ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010
Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.
- Recommendations for cellular and molecular pathology input into clinical trials: a systematic review and meta-aggregation.The journal of pathology. Clinical research · 2021Pooled it
- Feasibility, safety, and adequacy of research biopsies for cancer clinical trials at an academic medical center.PloS one · 2019Trial
- The use of pharmacodynamic results for recommended phase II decision making in oncology clinical trials.Cancer chemotherapy and pharmacology · 2026Review
- Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?Ethics & human research · 2022Article
- Article
- Gut microbiota and human NAFLD: disentangling microbial signatures from metabolic disorders.Nature reviews. Gastroenterology & hepatology · 2020Review
- Diagnostic Accuracy and Safety of Coaxial System in Oncology Patients Treated in a Specialist Cancer Center With Prospective Validation Within Clinical Trial Data.Frontiers in oncology · 2020Article
- Patient advocate involvement in the design and conduct of breast cancer clinical trials requiring the collection of multiple biopsies.Research involvement and engagement · 2018Article
- Underreporting of Research Biopsies from Clinical Trials in Oncology.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Burdensome Research Procedures in Trials: Why Less Is More.Journal of the National Cancer Institute · 2017Article
- Participant Attitudes Toward an Intensive Trial of Multiple Biopsies, Multidimensional Molecular Analysis, and Reporting of Results in Metastatic Triple-Negative Breast Cancer.JCO precision oncology · 2017Article
- Pediatric Oncology Provider Views on Performing a Biopsy of Solid Tumors in Children with Relapsed or Refractory Disease for the Purpose of Genomic Profiling.Annals of surgical oncology · 2016Article
- Precision Oncology: Identifying Predictive Biomarkers for the Treatment of Metastatic Renal Cell Carcinoma.Translational cancer research · 2016Article
- Article
- Participation in Cancer Pharmacogenomic Studies: A Study of 8456 Patients Registered to Clinical Trials in the Cancer and Leukemia Group B (Alliance).Journal of the National Cancer Institute · 2015Observational
- Variation in the Attitudes of Medical Oncologists Toward Research Biopsies in Patients With Metastatic Breast Cancer.The oncologist · 2015Article
- Article
- Prospective clinical experience with research biopsies in breast cancer patients.Breast cancer research and treatment · 2013Article
- Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials.British journal of cancer · 2013Article
- Biopsies: next-generation biospecimens for tailoring therapy.Nature reviews. Clinical oncology · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical investigators in oncology are increasingly interested in using molecular analysis of cancer tissue to understand the biologic bases of response or resistance to novel interventions and to develop prognostic and predictive biomarkers that will guide clinical decision making. Some scientific questions of this nature can only be addressed, or may best be addressed, through the conduct of a clinical trial in which research biopsies are obtained from all participants. However, trial designs with mandatory research biopsies have raised ethical concerns related to the risk of harm to participants, the adequacy of voluntary informed consent, and the potential for misunderstanding among research participants when access to an experimental intervention is linked to the requirement to undergo a research biopsy. In consideration of the ethical and scientific issues at stake in this debate, the Cancer and Leukemia Group B Ethics Committee proposes guidelines for clinical trials involving mandatory research biopsies. Any cancer clinical trial that requires research biopsies of participants must be well designed to address the scientific question, obtain the biopsy in a way that minimizes risk, and ensure that research participants are fully informed of the risks, rationale, and requirements of the study, as well as of treatment alternatives. Further guidelines and discussions of this issue are specified in this position paper. We feel that if these principles are respected, an informed adult with cancer can both understand and voluntarily consent to participation in a clinical trial involving mandatory research biopsy for scientific end points.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.