Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.
“A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients,” said FDA Commissioner Robert M. Califf, M.D. “These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results.”
GCPs are essential to help ensure the safety of trial participants, as well as the integrity of the data generated from trials. Over the years, the clinical trial enterprise has been viewed as costly, inefficient and constrained by inadequate collaboration and insufficient utilization of technology, data sources and innovations in design and conduct. The COVID-19 pandemic highlighted many of these challenges, while also spurring the development of new approaches.
“These draft recommendations were developed with the aim to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve,” said M. Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy. “We hope these recommendations, once finalized, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.”
ElZarrad led the ICH Expert Working Group in developing the ICH E6(R3) draft guideline. Academic clinical trial experts from various ICH member countries also played an important role in informing the work of the expert group.
This draft guidance, once finalized, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements. These elements have the potential to make trials more efficient and less burdensome. Additionally, the modernized GCP recommendations encourage the use of fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors could potentially facilitate more agile data collection and assist with patient recruitment.
The FDA recently issued other documents that complement these draft recommendations. The agency supports the adoption of innovative trial designs, when appropriate, and in May released draft guidance proposing recommendations for the implementation of decentralized clinical trials. Regarding DHTs, the agency also recently released a DHT framework document to guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
In addition to the recommendations supporting the modernization of trials, the principles outlined in the draft recommendations aim to make trials more efficient and potentially accelerate evidence generation for medical products by:
- Emphasizing the use of risk-based and proportionate approaches across the lifecycle of a clinical trial (e.g., data collection, monitoring, quality management). With this approach, investigators are encouraged to determine which data and clinical trial processes are most important to participant safety and data integrity, and focus efforts accordingly. This helps ensure investigators are allocating resources and efforts toward collecting and analyzing key data for the trial; and
- Encouraging sponsors to be proactive when it comes to a trial’s quality considerations. Quality considerations include attributes of a trial which are fundamental to the protection of participants, the reliability of trial results and the decisions made based on those trial results. Having an early focus on these factors helps ensure trials are designed efficiently, avoiding possible delays from unnecessary complexities and burdens.
As part of the FDA’s established process, this draft guidance will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH member countries before finalizing the ICH guideline.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
