Virtual CRO operationalizes comprehensive service to help life sciences companies meet new federal guidelines for diversity, equity, and inclusion in clinical trials
Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), announces its Inclusivity, Diversity, and Equity in Action (IDEA) toolkit. IDEA is a comprehensive clinical trial planning and support service designed to help clinical trial sponsors navigate the myriad challenges in developing and executing diversity action plans, now required by law for most clinical trials in the United States.
In April 2022, the FDA released draft guidance on improving enrollment for participants from underrepresented racial and ethnic populations in clinical trials. Now, Public Law 117-328 has taken the guidance a step further by requiring diversity action plans for clinical trials to determine drug and device safety and efficacy. The law, which incorporates the DEPICT Act, addresses decades of drug and device studies that enrolled primarily white men. This tendency has resulted in significant knowledge gaps on how treatments may affect a major portion of the population and perpetuated systemic health inequity. For example, in a 2020 study, enrollment of Black Americans in clinical trials was reported as 4.5% despite this group accounting for roughly 13% of the U.S. population and 22% of yearly cancer cases.
Curavit’s IDEA toolkit delivers support across five key functional areas:
- Preliminary Situational Analysis – a summary document consisting of information about the trial’s specific patient population needs based on therapeutic area, disease risk factors, and potential obstacles to recruitment and retention. Curavit also helps sponsors create a plan to enroll appropriately representative numbers of participants from historically underrepresented populations to be submitted with investigational new drug (IND) and investigational device exemption (IDE) applications using templates informed by the most current FDA guidelines.
- DEI Implementation Strategy – a streamlined trial execution strategy in alignment with the trial protocol and FDA diversity guidelines. Curavit provides recommendations for optimal patient recruitment methods, technologies, and partners; community/non-profit/patient advocacy partners; preferred site(s) or combination of alternative sites such as mobile units and home health networks; and tweaks to protocol designs to optimize patient enrollment and retention across historically underrepresented groups.
- Content Review – feedback on the language, design, imagery, and cultural relevance of all recruitment marketing materials (i.e., web sites, brochureware, social media posts, videos, advertising, and more). This is particularly relevant when engaging with populations from varying linguistic backgrounds and degrees of health literacy.
- Continuous Check-Ins – data analytics displayed as near- real-time dashboards to track enrollment progress versus projected milestones to continuously monitor status. Curavit offers regular check-ins, too, to help ensure sponsors can pivot quickly to mediate a problem before going too far into the process. See sample dashboard here.
- Ongoing Optimization – ongoing monitoring of patient participation throughout the life of the trial including real-time alerts to trial teams of spikes in patient dropouts and other urgent issues. Curavit will work with study teams to self-correct if faced with patient demographic concerns; even after meeting initial diversity enrollment goals and the trial is well underway.
“The life sciences industry must transform access to clinical trials so that we can bring novel therapeutics to all patients. We are motivated to produce the highest quality science, along with fairness and equity in clinical trials,” said Jackie Kent, an executive industry advisor and member of Curavit’s Board of Directors. “With its unique combination of insights, protocol development support, and planning guides, Curavit’s IDEA toolkit is helping companies turn lofty aspiration into action.”
Two early adopters of Curavit’s new service offering have leveraged planning templates to proactively ensure that they were familiar with the underrepresented patient populations that would be important to include in the trial, to compile effective strategies to recruit diverse groups of patients for enrollment, and to identify potential sites and investigators already engaged with the desired patient populations.
“Population representation in trials is a thorny problem to solve, especially for early-stage life sciences and digital therapeutics companies without major resources to invest – but for even larger companies, no one seems to know where to start,” said Joel Morse, CEO and co-founder of Curavit. “Curavit’s new IDEA service offers all companies the right scaffolding to architect a customized diversity strategy including the specialized expertise to efficiently execute that strategy.”
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