biomarker clinical trial targeted therapy immunotherapy mandatory research biopsy oncology lung cancer head and neck cancer

Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials

by Jonathan H. Cheng, Justin W. Tiulim, Sheng Zhou, Anthony El-Khoueiry and Jorge Nieva

Oct 18^th 2019
10 mins
Frontiers in Oncology, Volume 9, Article 968

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Summary

The study investigates the impact of requiring fresh tumor tissue biopsies for enrollment in clinical trials. Key findings include:

Requiring biopsies significantly increases screening duration, with a median of 30 days compared to 14 days for trials without biopsy requirements (p < 0.0001).
These requirements do not lead to a statistically significant decrease in the number of days on trial or time until disease progression.
Informed consent forms for trials with mandatory biopsies did not reflect the delay in treatment caused by the biopsy requirement.

The analysis was conducted on patients enrolled in clinical trials at USC Norris Comprehensive Cancer Institute between January 16, 2013, and May 28, 2018, excluding those in the phase 1 program. Overall, the study highlights the need to consider the implications of biopsy requirements on trial durations and participant experience.

The number of biomarker directed clinical trials and cancer treatments is increasing (1). This trend is driven by a series of clinical experiences that demonstrate significant improvement in clinical outcomes and progression free survival in many cancers when biomarker directed therapy is employed (2, 3). Because of these positive results, trial sponsors have increasingly mandated clinical trial designs that require biomarker testing (4). In the United States, the annual spending on clinical trials that involve targeted therapies now exceeds spending on conventional chemotherapies; and there is a resultant increased interest in maximizing information from each trials by incorporating biomarker testing (5). While many study designs permit testing of archival tissue, fresh biopsies are Cheng et al. Mandatory Biopsy Delay Clinical Trials often required for reasons such as insufficient quantity/quality as well as possible concerns about heterogeneity and evolution of the marker over time. Prior single institution studies have reported that a biopsy requirement leads to a lengthening of the screening period, however this finding has not been confirmed elsewhere....

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