Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Dec;26(12):1062-1070.
doi: 10.1002/onco.13906. Epub 2021 Aug 4.

Analyses of the Rationale and Implementation of Research Biopsies in Oncology Clinical Trials at a Tertiary Cancer Center

Nathalie Olympios #  1 , Laetitia Collet #  1 , Marianne Paesmans  2 , Christiane Jungels  1   3 , Nuria Kotecki  1   3 , Ahmad Awada  1 , Philippe Aftimos  1   3
Affiliations

Analyses of the Rationale and Implementation of Research Biopsies in Oncology Clinical Trials at a Tertiary Cancer Center

Nathalie Olympios et al. Oncologist. 2021 Dec.

Abstract

Background: Biomarkers in clinical trials have led to massive incorporation of research biopsies, with potentially risks and no direct benefit for patients. In 2018, the American Society of Clinical Oncology (ASCO) released an ethical framework to provide guidance on incorporating research biopsies in cancer clinical trials.

Materials and methods: We collected biopsy requirements of cancer clinical trials conducted at Institut Jules Bordet (IJB) between 2015 and 2019 to examine adherence with the ASCO Ethical Framework. We used logistic regression models to test the association between the request for biopsy, the request for tissue, and the adherence to the ASCO framework as well as some trial characteristics.

Results: Between January 2015 and December 2019, 178 oncological studies were conducted at IJB. Of these, 138 (78%) were sponsored by industry, 132 (74%) were phase II and III studies, and 141 (79%) concerned metastatic disease. Tissue was required for inclusion for 119 (67%) studies, among which 59 required at least one new biopsy. Adherence to ASCO's Ethical Framework was 67% for studies requiring tissue and went down to 39% for studies requiring at least one new biopsy. In multivariate analysis, requests for tissue or new biopsies increased in early-phase studies (p < .001, p < .001, respectively) and in studies investigating innovative treatments (immunotherapy or targeted therapies; p < .01, p = .02). Compliance to the ASCO framework significantly decreased with time (p < .001) and in early-phase studies (p < .001).

Conclusion: Numerous studies required tissue or new biopsies for exploratory objectives of unknown clinical utility. Requests for tissue increased over the years, whereas compliance to ASCO's Ethical Framework decreased.

Implications for practice: In 2019, the American Society of Clinical Oncology (ASCO) developed an ethical framework to provide guidance on incorporating research biopsies in clinical trials. This study underlines the growing request for tissue in clinical trials with potentially no impact on drug development and no benefit to actual or future patients. Adherence to ASCO's Ethical Framework decreases through time. These results highlight the importance of improving the ethics of research biopsies. ASCO's Ethical Framework offers an opportunity to improve quality of care in clinical research by maximizing scientific utility and allowing for clinically meaningful correlative science and safe access to innovative treatments for a maximum number of patients.

Keywords: Biopsy; Clinical trial; Medical oncology; Research ethics.

PubMed Disclaimer

Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1
Figure 1
CONSORT diagram of the study.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

References

    1. Sweis RF, Drazer MW, Ratain MJ. Analysis of impact of post‐treatment biopsies in phase I clinical trials. J Clin Oncol 2016;34:369–374. - PMC - PubMed
    1. U.S. Department of Health and Human Services, Food and Drug Administration Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff. 2018. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.... Accessed August 13, 2020.
    1. Freeman GA, Kimmelman J. Publication and reporting conduct for pharmacodynamic analyses of tumor tissue in early‐phase oncology trials. Clin Cancer Res 2012;18:6478–6484. - PubMed
    1. Goulart BHL, Clark JW, Pien HH et al. Trends in the use and role of biomarkers in phase I oncology trials. Clin Cancer Res 2007;13:6719–6726. - PubMed
    1. Beaver JA, Ison G, Pazdur R. Reevaluating eligibility criteria — Balancing patient protection and participation in oncology trials. N Engl J Med 2017;376:1504–1505. - PubMed