FDA Updates Recommendations To Modernize Clinical Trials

The US Food and Drug Administration has released a draft guidance on good clinical practices (GCPs) to improve the design and implementation of clinical trials. The goal is to make trials more flexible while maintaining data accuracy and participant safety. These updates aim to promote faster and more efficient clinical trials for the development of medical products. The guidance is based on the International Council for Harmonisation’s (ICH) updated E6(R3) draft guideline, which facilitates the integration of emerging technologies and methodologies into clinical trials.

FDA Commissioner Robert M. Califf, M.D., expressed that an enhanced clinical trial ecosystem, capable of generating reliable evidence in a more efficient manner, has the potential to facilitate well-informed decision-making in the development of medical products for the benefit of patients. He described the draft recommendations as a significant advancement in this endeavor, emphasizing the importance of integrating quality into trial design and implementation, as well as promoting the utilization of innovative trial designs and health technologies. These measures are crucial for the progress of clinical trials and the generation of impactful outcomes.

GCPs play a vital role in safeguarding the well-being of trial participants and maintaining the reliability of trial data. However, the clinical trial industry has long been criticized for its high costs, inefficiencies, and limited collaboration, as well as its underutilization of technology, data sources, and innovative practices. The COVID-19 pandemic further emphasized these issues while also stimulating the emergence of new methodologies.

The director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy, M. Khair ElZarrad, stated that the draft recommendations were created to enhance the efficiency and adaptability of clinical trials as the trial landscape evolves. The goal is to encourage careful and considerate approaches to conducting trials, prioritizing the safety of participants and the integrity of data. He led the ICH Expert Working Group in the development of the ICH E6(R3) draft guideline, with significant contributions from academic clinical trial experts from various ICH member countries.

The finalized draft guidance will update the existing guidance titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018).” The revised recommendations aim to be applicable to a wide range of clinical trials, including those with innovative design elements. These elements have the potential to increase trial efficiency and reduce burdens. Furthermore, the updated GCP recommendations promote the use of innovative digital health technologies (DHTs) that are tailored to specific purposes. DHTs, like wearable sensors, have the potential to facilitate agile data collection and aid in patient recruitment.

The FDA recently issued supplementary documents to complement the draft recommendations. These documents support the adoption of innovative trial designs, including decentralized clinical trials. Additionally, the FDA provided a framework for utilizing data from digital health technologies (DHTs) in regulatory decision-making for drugs and biological products. The draft recommendations aim to improve trial efficiency and accelerate evidence generation for medical products by –

• Highlighting the implementation of risk-based and proportionate strategies throughout the entire duration of a clinical trial. This involves determining crucial data and trial processes for participant safety and data integrity. This entails allocating resources, collecting, and analyzing key data. Sponsors should proactively address quality considerations to protect participants, ensure reliable results, and make informed decisions. Early focus on these factors streamlines trial design, avoiding unnecessary complexities.
• Encouraging sponsors to be proactive regarding quality considerations in a trial. The focus is placed on attributes that are vital for participant protection, the reliability of trial results, and the decision-making process based on those results. Aiming for an early emphasis on these factors ensures efficient trial design and minimizes potential delays caused by unnecessary complexities and burdens.

Following the FDA’s established procedure, the draft guidance will undergo a 60-day period for public comment. The ICH Expert Working Group will carefully review and take into account the comments received on the draft guidance, along with feedback from other ICH member countries. These inputs will be considered during the finalization of the ICH guideline.