The FDA Omnibus Reform Act (FDORA) impacts clinical research in many ways — from decentralized trial guidance and digital health technologies guidance to BIMO inspection updates and changes to the accelerated approval process. One of the most significant impacts, however, is the new FDORA diversity action plan requirement.
Diversity action plans are now a requirement for clinical trial sponsors, including Phase III, pivotal, and some device studies. FDORA also expands the FDA’s diversity focus beyond race and ethnicity to include other demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity. With these factors now codified into law, optimized hybrid and site-less clinical trials are the most straightforward path for sponsors to align with the new FDORA requirements.
Tap Into Healthcare-First Site Networks
A great first step toward clinical trial optimization is tapping into an established network of healthcare-first sites that enable you to connect with medical care facilities and the patients who already know, trust, and frequent them. An effective network will be able to identify a large selection of the best-qualified patients who meet your study requirements at area hospitals, doctor’s offices, pharmacies, and other healthcare facilities where patients routinely seek medical care, then share study details directly with patient medical teams. Engaging with enthusiastic providers enables selection of the most ideal mix of known, protocol-eligible patients.
Offer Site-Less and Hybrid Trial Access
Prioritizing healthcare-first patient access to clinical research removes the burden of travel for those who wish to participate in a clinical trial. Direct coordination with their existing care facilities simplifies the participation option, making enrollment easier than ever. Patients can sign up through their care provider, then participate from home or from a combination of at home and on-site at the provider’s facility. This simplifies participation for patients, leading to increased enrollment and retention.
Utilize EHR Data and AI-Powered Analytics
Find the right patients faster with unprecedented access to millions of known patients and their HIPAA-compliant identified healthcare data through AI-powered technology. EHR data and AI-powered analytics seamlessly determine the volume and location of patients needed for your protocol. You can search for known patients who are pre-vetted for protocol inclusion through HIPAA-compliant identified healthcare data then target, identify, and engage with specific patient groups, offering them clinical research as a care option at the optimal point in their healthcare journey through their trusted physician. This targeted approach streamlines the diversity action plan process and ensures patient centricity while identifying highly qualified patients with EHR data even before your study is greenlit.
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About Elligo Health Research®: Elligo Health Research accelerates clinical trials through EHR data, our proprietary IntElligo® technology, and direct access to known, diverse patients from more than 115 hospitals and major health systems, 200 healthcare-based sites, and 100 research-based sites. Our PatientSelect® model engages our network of networks to optimize the intersection of healthcare and research and bring more patients clinical research as a care option. Our SiteSelect model and Research Partner Services enable sites to seamlessly participate in trials, further advancing the development of new pharmaceutical, biotechnology, and medical device and diagnostic products.