From inclusive clinical trials to diversified data, we must accelerate in the race to health equity
A great deal has changed since my time as a doctor in London. Of course, the speed and scale of transformation varies from country to country. In the UK, for example, healthcare continues to be very cost- and payer-driven, which can lengthen the time taken to get new medicines to patients. But, by and large, there's been considerable progress across many therapeutic areas in terms of both diagnostics and treatments.
During my time practising lung cancer oncology (a while ago!), we'd just got to the point of developing treatment pathways that distinguished between non-small cell and small cell lung cancer. Yet now, clinicians are able to pinpoint different subtypes, mutations and modalities. For me, this represents a whole new ball game, opening the door to creating truly targeted treatments.
Such progress is critical to achieving our mission at Janssen – to tackle areas of high unmet medical need – and it's exciting to think about the breadth of diseases we hope to be able to treat in the not-too-distant future. From maternal foetal disorders and genetic eye conditions to dengue fever and infectious diseases, conditions that were once untreatable, could soon become manageable, even curable.
Yet diversity in healthcare means more than just the number of diseases for which we have treatment options. In an ever-more globalised society, the issue has a fundamental human element too. Part of that involves talking more about hidden diversity within our own organisations – a particular passion of mine. But, beyond that, if we're to truly ensure no-one is excluded or left behind in the healthcare systems of tomorrow, we must give every patient, everywhere a voice in the development of new treatments and medicines today.
Having a diverse range of participants in clinical trials, including racial and ethnic minorities, the elderly and women, is key to this at every stage of development. In the US, the Food and Drug Administration (FDA) issues strong guidance about patient categorisations and the number of representatives from each category that must be entered into clinical trials. This is helping diversify the data available when assessing the efficacy of new treatments.
Yet in Europe, this approach has been resisted due to concerns around data privacy. For example, ethics committees have previously expressed concerns about the purpose of collecting and retaining diversity and ethnicity data. Yet while frameworks to address this, such as the General Data Protection Regulation (GDPR), are in place for good reason, we must recognise they can also be a significant barrier to diversity. If health information isn't shared, it limits how we can investigate, monitor and treat diseases, especially those with high unmet need and those with small patient populations.
Put simply, homogenous data is of little use if we're to gain a thorough understanding of disease progression and likely drug response across a diverse patient population. So as healthcare organisations, we must work hard to expand our research and development programmes to reach a wider range of geographies and demographics. We must partner with policymakers to balance their security concerns with the need for progress. And, crucially, we must be honest about the barriers data privacy laws can present for treatment innovation and do more to explain how sharing data can aid progress so long as it’s in trusted hands.
There are, of course, other barriers to diversity besides privacy concerns. Some understudied and underrepresented groups continue to be put off from enrolling in clinical trials by fear, mistrust or cultural stigmas around participating. Others are held back by geographical, economic and logistical constraints or a lack of communication with clinical researchers.i In each case, we have to identify the specific issues affecting different demographics and communities, then work together to overcome them.
For example, Janssen recently took steps to make one of our clinical trials more inclusive, using demographic data to identify and use clinical sites located in diverse communities. This successfully attracted nearly 44,000 participants from eight countries, taking in a wide variety of ethnicities and underlying medical conditions. Our task now is to build on the successes and lessons from that trial to confront underrepresentation in other disease areas and, in doing so, develop treatments that are safe and effective for everyone.
Ultimately, we must reach a point where both the desire and the mechanisms are in place to make healthcare truly inclusive and equitable all over the world. This is why I'm pleased to have been invited to participate in the European Council's Health Inequities Network to raise the topic of inequity in clinical trials – something there is a unanimous wish to address among all the Network's participants.
My hope is that this will be another positive step in Janssen's commitment to helping create a future where all patients have access to the medical care they need – regardless of who they are, what their background is or where they live. The world's healthcare challenges are ever-more diverse. We can only hope to solve them if we know we're including everyone and act to address all inequities we find.
 Hamel, L.M et al. 2016. Barriers to clinical trial enrolment in racial and ethnic minority patients with cancer. Cancer Control. 23 (4): 327-337.