New report shines a light on the under-representation of older people in clinical trials
RBW Consulting, a recruitment and search consultancy specialising in the life science sector, and The International Longevity Centre (ILC), have today unveiled a new report that delves deeper into the topic of age inclusivity in clinical trials.
The Trial and error report urges regulators, pharmaceutical companies and researchers to prioritise age diversity at all stages of the clinical trial process. Informed by in-depth expert interviews and a roundtable discussion, it explores the reasons for the lack of representation of older people in clinical trials and includes eight recommendations to ensure improvements are made.
It is RBW's second initiative under its innovative IMPACT programme, which sees the consultancy invest in patient-focussed projects where there is a shortage of knowledge, data, discussion or practical implementation on important issues within the health or life science sector. It follows RBW's 2021 ‘Emotional Odyssey’ initiative, which focused on the psychological impact of rare disease diagnoses in partnership with Rare Disease Research Partners (RDRP).
The report outlines a number of reasons that contribute to the lack of age diversity in clinical trials, including added costs and arbitrary exclusion. Eight practical solutions were proposed and discussed in more detail in a launch webinar hosted by RBW.
Emma Thorp, Chief Commercial Officer at RBW Consulting, a certified B Corp company specialising in life science search and recruitment who provided support for the project as part of their ongoing CSR programme, said: “We are proud to have partnered with the ILC on this project. Against the backdrop of the United Nations decade of healthy ageing, it felt like the right time to drill down into the needs of older people as part of the movement to make clinical trials more representative.
It’s our hope that this work will support our clients and the industry in general with inclusive trial design. The more we can identify and share practical solutions, the more progress we will make, and our hope is that this work will sit alongside the excellent efforts of others to make real change happen.”
The report’s publication comes just weeks after significant legislative and policy proposals were announced on both sides of the Atlantic. The American Food and Drug Administration’s (FDA) published proposals to require diverse plans from researchers in order for clinical trials to be approved. At the same time, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced a series of legislative changes designed to streamline clinical trial applications. Guidance will accompany this change in legislation, outlining how trials can "include patients meaningfully into the design and conduct of trials" and "achieve diversity in trials in a way that is proportionate and achieves the best results."
Esther McNamara, Senior Health Policy Lead at ILC and author of the report, explains: “This issue has rumbled on for many years; regulators, patient groups, researchers and pharmaceutical companies agree that a concerted effort is required to include more older people in trials. These are the very people who can make sure that the best treatments are found for the conditions that affect them most. We spoke with a range of expert stakeholders to reach conclusions and make recommendations in our report, which, if implemented, could support huge changes that better serve older patients.
These new initiatives by the US and UK government agencies are timely, but we urgently need guidelines for clinical trials to put age diversity on a par with gender and ethnicity. We make recommendations in this report that affect stakeholders at all stages of the trial process. Only once these changes have been made will clinical trials generate the evidence that older patients deserve when they are prescribed medicines.”
The full report can be downloaded here.