Valuing Clinical Trial Design

The global scientific community is committed to reducing biases in clinical research, and while the situation is improving, there is still a lot of work to be done to foster inclusivity and diversity, according to Filomena Ribeiro MD, PhD, president of the ESCRS.

“Historically, many clinical trials have been dominated by participants from specific demographic groups, and these often exclude diverse populations, such as ethnic minorities, women, or older individuals,” Professor Ribeiro said.

A lack of diversity in the patient recruitment process can arise from systemic barriers which prevent them from participating in clinical trials, such as limited access to healthcare due to transportation or climate issues, mistrust in medical science, or language barriers. Bias and exclusion can also affect investigators.

“Lacking figures from underrepresented groups, in a non-intentional way, can have an impact and influence on the design of studies, recruitment strategies, and interpretation of results,” Prof Ribeiro said.

Diversity and inclusion in clinical research really matter—the consequences of their shortage can have a huge impact on the clinical research itself.

“It can be a limit to the ability to generalise our findings on the research,” Prof Ribeiro remarked.

She pointed out that the scarcity is in the non-heterogeneity of the population—not considering specific subgroups—which affects the safety and effectiveness of the object under study. For example, the ophthalmological community is already aware ethnicity, gender, and age impact the modelling for IOL power calculation and that there are some anatomical and treatment reaction differences in eyes from different geographic areas.

This bias could also lead to some problems when artificial intelligence is applied to provide insights on treatment since these programs use existing data sets. If clinical trials suffer from some biases, these can be transferred to algorithms, generating models that consider only a part of the population. Luckily, several developments are in place to avoid biases in information on clinical trials using AI, Prof Ribeiro explained.

However, she noted greater sensitivity on the topic arrived during the COVID pandemic, and the EMA and the FDA have begun to address it through global guidelines to encourage diversity, community engagement, and building trust in the research process.

While a good start, Prof Ribeiro believes more strategies and efforts should be put in place to tackle issues that prevent a more inclusive research process. For example, there should be a particular focus in reducing logistic barriers, offering more decentralised trial options, providing financial support for transportation, or supplying materials in different languages. Research teams should be more diversified, with investigators trained to recognise possible existing biases. Researchers also need to model the results to have an appropriate representation across ethnic, gender, and sociodemographic dimensions and combine them to improve treatment safety and efficacy of treatments—which she said is true not only for pharmaceuticals but also medical devices.

Enhancing and fostering inclusivity can lead to improved quality in scientific research, increasing its applicability and ensuring findings are more representative of the broader population.

“This leads to more equitable healthcare solutions, and we can determine how treatments work for different groups, ensuring better outcomes for everyone,” Prof Ribeiro concluded. “Inclusivity builds trust in science, and as doctors and researchers, we want to serve the whole community, so we need to have this commitment.”

Filomena Ribeiro MD, PhD, FEBO is head of ophthalmology at Hospital da Luz, Lisbon, Portugal, and ESCRS president. filomenajribeiro@gmail.com