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随机对照试验随机(随机)分配受试者接受干预，例如特定的药物或治疗，以观察不同干预措施的效果。这些类型的研究为卫生保健干预措施的有效性(和危害)提供了最好的证据，并确保卫生保健决策是基于高质量的证据。然而，随机对照试验可能非常复杂，运行成本也很高。为了确保研究最有效并充分利用我们有限的资源，研究人员有时会在决定进行随机对照试验之前进行较小规模的试点和可行性研究。这些试点和可行性研究有助于他们了解未来的随机试验是否可以成功进行，他们是否应该继续进行，如果应该的话，如何进行。对于未来的随机试验是否应该进行，人们并不总是清楚如何根据最初的试点或可行性研究做出决定。通常，不同的试点研究和可行性研究对它们期望发现的东西有不同的定义，以便决定是否应该进行未来的研究。为了调查研究人员目前是如何做出这些决定的，我将审查加拿大已经批准的试点和可行性研究的样本，我将与一些正在或最近做出这些决定的研究人员交谈，看看他们认为应该考虑什么，以及为什么他们认为这很重要。

MRC : Katie Mellor : MR/N013468/1Randomised 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.