The top priority of life sciences organizations is ensuring the safety and efficacy of new clinical treatments in order to improve the health of the individuals and communities they serve. Naturally, the effectiveness of clinical trials hinges on compiling and analyzing data that accurately reflects the target population.
For this reason, participant diversity must be ensured when executing clinical trials, not just for scientific benefits, but also for moral purposes. When a clinical trial participant population consists of individuals from similar backgrounds that largely share the same ethnicity, race, and gender, it limits our understanding of which treatments and medicines are effective for population subgroups. In turn, these subgroups are further marginalized and put at a disadvantage when it comes to receiving safe, effective medical treatment.
The under-representation of racial and ethnic minorities in clinical trials in the United States is too staggering to ignore.
In the wake of this disparity, participant diversity is no longer an aspiration for organizations to work towards— it’s a matter of urgency.
One of the greatest challenges facing clinical trials today is the timely recruitment of participants. Recruitment delays can lead to lost potential revenue ranging from $600,000 to $8 million per day per drug. There is a myriad of reasons clinical trial managers struggle to recruit diverse trial populations, including:
■ A lack of awareness and education around the opportunity to participate.
■ Limited proximity to research sites. More than 70% of the U.S. population lives more than two hours away from a research site.
■ Protocol requirements that are too disruptive to those already burdened by disease.
■ Socioeconomic factors such as the disproportionate burden of childcare make women harder to recruit
The global pandemic only accentuated these problems.
In an increasingly digital world, where working with a participant population that accurately reflects those most affected by the diseases you’re researching is essential, life sciences organizations need new data-driven recruitment strategies to overcome diversity barriers.
Lack of diversity in clinical trials isn’t just a recruiting problem—it’s a data problem. Get the full article
Luckily, the emergence of modern, digitized clinical data management platforms presents a tremendous opportunity for life sciences organizations to gain efficiencies, ensure the efficacy of new treatments, and positively impact the trial participant experience.
In this ebook, we will examine the role data and real-time analytics play in ensuring life sciences organizations are able to support diversity and inclusion goals for improved trial outcomes.
The ability to rapidly reallocate resources as needed and act on real-time participant information is a critical step in overcoming diversity challenges.
Today more than ever, clinical development is a data-driven industry. As clinical trials become increasingly decentralized and complex, many life sciences organizations are struggling to scale sufficiently to handle the volume and variety of data that continues to proliferate. Instead of trying to adapt, patch, or modify legacy systems to account for modern-day challenges, organizations must develop an innovative data infrastructure and ecosystem that simplifies the process of organizing and managing diverse data streams.
The need for comprehensive data analysis has become even more pressing since the Diverse and Equitable Participation in Trials (DEPICT) Act was passed in February 2022. The DEPICT Act seeks to boost diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics, and requires clinical trial managers to provide resources that improve access to clinical trials. The recently passed legislation states that:
■ Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants must report clinical trial enrollment targets by subgroups such as race, ethnicity, and sex and provide the rationale for those targets.
■ The FDA will have the authority to mandate post-marketing studies when sponsors do not meet diversity enrollment targets without good reason.
■ The FDA will publish an annual report aggregating and analyzing data provided by sponsors on progress towards goals for increasing diversity in clinical trials.
Further important DEPICT clarifications are:
How sponsors should submit a “Race and Ethnicity Diversity Plan” with applications proposing clinical research, or continuing with trials to support the approval of drugs, biologics, and medical devices.
Sponsors must set enrollment goals for a full range of populations in order to obtain relevant pharmacological and genomic data that can help design larger studies appropriately.
AND importantly have participant retention strategies, which may involve collaboration with community health workers and patient advocates and reimbursement for expenses to participants in need.
To fulfill these goals, access to near real-time data and analytics is more crucial than ever to ensure you are delivering to your plan.
Sponsors must develop and disseminate actionable and scalable solutions to promote the goal of diversity in enrollment, and to facilitate subgroup analysis in clinical trials.
