The National Institute for Health Research (NIHR) has launched a new Clinical Trials (CT) Toolkit web site designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements.
Based on the design of a tube map, the CT Toolkit uses an interactive color-coded route-map to differentiate between legal and good practice requirements. This provides essential information at the ‘stations’ along the route and gives the users an idea of the critical path for trial set-up and delivery.
“There is a vast amount of information on the internet relating to clinical trials that makes the process of navigating through the regulatory and governance minefield quite daunting. The CT Toolkit is designed to help this process,” said Tanya Symons, an independent Good Clinical Practice (GCP) expert who led on the content redevelopment of the new CT Toolkit. “This Toolkit is a one-stop shop for those who want information relating to the set-up and management of clinical trials.”
Although primarily aimed at those involved in publicly funded clinical trials of investigational medicinal products (CTIMPs), the CT Toolkit also benefits researchers and R&D staff working on trials in other areas, with information and guidance of relevance to the wider trials environment.
Professor Dame Sally C. Davies, chief medical officer and chief scientific adviser at the Department of Health, said, “Clinical trials are essential for testing treatments and ensuring we have the best possible evidence so that NHS patients receive high-quality care. It remains as important as ever to ensure trials are well designed and feasible: the CT Toolkit will help researchers to ensure that trial set-up and management processes are as efficient as possible.”
Visit the Clinical Trials Toolkit at www.ct-toolkit.ac.uk