Formal feasibility studies in palliative care: why they are important and how to conduct them.

The concept of clinical trial feasibility is of great interest to the community of palliative care researchers, clinicians, and granting agencies. Significant allocation of resources is required in the form of funding, time, intellect, and motivation to carry out clinical research, and understandably, clinical investigators, institutions, and granting agencies are disappointed when funded trials are unsuccessfully conducted. We argue that for many trials conducted in palliative care, the feasibility of conducting the proposed trial should be formally explored before implementation. There is substantial information available within the literature on the topic of study feasibility but no singular guide on how one can pragmatically apply this advice in the palliative care setting. We suggest that a Formal Feasibility Study for palliative care trials should be commonly conducted before development of a larger pivotal trial, to prospectively identify barriers to research, develop strategies to address these barriers, and predict whether the larger study is feasible. If a Formal Feasibility Study is not required, elements of feasibility can be specifically tested before launching clinical trials. The purpose of this article is to offer a draft framework for the design and conduct of a Formal Feasibility Study that, if implemented, could concretely support successful completion of high-quality research in a timely fashion. Additionally, we hope to foster dialogue within the palliative care research community regarding the relevance of establishing feasibility before initiation of definitive trials in the palliative care population.