RCT data is the corner stone of drug development, however, proposed patient groups are rarely homogenous in nature and patient groups, payers and regulators are increasingly demanding that companies accurately reflect this heterogeneity in RCTs, increasing the accuracy of outcomes and the predictive nature of the risk-benefit profile of an approved drug, especially in under-represented demographic groups. There is emerging evidence that race, ethnicity, age, sex and gender can influence the risk:benefit profile of a drug in terms of effectiveness v adverse drug reactions, which can be governed by pharmacogenetics. It is important nuances within subjects are identified early in the drug development pathway, and this includes the utilization of tools available to ensure you capture data from a diverse pool of individuals. Firstly, life science companies need to address historical mistrust in clinical research, which is still prevalent in some communities as evidenced by the issue of vaccine hesitancy throughout the Covid-19 pandemic, in underrepresented ethnic groups, who also suffered disproportionately higher rates of death and mortality. How we use technology has gone through a paradigm shift, with telemedicine and remote monitoring becoming necessary during the pandemic (decentralized trials). Herein lies an opportunity to capitalize on digitalization, alleviating patient burden (e.g. non-invasive monitoring), developing culturally-specific communication (e.g. e-consent), bringing the trial to the patient (e.g. reducing travel costs), increasing the diversity of participants. There is also an opportunity to leverage cross-border regulatory efforts, accepting more inclusive real-world trial eligibility criteria, especially regarding laboratory cut-offs that disproportionality affect communities with higher incidences of co-morbidities – associated with lower socio-economic status. The onus is now on stakeholders to bring the trials to these patient groups.

Diversity, Equity, and Inclusion (DEI) in Clinical Research – a Paradigm Shift

For it's 35th anniversary, DIA Europe is back in Basel, where all thought leaders meet in person to discuss, inspire, and network.

Join us in Basel: March 22-24, 2023

DIA Europe 2023 is designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need for your everyday job. Your participation will accelerate your growth and your organization's performance in the drug development ecosystem.

Gathering innovative thought leaders from the entire life science landscape, DIA always has the aspiration to be ahead of current developments, reflected by 4 new content tracks in 2023:

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DIA Europe 2023

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.