Newsletter | July 21, 2020

07.21.20 -- Behind The ADAPTABLE Study, The Largest Decentralized Clinical Trial To Date

Behind The ADAPTABLE Study, The Largest Decentralized Clinical Trial To Date

The goal of the ADAPTABLE (aspirin dosing: a patient-centric trial assessing benefits and long-term effectiveness) study is to determine the dosage of aspirin that most effectively maximizes results while minimizing harmful side effects. A web-based application remotely manages the informed consent process, enrollment, and randomization of participants while allowing them to report their health outcomes throughout the study from the comfort of their homes.

State Of Patient-Centricity 2020: Advancing From Patient-First Intentions To True Co-Creation

This report explores how achieving patient centricity in clinical trials needs to evolve beyond patient engagement initiatives to patient co-creation and how these mutually beneficial partnerships will transform both the future of research and development and the healthcare industry at large.

Prioritizing Patient Safety While Pursuing High-Quality Data

While COVID-19 has frozen much of the world, healthcare marches on. The studies that will determine the safety and efficacy of health-improving and lifesaving drugs must continue. But now, attending scheduled site visits and collecting critical information from patients have become safety issues for patients and trial staff alike. Read more about how sponsor clients and the patients can mitigate risks for clinical trials amid COVID-19.

Digital Tools Powering More And Safer Clinical Trials

Even under COVID-19 quarantine, patients wearing remote sensors keep clinical research moving forward digitally. Bill Byrom, Signant Health, moderates this podcast with Paul and Jennifer Goldsack, Digital Medicine Society, and serves on the Steering Committee for the August 2020 virtual Digital Technology in Clinical Trials conference cosponsored by DIA and the ePRO Consortium of the Critical Path Institute.

The Growth Of Phase IV Trials And The Need To Demonstrate Effectiveness Using Electronic Patient Reported Outcomes

Pharmaceutical companies must now satisfy the value perceptions of multiple stakeholders, including payers, to attain market access for products. This article therefore seeks to address and describe the growing need to satisfy the value perception of multiple stakeholders and the importance of late phase trials capturing clinical outcome assessments (COA) and, specifically, electronic patient reported outcomes (ePRO) in relation to this.