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Clinical Trials Q2 2022

How we’re working to achieve equality, diversity and inclusion in clinical trials

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Dr Jennifer Harris

Director of Research Policy, ABPI

The pandemic has brought into sharp focus the health inequalities that currently exist in the UK, with some communities affected significantly worse by COVID-19.

The pharmaceutical industry is well placed to play a key role in helping to tackle the issue of health inequalities.

A key mechanism for doing this is ensuring that the evidence generated through clinical trials is more inclusive and informs healthcare decision-making. We’re working on a number of fronts to make this happen.

Collaboration with partners to develop guidance

The ABPI partnered on the National Institute for Health Research (NIHR)’s INCLUDE project, which has co-designed guidance to summarise what an under-served group is and guide funders, researchers and delivery teams in how to design research to be more inclusive.

Building on this and focussing specifically on race equality in health research, the NIHR Race Equality Public Action Group has also recently published a framework to assess how to better serve diverse communities. Health research organisations from across the sector, including industry, took part in a three-month pilot, which helped inform the development of this framework.

Our response to the MHRA’s consultation on clinical trial legislation stresses the importance of regulatory support for improving diversity and inclusion. It also emphasises the value of patient and public involvement in clinical trials. We have offered our support in co-developing guidance for researchers and sponsors.

The Health and Care Act, introduces a new requirement for integrated care systems to facilitate or otherwise promote research,

The opportunity of integrated care systems

The establishment of Integrated Care Systems (ICSs) in England is an opportunity for parts of the system to work together to prevent disease and improve the health of the populations they serve.

Following Royal Assent of the Health and Care Bill, the ICSs will have new responsibilities to drive the research agenda across primary, secondary and tertiary care settings. This is a major opportunity to unlock greater community engagement in research across the NHS and help diversify clinical trial participation.

The Health and Care Act introduces a new requirement for ICS’s to facilitate or otherwise promote research. We look forward to supporting this strengthened mandate as the ICSs prepare to go live.

The establishment of the ICSs is a once-in-a decade opportunity, and one we need to grasp with both hands if we are to be successful in leveraging the nation’s research and innovation ability to tackle health inequalities.

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