'Better Representation' of Risks, Benefits of Research Biopsies Needed in Clinical Trial Protocols

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(ChemotherapyAdvisor) – “A better representation of the risks and benefits of research biopsies in study protocols and informed consents is needed.” That was the conclusion of a study published in the Journal of Clinical Oncology online November 5 that examined how study protocols and informed consents integrate and describe the use of research biopsies, for which limited information is currently available.

“Because a research biopsy represents an invasive procedure with finite risk and generally no direct benefit to the patient, ethical concerns over the use of research biopsies, especially mandatory biopsies, have been raised,” noted Michael J. Overman, MD, of The University of Texas MD Anderson Cancer Center, Houston, TX.

“...Some researchers have argued there is a ‘moral obligation to include correlative biopsies in appropriate clinical trials,' whereas others have argued the use of mandatory biopsies is appropriate when supported by a strong scientific rationale and adequate informed consent. Opinions are clearly divided, and at present, the Eastern Cooperative Oncology Group requires all research biopsies conducted on clinical trials to be optional.”

Dr. Overman and colleagues identified 57 therapeutic trials from an interventional radiology database in which image-guided research biopsies were performed from January 1, 2005 to October 2010; 38 (67%) required at least one mandatory biopsy. Data were extracted and analyzed from study protocols and informed consents and any procedural complications recorded.

Analysis of the research biopsy tumor tissue was a study end point in 95% of trials, they found. “The primary indication for a research biopsy was for integral biomarker analysis in 32% and for correlative science in 68% of trials.” Of the trials, statistical analysis that included the biopsy tumor tissue was mentioned in 26%, was described as exploratory in 51%, and not mentioned in 23%. “For studies with mandatory biopsies, biopsy was an eligibility criterion in 71% of trials, and a statistical justification for the research biopsy sample size was present in 50% of trials.”

Of the 576 patients included in the trial, 745 research biopsies were performed. “Overall and major complication rates for intrathoracic and abdominal/pelvic solid organ biopsies were 17.1% (36 of 211 biopsies) and 1.6% (three of 189 biopsies), respectively. Site-stratified research biopsy–related risks were discussed in five consents,” they noted.

An accompanying editorial noted, “the work by Overman et al helps us focus on the most relevant questions we should be debating regarding not if, but how best to pursue, meaningful science within a strong ethical foundation in oncology.”


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