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
  • Geriatric Oncology
  • Observational Research
  • Other Topics  

Clinical Trials  

Adverse Events (AE) Reporting  

Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting from Investigators to Sponsors. 

  • 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.

Streamlining Adverse Events Reporting in Oncology  

  • 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  

Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement   

  • 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.  

Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research HIV Working Group  

Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research Brain Metastases Working Group  

Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group  

Modernizing Clinical Trial Eligibility Criteria – Recommendations of the ASCO-Friends of Cancer Research Minimum Age Working Group  

Modernizing Eligibility Criteria for Molecular Driven Trials  

  • 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  

Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement  

  • 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 

Geriatric Oncology  

Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop  

  • 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.  

Observational Research  

Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement  

  • 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   

Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement   

State of Cancer Care in America (SOCCA) Series

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.   

TAPUR (Targeted Agent and Profiling Utilization Registry) Study 

TAPUR publications are available on TAPUR.org