Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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SEARCH JOBSEfforts to make clinical trials more diverse received a potentially game-changing boost from the US Food and Drug Administration (FDA). In April 2022, the FDA released another guidance on diversity in clinical trials – this time with a clear focus on upfront planning and goal setting earlier in development.
The draft guidance, entitled Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials, expands on an existing but lesser-recognized 2016 recommendation that sponsors submit a Race and Ethnicity Diversity Plan for discussion before starting Phase III.
The 2022 draft guidance outlines the content and format expectations for these plans, providing the clarity sponsors have been seeking and reinforcing efforts within sponsor organizations to improve the representation of racial and ethnic minorities in clinical trials.
The issue of diversity in clinical trials and industry efforts to address the representation gap is not new. Our industry and other stakeholders have spent decades working on this issue and investing millions of dollars in programs and initiatives to help at the community, patient and site level, yet measurable, consistent progress has been elusive.
Too often, clinical trial diversity efforts have fallen short because diversity isn't thought of – or focused on – until after site selection and start-up - and when all the ‘machinery’ that runs massive phase 3 trials is already in action. Adding programs and new materials during recruitment is too late, ineffective, costly, and reinforcing beliefs that diversity goals mean added time and cost.
IQVIA has been advocating that the opportunity for real progress is at the operational level – where proactive and intentional goal setting, embedding diversity into the planning and execution of the trial and carrying that focus through site selection, start-up, recruitment and retention – along with close monitoring of progress can enable diversity goals to be achieved in concert with all trial goals, including timelines. We’ve built our Trial Lifecycle Approach to Diversity with this in mind.
Our trial lifecycle approach was designed several years ago based on our understanding of FDA expectations and intent, balanced with sponsor needs and concerns.
Like the guidance document, our approach starts with identifying demographic goals as part of the trial plan, validated by an epidemiological analysis of the demographics of the patient population. E.g., if 18% of the known patient population for the targeted disease are Black/African American, then ideally, the patients enrolled in the trial should be at or near 18% Black/African American. We also apply a diversity lens to protocol design, site selection, site and patient training, recruitment and retention strategies, and leverage data, technology and analytics to keep on track and adjust course where needed.
During the pandemic, we saw many sponsors meet or exceed diversity goals while staying within tight budgets or timelines. In one study conducted by IQVIA, a large pharma company recruited more than 40,000 patients to a vaccine trial in just eight weeks while exceeding its diversity goals. Their success resulted from upfront planning that included diversity-informed site selection, clear goal setting with individual sites, targeted outreach efforts and careful monitoring of the recruiting funnel to ensure diverse populations had the chance to participate.
When sponsors make diversity goals part of the plan from the start – rather than a goal added at the last minute – they can make adjustments that improve access and appeal of trials for diverse populations. These can include choosing more sites in diverse communities, leveraging technology to reduce the burden of participation, working with sites to support their understanding of goals and engagement with diverse communities and conducting community outreach and advertising campaigns designed to address concerns and preferences of diverse participants.
By providing clarity on the format and contents desired in Diversity Plans, the FDA has essentially given sponsors the playbook and incentive for thinking ahead.
Goal setting will still bring up concerns about potentially constraining and thus delaying enrollment, but sponsors should take comfort in the wording in the guidance. The FDA signals that planning, intentionality and mid-stream mitigating efforts will be considered if sponsors fall short of their goals. This middle ground should provide study teams with confidence to identify and commit to what good looks like – ahead of the trial.
The combination of the FDA's new guidance, recent successes and industry investments, and focus on diversity is creating momentum within the broader trial ecosystem and giving diversity advocates within companies a platform for influencing functional leaders to make diversity part of the plan.
With more planning and focus from the start, we expect to see many more examples of sponsors meeting diversity goals alongside overall trial goals – and gaining the confidence to make diversity business as usual.
To learn more about IQVIA's Trial Lifecycle Approach or the DICT Initiative, contact us, or visit our website at https://www.iqvia.com/solutions/research-and-development.
IQVIA is dedicated to helping ensure clinical trials are more accessible and inclusive. We recommend a proactive approach that begins at trial planning by incorporating the clinical and demographic characteristics of the intended population. Factoring insights and established goals into site selection, site training, and the recruitment strategy, accompanied by close monitoring throughout recruitment and trial conduct.
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