Patients' selection and trial matching in early-phase oncology clinical trials

Crit Rev Oncol Hematol. 2024 Apr:196:104307. doi: 10.1016/j.critrevonc.2024.104307. Epub 2024 Feb 23.

Abstract

Background: Early-phase clinical trials (EPCT) represent an important part of innovations in medical oncology and a valuable therapeutic option for patients with metastatic cancers, particularly in the era of precision medicine. Nevertheless, adult patients' participation in oncology clinical trials is low, ranging from 2% to 8% worldwide, with unequal access, and up to 40% risk of early discontinuation in EPCT, mostly due to cancer-related complications.

Design: We review the tools and initiatives to increase patients' orientation and access to early phase cancer clinical trials, and to limit early discontinuation.

Results: New approaches to optimize the early-phase clinical trial referring process in oncology include automatic trial matching, tools to facilitate the estimation of patients' prognostic and/or to better predict patients' eligibility to clinical trials. Classical and innovative approaches should be associated to double patient recruitment, improve clinical trial enrollment experience and reduce early discontinuation rates.

Conclusions: Whereas EPCT are essential for patients to access the latest medical innovations in oncology, offering the appropriate trial when it is relevant for patients should increase by organizational and technological innovations. The oncologic community will need to closely monitor their performance, portability and simplicity for implementation in daily clinical practice.

Keywords: Developmental drugs; Early-phase trials; Personalized medicine; Precision oncology; Prognostic model.

Publication types

  • Review

MeSH terms

  • Adult
  • Clinical Trials as Topic
  • Humans
  • Medical Oncology
  • Neoplasms* / therapy
  • Neoplasms, Second Primary*
  • Patient Selection
  • Precision Medicine