Challenges with end-of-life clinical pain trials

Authors

• JW Luk
• MF Thompson
• LA Novak
• BL Stangl
• ML Schwandt
• D Goldman
• VA Ramchandani
• N Diazgranados

Abstract

Clinical trial participation for refractory cancer pain in end-of-life patients presents numerous barriers that challenge study design and execution. By intent, patient recruitment involves participants that are medically unstable, with a multitude of complex issues, both physical and emotional. Patients with refractory pain often are taking opioid pain medications of various formulations, durations of action, and routes of administration that can complicate recruitment, pain measurement and produce an unacceptable set of side effects. Given this complex background and the high risk of disease-related serious adverse events, targeted development of analgesics in this patient population has been a neglected indication. The objective of this abstract is to examine the multiple considerations that can impede drug testing in this population spanning psychosocial issues to clinical trial design.
All studies involving patients at the end of life require a delicate balance of collecting data while minimally impacting their remaining life. In a phase I study, a patient may not receive benefit if treated early in a study (e.g. sub-therapeutic dose or placebo). Patient study visits and frequency as well as types of interventions need to be thoughtful and minimized. These studies are essential for improving the quality of life for this patient population but it is essential that all efforts are made to lessen interference with family interaction and end of life issues.

Scientific Focus Area: Clinical Research

This page was last updated on Monday, September 25, 2023