Verifying Rigid Clinical Trial Evidence
It has long been accepted that randomised clinical trials whilst providing robust internal validity have limitations when considering their applicability to the wider population. The founder of the Cochrane Collaboration, Dr Archie Cochrane stated the same when considering effectiveness and efficacy in 1972. More recently, Sir Michael Rawlins the Chairman of NICE has also stated his concerns regarding use of evidence and the generalisability of results from randomised controlled trials to the wider population. Clinical trials frequently exclude people with certain conditions, taking certain medications or just don’t fit the age, sex or risk factor profiles required at baseline. They therefore study a finite population usually for a short limited period of time. In order to provide more robust evidence of a treatments benefits and safety in a wider population, further data needs to be gathered from actual use in these people, often over longer time periods – real data from real patients. The Patients Direct methodology allows you to gather this information in a controlled systematic manner allowing analysis of outcomes of interest and validation of your clinical trial results.
