Patient groups typically under-represented in clinical research include, but not limited to, Racial & Ethnic minorities, Older adults, Children & Adolescents (Paediatric), Women, those with Disabilities & Low-Income populations.
These patient groups typically have lower participation rates in clinical trials compared to the general population. Under-representation can occur due to a variety of factors, including socioeconomic disp
arities, cultural & language barriers, limited access to healthcare, & generational distrust.
Below we discuss 3 strategies to help meet the needs & expectations of these patients.
Trial sponsors & sites can collaborate with local community organisations, patient advocacy groups, and healthcare providers to establish trust, raise awareness, and engage directly with patients. This can be in the form of virtual & physical informational sessions, workshops, and community events to educate individuals about the importance and opportunity of clinical research, as well as further information on the specific therapeutic area under investigation. Patient Advocacy groups can often provide invaluable help to trial sponsors when breaking down distrust in specific communities, as well as raising awareness for upcoming trials.
Study Design – Incorporating the Patient Voice
Involving all patient groups in the early stages of study design can prove to be incredibly valuable. The inclusion of under-represented patient groups will ensure that their unique perspective and needs are considered. By shaping the trial around the needs of specific patient groups, you can expect recruitment & retention efforts to be more successful. Examples of this would be incorporating the views of patients to aid in site selection, decentralised/ hybrid aspects, technology inclusion/ exclusion as well as patient reimbursement strategy.
Breaking Down Barriers
There are many barriers that prevent under-represented populations from participating in clinical trials. Whilst these can vary greatly, they would typically include a general lack of awareness, mistrust, transportation, financial constraints, and community/cultural beliefs. Working with patient & community groups can lead to identifying the barriers within specific patient populations, and ways to counter these. An example being, working with patient advocacy groups to review trial marketing and promotional materials to ensure it appeals to under-represented groups.
Whilst the list above isn’t exhaustive, by attracting typically under-represented patient groups to clinical research you can ensure trial results are inclusive to all patient needs, regulatory compliance (FDA recently released guidelines on this), as well as, promoting health equity.