FDA Framework for Use of Real-World Evidence



The U.S. Food and Drug Administration (FDA) released a Framework in December 2018 for the use of real-world evidence, which is not routinely collected during the course of a clinical trial. Under the 21st Century Cures Act, the FDA was to establish a program to evaluate the use of real-world evidence to help support a new indication for an approved drug or to satisfy post approval requirements. RWE evidence has been used by the FDA for some time to monitor drug safety, but its use to determine effectiveness has been limited.

CTTI Releases Recommendations for Real-World Data in Study Planning and Recruitment



Clinical Trials Transformation Initiative (CTTI) released recommendations and tools related to using real-world data (RWD) to inform selecting eligibility criteria and recruitment of subjects for clinical trials. RWD are data related to patient health and health care delivery. Data are commonly collected from Electronic Heath Records (EHR) or other sources related to patient health, such as insurance claims. RWD has been available, but there has been a lack of research or consensus on how to use the information beneficially for clinical trials. These recommendations were developed through research and collaboration with stakeholders, including patients and caregivers, to provide the first steps for how sponsors may best use the RWD to plan for clinical trial eligibility requirements and recruitment.

FDA Releases Draft Guidance on Device Clinical Trials and Patient Engagement: Comment Now!



The US Food and Drug Administration (FDA) released a draft guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The purpose is to guide industry in accounting for patient and caregiver perspectives on living with a particular disease or condition and how medical devices impact their lives. The draft guidance is part of the FDA Patient Engagement Advisory Committee (PEAC) initiative to increase patient engagement in medical device clinical trials. The idea is that patients must be willing and able to use a medical device in order for it to have a practical benefit, so understanding any potential barriers prior to conducting a clinical trial would be beneficial.