The Good Clinical Trials Collaborative published new draft guidance for Randomized Controlled Trials (RCT). This guidance was developed in partnership with over 100 experts from across the clinical trials community, but in order to ensure the guidance received maximum scrutiny, they opened the consultation to the public.
In our submission, after careful examination of the guidance, we supported the new guidance, but highlighted specific sections where we felt further explanation or clarification was needed. We also noted that guidance must go beyond assuming the development of a novel chemical entity as RCTs are also used for drug repurposing and for other modalities such as biologics, devices and cell and gene therapies.
Read our submission.
Read the updated guidance.