Initiative slashes clinical trial approval times
6 August 2013
The JRO has been instrumental in the success of an initiative that has massively reduced time taken to approve clinical trials.
The Harmonisation project, initiated by UCLPartners, has reduced average approval time by around 90%, allowing more patients to access potentially life-saving therapies.
The aim of the project was to streamline the approval process for commercially sponsored trials, by having a single review, costing and contract undertaken by one 'permission centre' on behalf of all sites within UCLPartners.
Permission centres were based at UCLH, Barts Health, North Central London Research Consortium (NoCLoR), and Great Ormond Street Hospitals for Children with each centre responsible for approval of commercial studies within particular clinical areas. UCLH was responsible for cancer, ear nose & throat, genetics, immunisation & inflammation, infectious diseases & microbiology, metabolic & endocrine, nervous system disorders, neurology & dementia, ophthalmology , oral & dentistry, stroke and surgery.
Previously each individual hospital trust involved had to approve every part of any proposed commercial trial taking place on multiple sites, looking at issues such as legal compliance, safety, consent and risk assessment. This could result in protracted approval times when, for example, one trust did not have a radiation expert available to approve a safety aspect.
The project has reduced review time from an average of 104 days to 17 days and reduced time needed for local reviews of staff, equipment etc.
To put these figures into context, trusts within UCLPartners were previously low in national rankings for speed of approvals. However, current data shows that these trusts now have the fastest turnaround time in the country for approving new trials. In two recent examples UCL Partners trusts were the first to recruit in international studies.