FDA Releases Draft Guidance on Randomized Controlled Drug Trials in Routine Clinical Practice

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Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry. The guidance is intended to support the conduct of randomized controlled drug trials (RCTs) with streamlined protocols and procedures, with an emphasis on essential data collection and allowing integration of research into routine clinical practice.

FDA notes that advances in information technology and widespread use of electronic health records (EHRs) have facilitated access to real-world data obtained during routine clinical care and provided new opportunities for the integration of clinical research and clinical care.  Institutions may be able to enhance the integration of clinical research and clinical care by designing EHR systems that capture health care information in standardized formats, aligned with the format of information collected in case report forms used in RCTs.

Attempts to integrate clinical trials into routine clinical practice have been ongoing for many years and trials with simplified data collection have allowed for rapid enrollment and evidence generation.

The guidance notes that sponsors, health care institutions, clinical investigators, and local health care providers all have a role to play in RCTs that are integrated into clinical practice. For example, agreements between sponsors and health care institutions should document the responsibilities that are assumed by the institutions and their employees, as well as the tasks that they will perform in the clinical trial. Similarly, sponsors should obtain agreements from local health care providers to perform protocol-related tasks as appropriate, either directly or through the health care institutions in which they work. Clinical investigators are responsible for ensuring that a trial is conducted according to the signed investigator statement, the investigational plan, and applicable regulations (among other things). A clinical investigator can be affiliated with the institution or health care system where the RCT is conducted or they can be external.

FDA believes that trials that are most likely to be successfully integrated into clinical practice are those where the data needed for such trials are collected routinely in clinical practice visits with minimal need for protocol-specified procedures or additional visits.

This guidance applies to studies involving FDA-approved drugs being studied for new indications, populations, routes of administration, or doses; drug safety studies for FDA-approved drugs; other postmarketing studies for FDA-approved drugs; comparative effectiveness studies for FDA-approved drugs; ad trails of unapproved drugs when the safety profile is sufficiently characterized and the drug is appropriate to be administered and managed in the setting of routine clinical practice. It does not address observational studies. As is the case with FDA guidance documents, this document does not establish legally enforceable responsibilities but instead details the Agency’s current thinking on the topic.

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