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Physician, Regulatory, and Payer Perspectives on the Value of Real-World Data

Surabhi Dangi-Garimella, PhD
One of the kickoff sessions on the first day of the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, was a lively discussion on ensuring that the data used to inform patient care and create healthcare policies holds value.
One of the kickoff sessions on the first day of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, was a lively discussion on ensuring that the data used to inform patient care and create healthcare policies holds value. This, according to the speakers who participated on the panel, entails moving away from clinical trial data and foraging real-world data captured in health records

The goal of the session was to identify existing and developing data sources that can be used to inform comparative effectiveness research, patient care, and healthcare policy. The presenters also provided examples of questions that can be asked using these data, and described how payers consider observational data alone or in conjunction with data from clinical trial.

Ronald C. Chen, MD, MPH, associate professor, Department of Radiation Oncology, The University of North Carolina at Chapel Hill, was both presenter and chair of the session, and he tried to convince listeners that while randomized controlled trials (RCTs) are the industry’s gold standard, they come with significant limitations.

Chen explained that RCTs are not obsolete and that they are a significant source of information, "but there are gaps that exist and we need to find alternatives.” Comparative effectiveness research is unbiased comparison that yields valid results. “The goal is to estimate the truth … which RCTs help with, especially when it comes to comparing the efficacy of product A vs product B,” Chen said. He added that RCTs and observational data together can prove helpful to clinicians, policy makers, payers, and patients.

While RCTs minimize confounding, there are limitations to this gold standard, Chen added. He then cited the Prostate Cancer Intervention Versus Observation Trial (PIVOT) as a case study. The primary question that PIVOT asked was whether radical prostatectomy can save lives in men who have localized prostate cancer. Starting with a large cohort of over 13,000 men, only 5000 met the trial’s eligibility criteria. Of these, only a little over 700 patients were randomized between the 2 arms: radical prostatectomy and observation, between 1994 and 2002; the follow-up period ended in early 2010 and the results were published in 2012.

The trial found no difference in survival between the observation and the surgical intervention arms, but nearly 20 years after it was initiated.

Chen listed the following potential limitations of RCTs:
  • Patients are often highly selected (younger, healthier)
    • This begs the question: are outcomes representative of “all” patients in the real world? Generalizability is a concern. “Can decreased generalizability decrease treatment adoption?” he asked.
  • Can results remain relevant, especially since RCTs usually require a long time to completion?
  • Is it possible for RCTs to provide clinically relevant and timely results?
  • Not every clinically important question can be addressed through an RCT


 
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