2021 Update
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Authors of a new study published in JAMA Internal Medicine research found that just one-fifth of confirmatory trials for cancer drug indications approved via FDA’s accelerated approval pathway demonstrated improvements in overall survival (OS). Although improvement in surrogate measures may be acceptable for accelerated approval, confirmatory trials should verify the clinical benefits in terms of overall survival (OS) or quality of life. (Regulatory Focus)
Between 2009 and 2012, most newly approved therapeutics had at least 1 postapproval trial evaluating safety or efficacy. However, only 12% of the trials studied first FDA-approved indications, and more than 60% focused on unapproved or supplemental indications. Most were nonrandomized and uncontrolled, and more than one-third focused on a surrogate marker of efficacy rather than a clinical end point. (Cancer Therapy Advisor)
Before radiation, cancer patients usually get written consent forms to sign, which are intended to clearly spell out the treatment risks. A new study found that these forms are too complex for most patients to easily understand, suggesting that informed consent is not taking place. Although the National Cancer Institute recommends these documents be written at an eighth grade level, 92% were written above this level. (Reuters)
Bristol-Myers Squibb enters a multi-year strategic agreement with Concerto HealthAI to use machine learning to aid in protocol design for precision treatment and improved patient outcomes. (outsourcing-pharma.com)
blog.petrieflom.law.harvard.edu
The author argues that, in the FDA drug approval process, manufacturers have a strong motivation to promote the effectiveness of their drug, while downplaying the risks. This is called “the funding effect”- when scientists are hired by a firm with a financial interest in the outcome, then the likelihood that the results will be favorable to that firm is dramatically increased. (Bill of Health)
A study published in JAMA Oncology found that 1 in 6 cancer drugs approved between 2013 and 2018 were supported by randomized controlled trials (RCTs) that do not prove the drug’s superiority over the standard of care, as their control arms did not accurately represent the standard of care. “The choice of control arm should be optimized to ensure that new cancer agents are truly superior to what most clinicians would prescribe outside a clinical trial setting. (docwire)
Defining patient populations that will respond to a specific therapy is obviously important, and upon completion of trials a retrospective analysis is often performed to identify factors that may predict response. However, recent research finds that a new tool in biomarker discovery may be inferred through the analysis of Kaplan-Meier (KM) curves for time-to-event data from clinical trials. (Cancer Therapy Advisor)
The agency recommends that sponsors can use analysis of covariance (ANCOVA) to adjust for differences between treatment groups in relevant baseline variables, but should not use ANCOVA to adjust for variables that might be affected by treatment. (Regulatory Focus)
The use of surrogate end points (progression-free survival) (PFS) in oncology trials reduced the time needed to conduct clinical trials by 11 months compared to the study duration required to assess the overall survival (OS) benefit of a cancer drug. (MedicalResearch.com)
Run-in periods are occasionally used in randomized clinical trials to exclude patients after inclusion, but before randomization. During a run-in period, all patients receive the same treatment– for example, a placebo, the experimental drug, or observation only. A recent analysis of published trials found that 5% reported a run-in period, which could affect study validity if a large number of patients are excluded. (Dovepress)