Diversity has become one of the biggest talking points within the clinical trials sector, as companies look to create drugs that can benefit the wider global population.
This push has seen key global regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) create trial diversity frameworks, which aim to enhance the participation of underrepresented groups within clinical studies.
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This push includes greater female participation, but the World Health Organization (WHO) has further urged clinical trial operators to include pregnant and gender-diverse patients in their trials.
While there has been an increase in recent years, Maria Rigoroso-Brandt, global patient engagement lead at Pfizer, speaking on a panel at Arena International’s Outsourcing in Clinical Trials DACH 2025 conference, noted that what has been achieved is “still not enough”, and that more progress needs to be made.
Sex-related differences a key consideration
Panellists agreed that sex-specific considerations are key when designing trials due to strong differences in the pharmacokinetic (PK) and pharmacodynamic (PD) responses to drugs exhibited by men and women.
In addition, panellists noted the applicability of this concept in symptomology, as women often experience different disease-related symptoms than men. This means that separate medications may be required to manage them effectively in the respective sexes.
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By GlobalDataThe same trend is observed when looking at a drug’s side effects, which can differ depending on the sex of a recipient. During the discussion, panellists agreed that all these factors should be considered during the clinical development process to promote equity.
Overcoming equity barriers in clinical trials
While there has been some movement towards widespread representation and equity in clinical trials, panellists noted that there are still some barriers to overcome.
Rigoroso-Brandt commented: “Leading agencies, including the EMA and the FDA, have issued frameworks and guidance on equity in clinical trials,”
“However, governance and implementation of these guidelines is varied at both the regional and institutional levels,” added Rigoroso-Brandt.
Alongside the variable implementation of such policies, she highlighted the lack of standardisation seen in framework utilisation, which is leading to gaps in clinical knowledge.
Aside from regulatory frameworks, there were also concerns raised around the use of AI technologies, which have the potential to perpetuate healthcare disparities due to the reinforcement of historical inequities.
Actioning equity improvements
While barriers to true trial equity remain, Rigoroso-Brandt notes that good data can help bridge this gap: “Gender data analysis is a must; it should not be an afterthought anymore. We need to contribute to the strengthening of the available data.”
Rigoroso-Brandt also touted the benefits of engaging with patient organisations, as they can help companies understand the impact of a condition on specific patient populations.
She said: “It’s very important to understand the social representation of patients, as this will impact the decision of which treatment is right for a specific group.”
“It all stems down to how a drug impacts the patient, and what better way to understand that than to start assessing this during a clinical programme.”
