RxE2 Releases Diversity Now, the First Protocol to Achieve Diversity in Clinical Trials According to the FDA Guidelines for Race and Ethnicity Diversity Plans
FARGO, N.D., Feb. 20, 2023 /PRNewswire/ -- The Diversity Now Protocol by RxE2 provides a pharmacist-centered approach for compliance with Section V, Categories 4 and 5 of the US Food and Drug Administration's industry guidance (FDA Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials – Guidance for Industry, April 2022).
RxE2 has the AI-enabled technology platform to comply with all necessary enrollment requirements as set by the FDA.
"Our goal is to ensure the appropriate proportion of pre-determined populations are proactively referred and enrolled to better achieve necessary protocol requirements and clinical and patient outcomes," says Gerald Finken, CEO of RxE2.
Based on the RxE2 model, pharmacists are engaged early to ensure that underrepresented populations are educated about clinical trials, and referred, recruited, and retained in clinical trials. RxE2 is already working with a network of approximately 3500 independent community pharmacies, accessing more than 18 million pharmacy records and 1.5 million unique and diverse patients.
Traditionally, informing patients about clinical trial opportunities has been the role of clinic staff and doctors. However, as decentralized trials become more prevalent and racial and ethnic diversity among participants increases, enrolling and retaining patients in clinical trials outside of the clinic setting requires more than providing study documentation; it is also necessary to have a trusting relationship. In many underrepresented communities, the community pharmacist is the most trusted and accessible healthcare provider. Local pharmacists are fundamental to diversifying clinical trials because, as medication experts, they already play a central role in community healthcare. They can provide the necessary information to encourage participation and understand patient needs and the social determinants of health (SDoHs) that often prevent enrollment.
"Involving pharmacists at the beginning of a clinical trial can offer a larger and more diverse pool of potential participants. Community pharmacists have strong local relationships and serve patients in the neighborhoods where they live, work, and want access to healthcare," said Tina Schlecht, Chief Pharmacy Officer of RxE2.
In partnership with the local pharmacy, RxE2 uses its AI-enabled technology platform to search pharmacy demographics and data to identify strategic locations and potential participants to contact about clinical trials. Pharmacies are also already engaging patients and addressing other factors that can prevent participants from enrolling and staying with clinical trials.
The Diversity Now Protocol by RxE2 addresses each of the points raised by the FDA and includes the first operational plan in the industry that sponsors can immediately employ with the help of RxE2. The protocol lays out a 6-step plan to ensure hitting enrollment goals from identifying the right patients through contact, referral and enrollment, monitoring, and pharmacist-supported counseling.
The protocol is available on the company website, and sponsors already benefit from the RxE2 approach.
RxE2 is a digital health company delivering a new community-based clinical trials concept powered by cutting-edge technology that provides patient recruitment, dispensing, counseling, and operational services to the pharmaceutical and biotech industries. We are entirely revolutionizing how clinical trials are conducted.
Tina Schlecht, Chief Pharmacy Officer of RxE2
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