Implications of Research Biopsies in Clinical Trials
- Increased interest in noninvasive testing for treatment monitoring, tumor burden estimation, and disease recurrence prediction.
- Lower-risk research specimens and liquid biopsies (blood, saliva, urine) offer alternatives to invasive biopsies.
- Liquid biopsies present new privacy and risk considerations, especially regarding DNA data extraction and usage.
- Precision medicine and research biopsies in clinical trials present ongoing challenges.
- Need for further studies to analyze clinical trials post-ASCO guidelines to evaluate dissemination and compliance.
- Funding agencies should carefully assess clinical trial protocols in light of ASCO recommendations.
Biospecimens are invaluable lynchpins in translational oncology, both to engender new discoveries and to assess the efficacy of new treatment paradigms. The collection and use of such specimens rely upon the patients and subjects who entrust clinicians with their bodies. This is especially true for research biopsies that are solely performed to enhance scientific understanding and may not offer any benefit to the individual patient or subject.
An ethical framework was recently developed by the American Society of Clinical Oncology (ASCO) to improve and inform the procurement of research biopsies in clinical trials. By considering their potential to increase scientific knowledge, the inherent risk of their collection, and whether they are required for clinical management, these guidelines assign weighted utility to biopsies [1]. Although the ASCO guidelines serve as an excellent model for researchers and clinicians alike, how they will be implemented in practice remains uncertain. It is thus critical to understand the guidelines, as well as to identify barriers to their use, especially as research biopsies become an increasingly common component of clinical trials...