ASCO Research Statement: Tapping the Potential of Observational Research


In a research statement reported in the Journal of Clinical Oncology by Visvanathan et al, ASCO has outlined steps for incorporating high-quality observational research into the evidence base for clinical decision-making.

As stated by the authors: “ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials. Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in [randomized controlled trials]. Observational studies can also answer or inform questions that either have not been or cannot be answered by [randomized controlled trials].”

The authors propose 5 general recommendations, and accompanying action items, aimed at ensuring high quality of data provided by observational studies and at facilitating uptake of such information into the evidence base for cancer care. They are summarized/reproduced here.

1. Improve the quality of electronic health data available for research

  • The Office of the National Coordinator for Health Information Technology (ONC) should continue to work with professional societies and other stakeholders to promote existing and emerging standards for the collection, exchange, and reporting of digital health-care information.
  • Electronic health record vendors should work with oncology providers, both in academic and nonacademic centers, to ensure their products support the capture of meaningful structured data (eg, stage, date of recurrence, patient-reported outcomes).
  • Professional societies should work with their members to identify key structured data elements, including patient-reported outcomes, for the delivery of high-quality cancer care that should be captured in all electronic health records.

2. Improve interoperability and the exchange of electronic health information

  • Professional organizations should monitor the implementation of the 21st Century Cures Act to ensure it achieves widespread interoperability in electronic health data and eliminates intentional information blocking.
  • ONC, the National Cancer Institute, and the Agency for Health Research and Quality should work with electronic health record vendors to promote and facilitate interoperability between different electronic clinical data and research systems.
  • Federal officials should work with professional organizations and other stakeholders to ensure that health-care providers have the information necessary to be prudent purchasers and users of health information technology systems.

3. Ensure the use of rigorous observational research methodologies

  • Researchers should follow best practices in observational research, as outlined in existing and developing methodology guides.
  • Professional organizations should participate in ongoing and future efforts to establish a uniform standard for the conduct of observational research.
  • Clinical training programs and professional societies should provide ongoing, formal training in the conduct and interpretation of observational research as well as emphasize the importance of collaborating with experts in observational research methodology.

4. Promote transparent reporting of observational research studies

  • Journals should encourage authors to follow reporting guidelines for observational research.
  • Journals should include experts in observational research methodology on editorial boards and among peer reviewers of manuscripts to ensure that published studies follow best practices in observational research, as outlined in existing and developing methodology guides.

5. Protect patient privacy

  • Professional organizations should join ASCO’s efforts to evaluate and update the existing regulatory structure, with the goals of identifying and closing gaps in existing privacy protections; ensuring the privacy and security rules facilitate the responsible reuse of data for research; and promoting ASCO’s principles of stewardship, protection, transparency, and accountability.

The authors conclude: “[C]ancer care and research are becoming more global and complex as clinicians incorporate new knowledge about the molecular characteristics of the disease, the addition of new and often targeted treatments, [and] greater reliance on shared decision making and patient input while also confronting rising costs. Observational research offers a previously untapped resource to navigate and inform these health care decisions. This research is likely to rapidly expand the evidence base that supports critical aspects of cancer care decision making and that complements the evidence collected in [randomized controlled trials]. The knowledge gained from observational studies will help the cancer care community reach its goal of providing high-quality, evidence-based care to all patients with cancer.”

Laura A. Levit, JD, of ASCO, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.