< Back to Clinerion Expert Corner
By Daniel Gutierrez, Ph.D
The European Union and the USA’s FDA have recently encouraged diversity and inclusion in clinical trials.(1,2) The FDA has issued guidance documents stressing the need for a diverse population in clinical trials, as well as how to achieve this. In particular, they endorse diversity and inclusion in areas ranging from racial and ethnic backgrounds, to genders, ages, and medical conditions in their recommendations. Europe is making it particularly important to include a representative sample of the population.
This article addresses the benefits of diversifying clinical trials, the challenges of doing so, and how real-world data (RWD) can help. RWD can be a powerful instrument to deploy strategies for improving diversity and inclusion in clinical trials, for example, optimizing data collection, analyzing data to identify potential participants, addressing barriers to participation in clinical trials, or ensuring sustainable inclusions and representation.
The Benefits of Diversifying Clinical Trials
Diversity in clinical trials is essential for understanding the impact of treatments and ensure that new therapies are effective and safe across a variety of populations. A diverse group of participants allows any observed differences in the effects of a drug to be attributed to biological, as well as social and cultural factors. It is, therefore, important to identify and include potential participants from different ethnic backgrounds, as well as from different socio-economic groups who potentially have their own unmet medical needs.
Including a diverse group of participants in clinical trials also helps to ensure that the results of the trial are applicable to a wider range of people during commercialization. This is especially important considering patient mobility and the effects of immigration on a country’s sample population.
Understanding the Challenges of Diversifying Clinical Trials
We all know that patient recruitment is expensive and time-consuming. In addition, due to cultural or socio-economic factors, some participants may face barriers to enrolment. For example, patients who are shift-workers may not be able to take time off. Other potential participants may not be aware of the possibility of participating in clinical trials due to complexity of the topic, or face language barriers which could automatically exclude immigrants that don’t speak the local language from the trial.
It is important to ensure that clinical trial staff are aware of and sensitive to cultural differences to create an inclusive environment for potential participants.
How Real World Data Can Help Increase Diversity in Clinical Trials
RWD is data collected outside the controlled environment of the clinical trial setting, such as patient medical records, surveys, and claims data. This data can provide valuable insights into the population of potential participants and can be used to identify and recruit participants who are traditionally underrepresented in clinical trials. This can increase diversity in clinical trials, which can lead to more accurate results and better medical outcomes.
For example, researchers were able to design a clinical trial to test the effectiveness of a new drug specifically in African American patients with heart failure. The results of this trial showed that the drug was effective in reducing mortality rates in African American patients, demonstrating the potential of RWD to improve clinical trial outcomes.(3)
Using real-world data to increase the diversity of candidate drugs during development can also help reduce the cost of the final, launched drug for pharma and patients. For example, an analysis by Gerlinger et al presents a straightforward approach to “assess the potential absolute clinical and economic benefit of a new drug based on real-world data and its target product profile. The approach allows for early data-driven portfolio decisions to select drug candidates based on their expected cost savings.”(4)
The latter article demonstrates that leveraging RWD helps plan and make decisions ahead of commercialization.