Consumer Contribution in Designing Medicinal Cannabis Clinical Trials in Palliative Medicine.

Abstract

<b><i>Background:</i></b> Medicinal cannabis clinical trials in palliative medicine present unique and complex challenges encompassing ethical, legal, and feasibility obligations, making consumer input essential. However, little is known about the consumer contribution in the medicinal cannabis research space. <b><i>Objective:</i></b> We present a case report on consumer contribution in the design and conduct of a Phase I/IIb medicinal cannabis clinical trial for anorexia in people with advanced cancer. Our discussion highlights the various ways consumers contribute through (1) lived experience, (2) knowledge, (3) inclusion as investigators, (4) advocacy, and (5) outreach, considering approaches that can mitigate bias. <b><i>Conclusion:</i></b> Consumer contribution shaped the study design, ensured successful implementation and completion of the trial, and will guide future dissemination of the results. It is crucial that consumers are included at all stages of the research process to uphold research integrity and alignment with future clinical practice and policy. <b><i>Clinical Trial Registration:</i></b> ACTRN12616000516482.