Is Diversity in Leadership the Key to Diversity in Clinical Trials

With a vast scientific talent pool, a vaster population (that can provide statistically significant numbers whichever way one cuts the population) and a cost-conscious and cost-effective infrastructure, except for the embedded inefficiencies, India is rapidly gaining prominence as a hub for clinical trials.

It is perhaps a natural progression, since it is already a major producer and supplier of generic medicines, and known as the pharmacy of the world. According to Forbes, “India supplies 40% of the generic drug demand in the U.S. and provides a quarter of all medicines in the UK. Moreover, it currently commands over 20% share of the global pharma supply chain, and addresses approximately 60% of the worldwide demand for vaccines.”

A clinical trial, for the uninitiated, is defined by the World Health Organization (WHO) as “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.”

Roles in a clinical trial

There are some established roles in a clinical trial. Johns Hopkins Medicine defines them as follows (summarized):

Principal investigator

Develops the concept, oversees all aspects of a clinical research study, such as collection, analysis, interpretation, and presentation of research results. Ultimately responsible for everything.

Study physician

Monitor and care for people who take part in the study. They evaluate and record patient responses and document side effects. 

Research nurse

Explains study details to patients, staff and health providers in the community, helps with giving the study medicines and assists the PI in monitoring for side effects.

Study coordinator

Handles many of the ongoing activities.

Research pharmacist

Ensures that research medications are delivered safely and given in the best way to evaluate effectiveness.

Participants

Participants in the clinical research are also part of the team.

Leadership

Over and above these roles is the role of the leadership team of the company or institute conducting the research.

Diversity challenges in clinical trials

There has been growing concern in the US that clinical trials do not adequately represent the population the treatments are intended for. To state the same thing more directly, trial participants in the US are usually predominantly white, even for drugs that address diseases that disproportionately afflict non-white populations.

Increasingly, the conclusion being reached for this state of affairs is the lack of diversity at the leadership level. This, in turn, results in comfort with the extant state of affairs and influences decision-making and priority-setting. Findings from a 2022 BIO report:

• Black professionals made up 6% and Hispanic/Latinx professionals 7% of the total workforce. Their presence in executive roles was even more limited, with Black individuals representing 3% and Hispanic/Latinx individuals 4% of executive positions.
• While women accounted for 49% of the total biotech workforce, their representation decreased at senior levels, with 34% on executive teams and only 20% serving as CEOs.

India can learn from the experience of others

As clinical trials gather pace, India can benefit from the experience of others and avoid the pitfalls that may have limited the efficacy of clinical trials in other geographies. It may not have racially distinct population groups as in the US, but in a continent-size nation, there is a wide variety of genetic pools through its length and breadth; urban and rural, eco-climactic zone based, tribals and ethnic groups such as in the Northeast, caste-based segregations, differences based on religion and food habits, and even uncontacted populations such as in the Andaman and Nicobar Islands.

That being said, it is often pointed out that clinical trials in India suffer from similar, if not the same biases as in the US. For one, big-city-based pharma companies tend to favour urban populations for trials. They are also accused of concentrating on making up numbers that provide statistical validity, rather than ensuring adequate representation of different gene pools.

Knowing what we do about the West, can India sidestep these issues by investing in a more diverse team to conduct the trials and, perhaps even more importantly, a diverse leadership to promote equity, fairness and effectiveness in clinical trials?

The technical competence that the traditional male, urban, premier institute-educated leadership profile brings is definitely needed, but it has become table stakes now. Pharmaceutical companies realize that they need to go beyond and explore new ways of serving the most vulnerable populations, like by ensuring effective, representative clinical trials.

Your search partner can be your strategic partner

Established search firms like Ushankk are playing the role of a catalyst in transforming the leadership pipeline in pharmaceutical companies engaged in clinical trials in India.

Ushankk can help you with broadening your leadership talent and tracking and sharing global experience in this area. It can be your strategic partner in making the world healthier as you go about your business of making India a hub of global clinical trials.