MHRA Details Common Issues in Clinical Trial Applications
Posted 23 March 2017 | By
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays.
According to the agency, more than half of the approximately 1,000 clinical trial applications submitted each year require additional information before they can be reviewed and approved.
While MHRA typically reviews clinical trial applications for Phase I studies in around 12 days, and 22 days for other trials, the agency says that review times can double or triple when it needs to get more information from a sponsor.
"When [grounds for non-acceptance] GNA points are raised, it can add up to 21 days to the final approval time for a Phase I application and 23 days for other phases, depending on the time taken for the applicant to submit their response and MHRA assessment of that response," the agency says.
MHRA says that even with these delays, it is usually able to hold to the 60-day statutory limit for reviewing clinical trial applications, but acknowledges that the delays have negative impacts on both sponsors and patients.
The guidance itself is broken up into five separate documents detailing the top issues related to application validation: non-clinical and clinical data, information about the product itself and a list of resources with links to relevant guidance and standards for each of the aforementioned areas.
For instance, MHRA says that 15% of the clinical trial applications it receives are turned back at the validation stage due to missing or incomplete data, and that the most common clinical issues involve inadequate information about risk mitigation strategies.
However, MHRA notes that the guidance should not be viewed as an exhaustive checklist, and says that some of the issues listed may not be relevant to all clinical trials.
"Sponsors who do not comply with some of the issues raised in this guidance might not necessarily receive a GNA if they have provided an acceptable scientific (safety) justification for not complying with guidance," MRHA says.