In Medable’s first edition of Evidence and Insights, you’ll get an in-depth look at our research investments and collaborations in DCT and clinical research technology. Through strategic partnerships and continued investment, we’ve spearheaded efforts that redefine industry standards and set a new precedent for the evidentiary basis of technology’s impact on drug development.
Tufts CSDD analysis, co-lead by researchers at Tufts and Medable shows that -on average- decentralized clinical trials (DCTs) are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, respectively. The findings are based on financial modeling and analysis of trial data from the Tufts Center for the Study of Drug Development(CSDD) and contract data from more than 150 clinical trials enabled by Medable software. Tufts impact report about this study attached
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), Medable lead the creation of a taskforce that lead to a comprehensive toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review. The first-of-its-kind toolkit provides a common framework, tools, and best practices for uniform ethical review and approval and provides a roadmap for the ethical conduct of DCTs. Ultimately, such standardization will simplify, streamline, and speed the IRB/EC process – a key step towards more efficient, patient-centered research execution.
Duke University Department of Population Health Sciences’ Bioethics and Stakeholder (BASE) Lab and Medable researchers lead a pilot study (24 participants) on the comprehension and acceptability of enhanced electronic informed consent (eIC) versus text only eConsent in clinical trials. The pilot study compared participant comprehension and usability, satisfaction, and preference of enhanced eIC versus text-only eIC. While there was no difference in comprehension and acceptability , nearly three-fourths (71%) of the study participants said the enhanced eIC was more informative and indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research.
