An investigation of current practice in the design and assessment of progression criteria in Canadian external pilot and feasibility studies

MRC : Katie Mellor : MR/N013468/1

Randomised controlled trials allocate people, at random (by chance), to receive an intervention e.g. a specific drug or treatment, to see how effective different interventions are. These types of studies provide the best evidence about the effectiveness (and harms) of health care interventions and ensure that health care decisions are made based on good quality evidence. However, randomised controlled trials can be very complicated and expensive to run. To ensure that research can be most effective and make the best use of our limited resources, sometimes researchers conduct smaller pilot and feasibility studies before they decide to run a randomised controlled trial. These pilot and feasibility studies help them to understand whether the future randomised trial can be successfully carried out, whether they should proceed with it, and if so how. It is not always clear how the decision is made based on this initial pilot or feasibility study as to whether the future randomised trial should be run. Often, different pilot and feasibility studies have varied definitions of what they expect to find out in order to decide that a future study should be undertaken. To investigate how researchers are currently making these decisions, I will review a sample of pilot and feasibility studies that have been approved in Canada, and I will talk to some researchers who are currently, or have recently, made these decisions to see what they think should be considered, and why they think it is important.