Bridging the Gap: A Viewpoint on Including Underserved Communities in Clinical Research – Needs and Recommendations for Action

Clinical research plays a key role in the healthcare continuum. Ensuring diversity, equity and inclusion is the key to enhancing the quality. Underrepresented groups can be categorised based on various characteristics: Demographic factors, socioeconomic elements, etc. Inadequate representation of underrepresented communities in the Severe Acute Respiratory Syndrome Coronavirus 2 vaccine trial led to diminished confidence regarding vaccine safety and effectiveness, ultimately affecting vaccine acceptance among crucial underrepresented groups who potentially had the most to gain. The omission of individuals with cardiac conditions from lamotrigine trials and the exclusion of patients with neuromyelitis optica from the optic neuritis treatment study led to inadequate treatment for these groups for decades. This calls us to the entire paradigm that the clinical trials are built on and diversifies the inclusion criteria to serve underrepresented communities. Various national entities are spearheading initiatives. Notably, the UK National Institute for Health and Care Research has developed the INCLUDE guidelines, which offer valuable inquiries to assist researchers, funding bodies, evaluators and research implementation teams to improve inclusion. It can be used by all institutions while developing protocols for study. After a series of literature searches, a series of 10 recommendations is proposed to improve inclusion and achieve health equity and diversity in clinical research. To effectively implement evidence-based practices, it is essential to minimise bias and inequality in the evidence generation process. The benefits and opportunities associated with clinical research should be accessible to all, not just a privileged few. Ensuring such inclusivity is a shared, global ethical obligation.