US FDA issues draft guidance on decentralised clinical trials 18 May 2023

 Decentralised clinical trials (DCTs) are being used increasingly in the pharma industry for clinical research and the US Food and Drug Administration (FDA) has published draft guidance for those carrying out trials at non-traditional investigation sites. 

 DCTs are being used more frequently since the COVID-19 pandemic and can help to overcome problems with diversity and inclusivity in research. 

 FDA Commissioner Robert M Califf, MD commented, “As we seek to improve our evidence generation system, decentralised clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”   

 Examples of decentralised elements covered in the guidance include obtaining laboratory tests at a local facility rather than a research medical centre or conducting a clinical follow-up visit in the trial participant’s home using telemedicine. 

 Comments on the guidance can be made until 1 August 2023.