Optimizing care in early phase cancer trials: The role of palliative care

•Patients who enroll on early phase clinical trials (EPCTs) usually have advanced cancer and heightened symptomatology, yet maintain a robust performance status that qualifies them for clinical trial participation.•These patients require a tailored palliative care approach that acknowledges the time toxicity experienced by patients enrolled in EPCTs and addresses the challenges posed by shortages within the palliative care workforce.•We suggest that every patient with advanced cancer referred to EPCT be referred to palliative care to be seen concurrently while undergoing screening for trials, with follow up during trial determined by clinical need. We also recommend every patient re-engage with palliative care at end of trial if no longer attending palliative care clinic.•A multi-disciplinary palliative care intervention with an embedded palliative care practitioner within EPCT clinics would be the optimal intervention for this population of patients. Advancements in cancer treatment have led to improved survival rates, with early phase clinical trials (EPCTs) serving as important initial steps in evaluating novel therapies. Recent studies have shown that response rates in these trials have doubled in the last twenty years. Patients who enroll on EPCTs have advanced cancer and heightened symptomatology yet maintain a robust performance status that qualifies them for clinical trial participation. It is well established that many of these patients have needs that can be addressed by palliative care, including symptom management, value assessments, advance care planning, and psychosocial and spiritual support. Several small studies have aimed to identify the most beneficial palliative care intervention for this cohort of patients, ranging from formal clinic-based multidisciplinary palliative care interventions to home-based interventions. While outcomes have trended towards benefit for patients, especially pertaining to psychological well-being, most studies were not powered to detect additional benefits for improved physical symptom management, reduction in care utilization or increased length of time on trial. In this review, we discuss the unique palliative care needs of this population and what we can learn from results of past interventional studies. We advocate for a tailored palliative care approach that acknowledges the time toxicity experienced by patients enrolled in EPCTs and address challenges posed by shortages within the palliative care workforc