More than half of unapproved applications for clinical trials require more information, the MHRA said in new guidance to industry.
The most common mistakes included not providing an XML file of the completed application, not listing a point of contact at the company, and failing to provide proof of payment.
Sponsors must also include all potential risks to trial participants, and propose strategies to mitigate them. Procedures for unblinding in case of an emergency are required, as well.
In study design, endpoints or treatment durations based on when the drug will be commercially available or approved for marketing will not be accepted. Dose stopping criteria must also be clearly defined.