12.21.20 Lilly, Care Access Take COVID Trial Directly To Patients
Introducing WCG IRB We’re combining best-in-class capabilities to raise the bar for our industry. Building on our 52-year legacy of expertise and service, our five industry-leading IRBs are now WCG IRB one unified team protecting human research participants and delivering a seamless review experience. Together at the forefront of research we are reshaping the future of ethical review with our unified experience and revolutionary new submission platform. Empowering research and advancing health.
Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
Eli Lilly and Company and Care Access Research have forged a unique partnership to develop and manage a first-of-its kind decentralized, mobile trial to safeguard the health of patients in nursing homes. Lilly and Care Access will take the trial directly to patients.
External Controls (Part II): Informed Choices Amidst A Portfolio Of Options
William L. Slone, Ph.D., Assistant Director, Clinical Research Methodology; Melissa Vadnais, VMD, Ph. D., Clinical Trial Methodology Fellow; Andrew Kuhlman, Medical Writer; Michael F. Murphy, MD, Ph. D., Chief Medical & Scientific Officer
As discussed in Part 1 of this series (EXTERNAL CONTROLS IN CLINICAL RESEARCH (PART I): THE CLINICAL IMPERATIVE), regulatory concepts referable to the creation of an external control group have long been noted and occasionally implemented, particularly for diseases with severe morbidity, mortality, and unmet medical need. As defined in Guidance for Industry: E10 Choice of Control Group and Related Issues in Clinical Trials (2001), “an externally controlled trial is one in which the control group consists of patients who are not part of the same randomized study as the group receiving the investigational agent.”