11/26/2024
Photo by Olivier Collet on Unsplash
In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits (for more information see last week’s blog post on decentralized elements here). Randomized controlled trials (RCT) that have use information obtained in routine clinical care from local health care providers (HCP) are referred to as point of care or large simple trials. This practice is becoming more common with the increased use of information technologies and electronic health records. However, there are logistical considerations that need to be addressed in order to maintain the security and integrity of the obtained data.
The guidance breaks down the various roles and responsibilities within the trial for:
Sponsor: On top of their other trial related duties, sponsors should be the ones to reach out to the health care institutions or HCP networks and obtain agreements regarding what tasks they will be responsible for.
Principal investigators (PI): Like the rest of the trial conduct, it is up to the PI to ensure that all HCPs conducting trial-related activities are following their agreement made with the sponsor in order to uphold the rights, safety and welfare of the trial participants. The PI is also responsible for trial enrollment, specialized assessments, assessing adverse events, applying dose modifications and discontinuations, and determining the trial’s endpoint for each participant.
Local HCPs: HCPs involved in the trial do not need specific protocol training or research expertise, only the instructions needed to preform the trial related activity. They are also responsible for referring potential participants, collecting routine clinical data for the trial, documenting specified clinical events such as adverse events, and preforming routine medical procedures.
The remainder of the guidance goes over the critical-to-quality factors that are likely to have a meaningful impact on the participants right, safety, and welfare in order to implement a quality by design approach to trials using data from routine clinical care. These factors are:
Identifying the Trial Population
Obtaining Informed Consent
Choosing suitable Investigational Drugs
Randomization and Blinding
Comorbidities and Concomitant Medications
Study Endpoints
Adverse Events
Data Privacy and Security
Inspections
The entire guidance is provided here, anyone who wishes to comment on the draft can do so here until December 17th, 2024. To stay up to date on the FDA’s activity in regards to clinical trials such as draft and final guidance for industry, sign up for our blogs and newsletters today at https://www.clinicalpathwaysresearch.com/blog.
-The Clinical Pathways Team
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