New ASCO Statement Lays Out Framework for Including Research Biopsies in Clinical Trials

July 30, 2019

ASCO has released an ethical framework for researchers on incorporating research biopsies in cancer clinical trials. The framework, published in a statement in the Journal of Clinical Oncology on July 25, provides guidance on when to include optional and mandatory biopsies based on both participant risk and scientific utility, as well as recommendations on necessary steps for improving the conduct of research biopsies overall.

Research biopsies differ from clinical biopsies in the fact that the latter are collected to inform patient care and the former are performed solely for scientific purposes. These types of biopsies allow researchers to potentially enhance the understanding of cancer and the effects of therapies, thereby improving diagnosis and treatment. However, they may offer no direct benefit to participants and have known risks depending on the invasiveness of the biopsy.

Because cancer clinical trials increasingly include research biopsies and many trial protocols make them mandatory for participation, critics have raised ethical concerns related to the adequacy of participant protections, informed consent, and patients’ understanding of the risks and benefits. In addition, current standards governing the use of research biopsies are limited, and the oversight responsibilities of the Food and Drug Administration, institutional review boards, and scientific review committees are not always robust.

To address these important clinical, research, and ethical questions, ASCO held a stakeholder meeting in May of 2018 with a diverse group of experts in oncology clinical trials, including those responsible for trial design and the administration, analysis, and oversight of research biopsies. Participants identified key ethical considerations surrounding research biopsies and then a multidisciplinary working group developed this ethical framework for incorporating research biopsies in trials.

The ethical framework builds on the available published literature and the 2018 stakeholder meeting to establish guidance for conducting both optional and mandatory research biopsies. It includes six recommendations related to three major goals for improving the ethics of research biopsies: 1) maximize scientific utility, 2) minimize participant risk, and 3) improve oversight. The recommendations are:

  1. Improve the scientific rationale for and conduct of research biopsies.
  2. Increase publication and dissemination of research biopsy safety and results.
  3. Promote best practices in the conduct of research biopsies.
  4. Improve serious adverse events reporting for research biopsies.
  5. Improve the informed consent process for trials requiring research biopsies.
  6. Ensure that proposed research biopsies are adequately reviewed during the study development process.

The authors of the framework also stress that the decision to consent to any specific biopsy included in a trial must be made at the level of the participant in conjunction with the investigator and may involve considerations beyond this framework. Minors and other populations with unique needs are also outside the scope of this framework, as children are protected in federal regulations and there are complex ethical factors that must be considered in that context.

ASCO’s Center for Research and Analytics (CENTRA) led the development of this framework. CENTRA’s mission is to conquer cancer by generating, integrating, analyzing, and sharing oncology data to foster innovation in research and patient care.

To read the full ethical framework, go to: https://ascopubs.org/doi/full/10.1200/JCO.19.01479.