ASCO Releases Recommendations to Harness Untapped Potential of Observational Research to Inform Decision Making in Cancer Care

For immediate release
March 30, 2017


Mary Rappaport

ALEXANDRIA, Va. – The American Society of Clinical Oncology (ASCO) has released a set of recommendations to enhance the role of observational cancer research in clinical decision-making. Published in the Journal of Clinical Oncology (JCO), the ASCO research statement discusses the expanding opportunities to utilize observational studies to advance cancer research and supplement the knowledge gained through cancer clinical trials.

Unlike prospective clinical trials, in which patients are often randomly assigned to experimental or control groups and the results of the two are compared, observational cancer studies examine relationships among clinical characteristics–such as patient demographics, clinical features and lifestyle choices, treatments received, and outcomes. While prospective clinical trials remain the standard to establish new practice behaviors, observational research permits discovery of patterns in real-world cancer care, often including patients who were not eligible or did not wish to participate in a clinical trial.

Observational research has several strengths and can play a complementary role to prospective clinical trials, according to ASCO. Observational studies can also help generate hypotheses to test through randomized controlled trials (RCTs). Moreover, observational research can often better capture and reflect everyday clinical care. Only 3% to 5% of cancer patients participate in cancer clinical trials and those who are eligible to participate are often not representative of the larger population of cancer patients.

“Observational research can help us fill in existing knowledge gaps in cancer care,” said ASCO President Daniel F. Hayes, MD, FACP, FASCO. “By examining and analyzing real-world patient data, researchers can provide valuable insights that better reflect the cancer patients we see in everyday practice, who tend to be older and less healthy than clinical trial participants.”

The statement discusses several limitations to observational research. Observational studies, for example, are at a greater risk of bias than RCTs. Biases can occur in the selection of patients being compared, in differences in adherence to treatment, and in withdrawal from the study among certain participant groups, among others. Additionally, the reliability of observational studies is dependent on the quality and accuracy of available data that is drawn from databases that collect and aggregate real-life patient information. In order to effectively inform clinical practice, observational research must be high-quality, ASCO points out.

Recent developments in technology and public policy have paved the way for expanding the role of observational research in the cancer field, according to ASCO. There are growing databases of electronic health information, including emerging learning health systems, such as ASCO’s CancerLinQ®, which aggregate and analyze patient data to improve cancer care and support clinical decisions.

“With the proliferation of Electronic Health Records (EHR) and increasing utilization of big data in health care, there is unprecedented opportunity to conduct observational research to learn from real-world data in cancer research,” said Kala Visvanathan, MD, MHS, lead author of the ASCO research statement and professor of oncology and epidemiology at Johns Hopkins Sidney Kimmel Cancer Center and Johns Hopkins Bloomberg School of Public Health. “ASCO has identified specific steps that can be taken to address current issues with data quality and application, and ensure that observational studies are robust enough to effectively inform decisions in clinical practice.”


ASCO outlines five recommendations to enhance the role of observational research in clinical decision-making:

  1. Improve the quality of electronic health data. Widespread variability in EHR data and a lack of training requirements for those who enter data in electronic patient records make it difficult to aggregate and analyze data sets and ensure accuracy of EHR records. Establishing more standardized, structured data, and providing adequate training for EHR data entry is needed to enable high-quality observational research.
  2. Improve interoperability and the exchange of electronic health information. Most cancer patients receive care from multiple clinicians and specialists, so patient records are often siloed in different provider systems, resulting in incomplete or fragmented data. Combining data together from multiple sources is key to understanding a patient’s full experience and drawing meaningful, accurate research conclusions. To fully utilize big data and learning healthcare systems for observational research, improvements must be made in the ability to share electronic health information across systems.
  3. Ensure the use of rigorous observational research methodologies. Many organizations have developed methodology guides for observational research, however, a wide range of variability between guidelines exists. The development of a standard framework around best practices in observational research is needed to provide uniform guidance for conducting this kind of research. Improved training should also be encouraged to follow and implement standards and methodology guides.
  4. Promote transparent reporting of observational research studies. Currently, published observational studies are often missing important information about the study. Better reporting, including transparency about generalizability and bias, would make it easier to determine the applicability of an observational study in clinical decision-making and to reduce the potential for misinterpretation or misapplication of research findings.
  5. Protect patient privacy. Current privacy protections and regulations under the Health Insurance Portability and Accountability Act (HIPPA) have not kept pace with advances in research design and methodology, including the increased use of big data in research. Improvements should be made to the existing regulatory system to update current regulations that have been proven to impede research and inadequately protect patient privacy.

Read the full research statement in JCO. 



About ASCO: 

Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube. Visit for the latest cancer policy developments. For an overview of current policy issues, read ASCO’s cancer policy issue briefs.