David Spears (Former) Partner, US Health Hall & Partners Health
David brings 14 years’ experience and accumulated wisdom in applying innovative research approaches to deliver highly practical insights and solutions to pharmaceutical companies.
When the US Food and Drug Administration (FDA) declared 2016 the ‘Year of Diversity in Clinical Trials’, they shed much-needed light on a long-standing challenge for pharma manufacturers: the demographic composition of clinical trials doesn’t always represent the full patient populations that will rely on new medicines. Rising to the challenge was Novo Nordisk, a leading global manufacturer of diabetes medicines. Together with Hall & Partners, the company studied why some patients do not participate in clinical trials – yielding potentially powerful insights.
The fight to increase diversity in clinical trials isn’t new. The National Institutes of Health (NIH) has long restricted its funding to studies to ensure the inclusion of enough minorities and women, to help determine whether they respond to treatment differently.
But NIH-funded studies represent only 6% of all clinical trials. The FDA’s new initiative called upon the pharma industry – the funding source for nearly half of clinical trials – to play a larger role by executing a new, detailed clinical trial diversity action plan.
As a leading manufacturer of diabetes medicines, Novo Nordisk recognises that the need is urgent. According to a recent publication in The Lancet, less than 5% of participants in five of seven cardiovascular-related diabetes clinical trials are African American – lower than the 13% of African Americans who have Type 2 diabetes. Novo Nordisk’s Clinical Trial Management function embarked on a programme to develop fresh initiatives for engaging with physicians and patients to increase clinical trial diversity.
As part of this effort, Novo Nordisk commissioned Hall & Partners in 2016 to talk to people with a variety of health conditions – seeking to better understand their social, emotional and practical barriers to clinical trial participation. The portrait of patient experience that emerged was clear and sharply instructional. To increase diversity, pharma must increase both basic awareness and trust within diverse populations.
In their interviews, people of colour exhibited a general wariness of the medical industry. They described clinical trials as “scary”, associated them with feeling like “guinea pigs”, and sometimes referenced the shameful legacy of African Americans and the Tuskegee Experiments. But the study didn’t find these misgivings to be the main obstacle to participation. Participants didn’t feel they were either made aware of or invited to take part in clinical trials. Existing outreach hadn’t reached them, hadn’t spoken to their experiences, and hadn’t explained the benefits of participation.
With these insights, Novo Nordisk gained a valuable sense of direction on how to improve the clinical trial recruitment experience and attract more diverse populations. To succeed, recruitment must be smart, targeted, timely, and relevant – with patient experience at its centre. Companies must analyse patient data proactively to tap into the right doctors, employ a targeted local channel strategy, and create digital campaigns that can turn routine information searches into recruitment opportunities.
While pharma has plenty of work to do, the research ultimately uncovered good news – the power to transform the FDA’s ‘Year of Diversity’ challenge into enduring practices. Diverse populations are open and waiting to be included in clinical trials. All they need is to be informed about opportunities to join, to understand the high quality of care they’ll receive, and to know how much their presence is valued.