Creating communications excellence

The true potential of medicines cannot be fully realised without expanding the patient base in clinical trials through diversity. Greater inclusivity in research is, in my opinion, one of the most important topics to address in clinical research and development, and one that we at 67health feel particularly passionate about.

Clinical trials should involve a cross-section of the patient population that the treatment is intended for – taking into consideration things like age, sex, gender, race, ethnicity and more. Without this, it’s difficult to apply the findings of the trial to the broad demographics of the patient pool. Some regulators are working towards clear guidance in terms of diversity in clinical research, like the US Food and Drug Administration, that may require a plan to be submitted ensuring diversity among trial participants when seeking approval for late-stage clinical trials. This is a positive step, particularly as some diseases disproportionately impact certain demographics.  For instance, African-American women are three times more likely to get lupus than white women, yet their relative absence in clinical trials is shocking and is the subject of a clinical ambassador programme we are developing with the international lupus community.

We can’t ignore the various and complex challenges around this topic, whether it’s medical mistrust, trial availability, access issues, eligibility criteria or enrolment practices. The good news is that much can be done to address these challenges and the biopharmaceutical industry is a key driver in this. Below are some of the ways the industry can play (and is already playing) its part:

• Improving cultural competence by, for example, understanding the cultural beliefs of a target population and what is needed to address misinformation or myths
• Creating patient ambassador programmes by working with people who have taken part in research to provide peer-to-peer support
• Gaining disease and patient insights by investing in epidemiology and research into disease burden
• Improving trial designs by working with the community to design trials with meaningful endpoints and logistical sensitivities
• Making a commitment and sharing plans publicly.
• With ongoing commitment and real action from the industry and other key partners, we can achieve diversity in clinical trials. This will ultimately improve the lives of people with health conditions as we work towards health access and equity for all.

Jessica Pacey is CEO of 67health