Review Finds Real-World Studies May Benefit CML Research
Posted: Wednesday, February 27, 2019
A review, published in Clinical Therapeutics, reported that real-world evidence and data, in addition to results from randomized, controlled trials, may benefit future research on chronic myeloid leukemia (CML). The report suggested that because of differences with clinical trials, real-world studies shed light on distinct aspects of treatment and patient outcomes. Jonathan Webster, MD, and B. Douglas Smith, MD, of Johns Hopkins University, Baltimore, noted that in combination with results from clinical trials, real-world evidence and data can “illustrate a more complete picture of the tolerability, effectiveness, and impact of a drug.”
“The recently published guidelines indicate that the [U.S. Food and Drug Administration (FDA)] expects a growing role for [real-world evidence],” the authors added.
Drs. Webster and Smith reviewed the new FDA guidelines on the use of real-world evidence. Using a PubMed literature search, they evaluated published data that used real-world studies of patients with CML. Data included sources such as patient registries, observational studies, and social media.
Real-world evidence has provided insight into the perspectives of patients with CML and informed early treatment milestones. Although real-world studies lack the controlled conditions of clinical trials, they noted, these methods have informed and continue to inform disease management. Together, randomized control trials and real-world studies may help clinicians more accurately forecast treatment challenges and optimize treatment paradigms.
Disclosure: The study authors’ disclosure information may be found at clinicaltherapeutics.com.