Large Simple Trials
We are looking into the possibility of expanding the DSRU’s work to include drug safety studies at GP surgeries, which would take the form of large simple trials (LST). LSTs are conducted under conditions intended to mimic the “real world” use of a drug as much as possible, with broad eligibility criteria. Several thousand people are enrolled on a trial, which runs for a number of years, with death or major illness serving as the trial endpoint. The phases of a typical LST are: invitation to participate, run-in phase (while previous medication is cleared from the body), randomised phase, end of trial. The trial would be co-ordinated by a study manager at DSRU and funded by the manufacturer, or other funding bodies.
The DSRU is uniquely placed to conduct such studies, due to its links with clinicians and the pharmaceutical industry, as well as its expertise in conducting epidemiological studies. Once we have established the infrastructure necessary to run LSTs, then this will be a valuable venture which will expand the research capabilities of the DSRU. We are in the process of building up a network of GPs and other contacts who are interested in taking part in such a trial. We are also considering candidate drugs and partners in the pharmaceutical industry for the first trial.