Are clinical trial participants a true representative of our population?

Our editor, Laura Hughes, discusses the clinical trial processes for drugs and devices.

Getting a medical device to market is a time-consuming and challenging task. Following classification of the device, a Notified Body (NB) of any European state examines the application to ensure compliance with European regulations and awards the CE mark for the device to be marketed within Europe where possible.

However, gender bias often exists within clinical trials according to a scientific article published within the Pharmacy Practice journal. In fact, the National Women’s Health Network (NWHN), a consumer activists group, has long advocated for the greater participation of women and other key groups in clinical trials for all drugs and devices – particularly those which are to be marketed and used predominantly by women.

Previously women were excluded from clinical trials for reasons such as hormone fluctuations due to menstruation, as well as fears of including women who may become pregnant during clinical trials. However, we now know that the cells of men and women are very different and therefore reactions may differ for a drug or device within each gender.

In fact, it was only as recently as 1993 that the National Institute of Health (NIH) Revitalization Act was implemented. This regulation meant that women and minorities must be included in any clinical research funded by the NIH. However, trials run by drug companies did not have to follow this regulation. Shortly after this, in 1998, the Food and Drug Administration (FDA) brought out a regulation stating that new drug applications must present safety and efficacy data by sex, and the demographics of participants in clinical trials must be included in innovative new annual drug reports.

With claims that in a study testing for female Viagra, 23 out of 25 participants were men, it is probably no surprise that many drugs have been withdrawn from the market after finding out that they are more harmful to women than men. We need to look as far back as animal research, where male animals are often used instead of female animals for testing drugs and devices.

In terms of medical devices, the 510(k) clearance programme in the USA allows devices to get to market quicker – something that may not always be seen as an advantage e.g. in the case of the transvaginal mesh implants. In 2018 in the UK, the NHS announced the Accelerated Access Collaborative – a scheme to speed up the approval of five drugs or devices each year. However, it is important to note that although this speeds up NHS approval, it does not impact the standard regulatory approval times of drugs and devices.

A recent report by digital health company, Antidote, included results of findings from a survey of 4,000 patients and caregivers about their attitudes to clinical research. A key finding was that there is a real difference in the motivation between people of different races, regardless of their condition when choosing to volunteer for clinical research. As described above with the female gender, there is a clear misrepresentation of different races within clinical research. A paper published in the Journal of the National Medical Association highlighted the importance of this, as research has shown that there are significant differences among racial and ethnic groups in the metabolism, clinical effectiveness and side effect profiles of drugs.

Although I believe we have come a long way, there is still a huge amount more to be done for clinical trial participants to be considered a true representative of our population. Raising awareness through talking out about the issue is the best way for those who have the opportunity to change this to take notice. After all, a more equal representation of clinical trial participants, will hopefully ensure a safer drug or device for everyone, and not just those who make up the majority of clinical trial subjects.