Under-reporting of Research Biopsies from Clinical Trials in Oncology

Purpose: Research biopsies are frequently incorporated within clinical trials in oncology, and are often a mandatory requirement for trial enrollment. However, limited information is available regarding the extent and completeness of research biopsy reporting.<br /><br />Experimental Design: We identified a cohort of therapeutic clinical trials where non-diagnostic research biopsies were performed between January, 2005-October, 2010 from an IR database at our institution. Clinical trial protocols were compared with the highest level of corresponding publication as a manuscript or registry report.<br /><br />Results: A total of 866 research biopsies were performed across 46 clinical trials, with a median of 8 patients biopsied/trial and 19 biopsies collected/trial. After a median follow-up time of 4.3 years from trial completion, 36/46 trials(78%) reported trial results: published manuscripts(n=35), or registry report(n=1). A total of 635 conducted biopsies were reported in 18/46 trials(39%). Six(33%) of these 18 trials under-reported the number of biopsies performed. Of 33 trials with mandatory research biopsies, 13(39%) trials reported on these biopsies. Biopsy complications occurred in 8 trials (n=39 patients, 6 Grade 3/4 AEs) but only 1 trial reported these. Factors associated with biopsy reporting included a larger number of biopsies(P<0.001), and serial biopsies(P<0.001). Twelve of 16 (75%) trials with >12 biopsies performed reported on these biopsies compared to only 20%(6/30) that performed ≤12 biopsies.<br /><br />Conclusions: Despite ethical obligations to report research biopsies, the majority (61%) of trials do not report results from research biopsies. Complications are rarely reported in these studies. Improved reporting of results and AEs from research biopsies is needed.

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