of cognitive impairment associated with Ambien and, in 2013, the US FDA realised that this was because the drug lingers in the blood for longer in women than it does for men, therefore, increasing their risk of adverse effects. The recommended dosage for women was then halved, but by that point, the drug had already been on the market for 20 years.
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It would take until 2020 for researchers to grasp the true scope of the problem – that women were experiencing side effects from medication twice as often as men, according to an article in Biology of Sex Differences – because the clinical trials for most drugs currently in use were conducted exclusively on men and prescribed at the same dose for people of both sexes. Recent years have seen increased institutional interest in correcting this bias and others like it, by ensuring that clinical trials accurately represent the population a drug is intended for. One such institution is the FDA, which released a guidance paper on the topic in November 2020; another is the journal JAMA, the revised publishing guidelines of which require that a broader range of demographic information is reported with trial data.
Clinical Trials Insight /
www.worldpharmaceuticals.net
Lightspring/
Shutterstock.com
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