概要
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Generating regulatory grade evidence in diverse patient populations in a priority focus in biopharma now that the bill has been passed December 2022. With the US legislation of the 21st Century Cures Act and 2022 DEPICT Act, designing clinical trials with increased access to care in a cost-effective method is a significant strategy for biopharma organizations. In this short course, we will include perspectives shared across collaborators from a decentralized clinical trial (DCT) vendor, real-world evidence (RWE) data, CRO, and biopharma that outline solutions to address the recent regulatory and policy guidance on diversity and digital engagements with patients.
- CHALLENGE - Importance of DCTs: inefficiencies compared to a decade ago
- Lack of Diversity and Inclusivity: According to the FDA Drug Trial Snapshots Summary Report for 2015-2019, 76% were white in a global racial participation
- Data quality and integrity: Data completeness, error rate, consistency, accuracy, and standards impact data quality and integrity. The industry touts a rate of more than 950 error per 10,000 fields in source-to-database caused by measurement error, recording error, transcription mistakes (source documents to CRF)
- Under-enrollment: Nearly 1/2 the sites under-enroll participants; 11% fail to enroll even a single patient
- Patient dropouts: The average patient dropout rate is 30% for a trial
- Limited/no patient feedback: Nearly 1/3 of the clinical trials do not gather feedback from the patient
- Lack of access/Physical limitations: More than 70% patients live more than 2 hours away from the nearest clinical trial site
- DESIGN - Digitizing Protocol Patient Engagement Trials: Many types of patients are underrepresented in research and cannot get to a physical trial site. Race, ethnicity, socioeconomics, lifestyle and environment differ across diverse patient groups and correlate with different therapeutic response levels.
- CO-LAB - Our Partnerships Evidence Lab will showcase Co-LAB-boration to bridge the digital divide meeting patients where they stand and connecting the real-world data that reflects a patient’s entire health profile. The course will provide approaches to outline the first step of patient diversity with an engaging Total Consent process to show a targeted engagement strategy to improve a diverse patient population with access to real-world data that reflects a patient’s entire health profile via tokenizations. Digitize the entire patient experience with mobile and remote participation technologies currently being utilized in industry, and RWE providers.
Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.