Research Biopsies: An Integrative Review of the Experiences of Patients With Cancer

Abraham, Elizabeth J.; Post, Kathryn; Spring, Laura; Malvarosa, Giuliana; Tripp, Elizabeth; Peppercorn, Jeffrey; Bardia, Aditya; Habin, Karleen

doi:10.1188/18.cjon.e71-e77

Cited by 1 publication

(1 citation statement)

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“…It is also important to explore the motivations for patients to consent to research biopsies [22][23][24] . Patients appear to be overall willing to undergo research biopsies 25,26 with an acceptance of the associated risk. In a study aimed to assess the perceptions associated with mandatory biopsies 10 , it appears that 20% of patients would accept a 5 to 10% risk of a major complication whereas <1% of medical oncologists would accept the risk before approving such a study.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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Background. Biomarkers in clinical trials have led to massive incorporation of research biopsies, with potentially risks and no direct benefit for patients. In 2018, ASCO has released an ethical framework to provide guidance on incorporating research biopsies in cancer clinical trials. 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 ASCO framework and some trials characteristics. Results. Between January 2015 and December 2019, 178 oncological studies were conducted at IJB. 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 Ethical Framework was 67% for studies requiring tissue and went down to 39% for studies requiring at least one new biopsy.In multivariate analysis, the request for tissue or new biopsies was increased in early phase studies (p<0.001, p<0.001 respectively) and in studies investigating innovative treatments (immunotherapy or targeted therapies) (p<0.01, p=0.02). Compliance to ASCO framework significantly decreased with time (p<0.001) and in early phase studies (p<0.001). Conclusion.Numerous studies required tissue or new biopsies for exploratory objectives of unknown clinical utility. Request for tissue increases through years whereas compliance to ASCO's Framework decreases. The Oncologist 2021;9999:• • Implications for Practice: In 2019, the American Society for Clinical Oncology (ASCO) developed an Ethical Framework to provide guidance on incorporating research biopsies in clinical trials. We underline 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 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.

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