The US Food and Drug Administration (FDA) released a draft guidance with updated recommendations for good clinical practices (GCPs).
The draft guidance is adopted from the International Council for Harmonisation's (ICH) recently updated E6(R3) draft guideline, which was announced in May. ICH’s guidance was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.
The FDA aims to modernise the design and conduct of clinical trials and make them more agile without compromising data integrity or patient protection. Industry stakeholders are welcome to submit their feedback until September 2023.
"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 Dr Robert Califf, adding that the draft recommendations propose a major step forward to ensure it.
Once finalised, the draft guidance will update the existing guidance, Good Clinical Practice: Integrated Addendum to ICH E6(R1), which was released in 2018. The revised version aims to cover a broad range of clinical trials, especially those with innovative design elements that have the potential to make trials more efficient and less burdensome.
In addition, the updated GCP recommendations will encourage the use of fit-for-purpose innovative digital health technologies (DHTs) such as wearable sensors that can facilitate agile data collection and assist patient recruitment.
FDA draft guidance agenda
The GCP draft guidance was one of the many documents included in the FDA’s Center for Drug Evaluation and Research (CDER) draft guidance agenda in 2023. While CDER outlines in the agenda that the centre is not “bound by this list of topics nor required to issue every guidance document on this list”, it gives an insight into what to expect from the agency.
The FDA plans to revise several of ICH’s guidance documents, as the agency aims to implement all ICH guidelines as FDA’s guidance. One planned draft guidance will be looking at adaptive clinical trials. The document is still being drafted by the ICH and the final version is expected in late 2024.
The agenda contains other notable new additions such as considerations for scientific investigations including psychedelic drugs. Experts told Clinical Trials Arena that the guidance may standardise the research, especially at a time when psychedelic research has been increasing.
In May, the FDA released a long-awaited draft guidance on decentralised clinical trials (DCTs). The document was teased late last year when US President Joe Biden signed the Fiscal Year 2023 omnibus spending bill into law.
