Abstract 3595: Under-reporting of research biopsies in clinical trials in oncology

Abstract

Abstract Purpose: Research biopsies are frequently incorporated into 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. Methods: We identified a cohort of therapeutic clinical trials wherein at least one image-guided non-diagnostic research biopsy was performed between 1/2005 and 10/2010 from a large interventional radiology database at MD Anderson Cancer Center. Study protocols were compared with the highest level of corresponding publication as a manuscript, registry report, or abstract. Results: A total of 866 research biopsies were performed across 46 clinical trials (median 19 biopsies/trial). After a median follow-up time of 5.8yrs from study completion, 35 trials (76%) had published manuscripts (18 reported biopsy results), 8 (17%) had either a registry or abstract report (1 reported biopsy results), and 3 (7%) were not reported. In total, 19 trials (41%) reported biopsy results. Of these 19 trials, 6 (32%) trials under-reported the number of biopsies performed. Only 14 of 32 (42%) trials with mandatory research biopsies reported on these biopsies. Comments regarding biopsy quality/adequacy were reported in only 5 trials. Complications from these biopsies occurred in 39 pts (grade 3 in 6 pts) in 8 trials, but only 1 (13%) trial reported biopsy complications. Factors associated with better reporting of research biopsies are shown in the Table. When limited to only published manuscripts, results were unchanged. Academic sponsorship and a larger number of biopsies, especially serial biopsies, were associated with increased reporting of research biopsies. Conclusion: Despite ethical obligations to report research biopsies, 59% of trials do not report on these biopsies. Although complications occur, they are rarely reported. Clinical trial design efforts to ensure that an adequate number of research biopsies are obtained may lead to improved reporting of research biopsy biomarker results. VariableNTrials reporting biopsies (%)P-valueMandatory or optional biopsy1Mandatory (+/- optional)3314 (42)Optional135 (38)Total number of biopsies per trial0.002<10193 (16)10-302211 (50)>3055 (100)Trials with serial biopsies (No. of pts.)0.00011-5110 (0)>=51813 (72)Study sponsorship0.03Industry246 (25)Academic2213 (59)Clinical trial0.77Multicenter218 (38)Single center2511 (44)Phase of clinical trial0.51I or I/II3315 (45)II or III134 (31) Citation Format: Christine M. Parseghian, Kanwal Raghav, James Yao, Lee M. Ellis, Alda Tam, Michael J. Overman. Under-reporting of research biopsies in clinical trials in oncology [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3595. doi:10.1158/1538-7445.AM2017-3595