ASCO has published manuscripts that define the problem, make recommendations, and summarize the results of original analyses on many aspects of clinical trials and other types of research methodologies, including:
- Clinical Trials
- Adverse Events Reporting
- Broadening Eligibility Criteria in Cancer Clinical Trials
- Clinical Trial Reporting
- Ethical Issues in Clinical Trials
- Phase I Trials
- Geriatric Oncology
- Observational Research
- Other Topics
Adverse Events (AE) Reporting
ASCO Adverse Event Reporting Decision Aid: Results of an Interventional Study
This manuscript reports the findings of an interventional study that found that ASCO’s Adverse Event Reporting Decision Aid improved the accuracy of serious adverse event reporting by physician investigators and research staff. Click here to access the Adverse Event Reporting Decision Aid and Toolkit.
This ASCO Research Statement includes recommendations for streamlining serious adverse events reporting for cancer clinical trials.
Addressing Administrative and Regulatory Burden in Cancer Clinical Trials: Summary of a Stakeholder Survey and Workshop Hosted by the American Society of Clinical Oncology and the Association of American Cancer Institutes
The Best Practices in Cancer Clinical Trials Initiative was a priority for Dr. Julie Vose during her ASCO Presidency. The goal was to establish and promote practical solutions to common regulatory and administrative challenges to conducting and managing clinical research. Adverse events reporting was identified as a particularly burdensome activity by the initiative.
Broadening Eligibility Criteria in Cancer Clinical Trials
This ASCO-Friends of Cancer Research Joint Research Statement and four supporting manuscripts were published in a Special Series of the Journal of Clinical Oncology in November 2017.
This manuscript laid the groundwork for the ASCO-Friends of Cancer Research collaboration by establishing the rationale for updating existing cancer clinical trial inclusion/exclusion criteria in the age of molecularly-targeted agents.
Clinical Trial Reporting
ASCO and the Society for Immunotherapy of Cancer (SITC) released a joint statement with twelve clinical trial reporting recommendations that address the unique efficacy, toxicity, and combination/sequencing aspects of immune-oncology treatments.
Ethical Issues in Clinical Trials
An Ethical Framework for Including Research Biopsies in Oncology Clinical Trials: American Society of Clinical Oncology Research Statement
This manuscript presents ASCO’s ethical framework for the incorporation of optional and mandatory research biopsies in trials. It also discusses implementation of the ASCO framework, including the role of investigators, sponsors, regulators, institutional review boards, scientific review committees, and journals in improving the conduct of research biopsies.
Ethical, Scientific, and Regulatory Perspectives Regarding the Use of Placebos in Cancer Clinical Trials
TAPUR (Targeted Agent and Profiling Utilization Registry) Study
TAPUR publications are available on TAPUR.org
This manuscript summarizes the action items produced by the joint ASCO-U.S. Food and Drug Administration (FDA) Geriatric Oncology Workshop that was held on November 6, 2017.
ASCO Annual Meeting Education Session and Education Book Manuscript: Progress Through Collaboration: An ASCO and U.S. Food and Drug Administration Workshop to Improve the Evidence Base for Treating Older Adults With Cancer
This Education Session and corresponding manuscript summarized the outcomes of the ASCO-FDA co-sponsored workshop on geriatric oncology and outlined strategies for improving the evidence base for treating older adults with cancer.
This ASCO Research Statement discusses the expanding opportunities to utilize observational studies to advance cancer research and supplement the knowledge gained through cancer clinical trials. It makes five recommendations to enhance the role of observational research in clinical decision-making.
Other Research-Related Publications
When oncologic treatment options outpace the existing evidence: Contributing factors and a path forward: A Joint Statement by the American College of Surgeons Commission on Cancer, American Society for Radiation Oncology, American Society of Clinical Oncology, Society of Interventional Radiology, and Society of Surgical Oncology
Manuscripts published as part of the State of Cancer Care in America (SOCCA) series in the Journal of Oncology Practice are listed on the main SOCCA page.