The term “clinical research” refers to studies, or trials, in which the device is tested in humans. Once a sponsor has sufficient pre-clinical data, the next step is to plan for clinical studies to establish the safety and effectiveness of the product. The Federal Food, Drug, and Cosmetic Act established a risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness and the level of regulatory control. Read about the Total Product Life Cycle here »
This whitepaper was authored by Margaret Sheehan and Anne Cohn Donnelly, who live with Parkinson’s disease and have participated as Patient Scientists on the MDIC PCOR project team along with representatives from the Michael J. Fox Foundation for Parkinson’s Research...
MDIC developed a novel method for incorporating patient-centered outcomes research (PCOR) into clinical trials designed with consideration of patient preference information. The goal is to expedite clinical trials and elevate the voices of smaller patient populations...
In May 2018, MDIC convened a public workshop to review and discuss the outcomes from MDIC’s Patient Centered Outcomes Research (PCOR) project. The workshop featured presentations and panel discussions involving experts from across the medical device ecosystem,...
This study design guide provides an outline of the qualitative steps for initiating a patient preference study. The guide only includes qualitative steps used to develop the preference survey and does not include the development of the preference study protocol or...
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...