Patients' understanding of oncology clinical endpoints: A literature review

Patient Educ Couns. 2020 Sep;103(9):1724-1735. doi: 10.1016/j.pec.2020.03.018. Epub 2020 Mar 20.


Objectives: Oncology clinical trials use a variety of clinical endpoints. Patients' understanding of the differences between clinical endpoints is important because misperceptions of treatment efficacy may affect treatment decisions. The objective of this literature review is to find and synthesize available empirical publications assessing patients' understanding of common oncology clinical endpoints.

Methods: We conducted a literature search of 5 databases and 3 conferences, limiting the search to articles and abstracts published in English through September 2018. We reviewed the titles and abstracts for inclusion, then reviewed full texts to determine if they reported empirical research studies focused on (1) clinical endpoints, (2) oncology, and (3) patient understanding. The original search identified 497publications, of which 13 met the inclusion criteria.

Results: Available literature yields little information on this topic.The few publications that do exist suggest that healthcare professionals and cancer patients generally do not discuss clinical endpoint concepts and that patients can be confused about the purpose of a treatment based on misperceptions about endpoints.

Conclusions: Research is needed on how to discuss oncology clinical endpoints with patients.

Practice implications: Patient-friendly definitions of clinical endpoints may help healthcare providers communicate important information about treatments to patients.

Keywords: Clinical endpoints; Patient understanding; Patients; Progression-free survival; Regulatory science.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Clinical Trials as Topic / methods*
  • Comprehension
  • Disease-Free Survival
  • Endpoint Determination*
  • Humans
  • Medical Oncology*
  • Neoplasms / therapy*
  • Patient Education as Topic
  • Patients / psychology*