Starting to address recruitment challenges for clinical trials means first understanding that these issues stem from data problems. For life sciences organizations to become truly datadriven businesses that can keep up with the volume and complexity of clinical trial data, they must work from a modern clinical data platform that automates the data pipeline across source systems and serves as a foundation for all participant insights.
With more than 200 employees and ten programs in its drug pipeline, Cerevel Therapeutics needed a comprehensive data management system that was compatible with the quick pace of their team and sophisticated processes. But their reliance on SaaS providers and cloud-based technologies made it hard for them to provide oversight, keep track of participants and adverse events, and meet the goals outlined in their Diversity, Equality and Inclusion (DEI) guidebook.
Cerevel was looking for the perfect harmony of game-changing technologies built specifically for the clinical space. Their search led them to eClinical Solutions. Through enhanced mapping and streamlined ingestion of data, Cerevel used eClinical to better monitor site recruitment and foster greater diversity among enrollees in its clinical trials.
Following the development and rollout of these tools, our clinical team was able to look at data in real-time. We can now look at the demographic data for participants and patient populations relative to our global sites. If we think we’re lagging in a certain study or certain geography, our clinical study teams can have discussions about it sooner rather than later and correct the issue. We are better able to select sites to conduct studies.”
Learn more about how Cerevel developed a diversity, equity, and inclusion (DEI) Guidebook to assist it’s clinical teams. Dr. Versavel states a diversity guidebook will help sponsor teams think about diversity throughout the life cycle of a clinical trial, from design through to planning, startup, implementation, and closeout and the role of technology to help it monitor site recruitment and foster greater diversity among enrollees in clinical trials. Get the full article
Dr. Stacey Versavel, PhD, Senior Director of Clinical Operations, Cerevel Therapeutics
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Let’s say an organization is looking to compare data on Covid-19 cases by city with upcoming study dosing visits by site level. The sponsor organization wants to ensure that their upcoming trials won’t be delayed or negatively impacted due to people being unable to safely participate. Through real-time analytics, clinical teams can quickly see where Covid cases are most prevalent, and deploy home health care workers and other resources to the necessary locations accordingly. In turn, participants have the care and resources they need to remain enrolled in the study, while the life sciences organization avoids costly delays. This type of rapid decisionmaking is made possible through the use of an effective analytics strategy. Supporting your diversity goals is an ever-evolving initiative, as legislation like the DEPICT Act and global factors such as the pandemic continue to change the game. Through accurate and accessible clinical trial data supported by an automated analytics infrastructure, biopharmaceutical companies can streamline their decisionmaking processes and ensure they’re able to remain flexible and agile as their trials progress.
Ultimately, your organization is striving to improve the health and well-being of people in need. Not only does the right clinical data management system enable you to work smarter, faster, and more confidently throughout your clinical trials, but it also ensures your participant population accurately reflects the people you hope to serve with the new therapy.
The importance of a modern clinical data platform, such as eClinical’s elluminate®, demonstrates to regulators how you, as a Sponsor, will ensure appropriate oversight, and provides reassurance that every effort has been made to meet the desired recruitment goals. Near real-time data analytics and visualizations from a single source of truth of all your data allows you to focus on the issues that really matter, so you can make impactful decisions at speed. This is especially important when working in an outsourced model, where multiple CTMS are being used, or when using manual trackers.
“The time to value with elluminate was much shorter than the other products we looked at. This product best matched our cloud architecture and use of managed services, and also provided services such as the mapping and ingestion of data which allowed us to quickly make use of the product. With our cloud-based tools, data standardization, and technology, we can quickly answer any questions that arise.”
Raising awareness of the importance of diversity, greater corporate responsibility to ensure engagement with underrepresented communities are important to drive change.
Regulators expect the broadest and most diverse populations to have access to participate in clinical trials. Sponsors must develop, and disseminate actionable, and scalable, solutions or tools, to promote diversity enrollment goals and to facilitate subgroup analysis in clinical trials.
Are your oversight tools fit for purpose?
Learn how elluminate elevates the way your clinical trials manage — support and meet — diversity & inclusion goals goals by scheduling a quick demo today.
Dr. Stacey Versavel, PhD, Senior Director of Clinical Operations, Cerevel Therapeutics