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)
How is artificial intelligence (AI) impacting clinical trials?
There is much talk about clinical trial recruitment and using AI to mine electronic medical records (EHRs). Other applications include protocol design and optimization, and risk-based monitoring; site selection is primed for disruption with machine learning and AI. (Clinical Leader)
Analysis of survival curves helps identify biomarkers in clinical trials
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)
Site management companies help physicians with research burden
There are many obstacles for physicians outside of academia to conduct clinical research. These include managing research as a business, finding the next study, slow study startup, and locating and enrolling patients. Site management companies can help to reduce these barriers and allow investigators to concentrate on patient care and recruitment. (acrpnet)
Is it ethical to pay clinical trial participants different amounts?
Is it fair to pay different participants in the same study different amounts of money– in reimbursement for costs incurred; compensation for time and burden; and incentives to participate? The authors argue that differential payment is ethically acceptable, but it could potentially create tension among clinical trial participants. (Journal of Medical Ethics)
Can blood samples replace biopsies in matching cancer patients to trials?
Currently, enrollment to trials depends on a patient’s type of cancer, or genetic data obtained from an invasive tumour biopsy, which may not represent a patient’s current disease. According to research published in Nature Medicine, scientists could help match cancer patients with no other treatment options to clinical trials by analyzing the genetic faults in a sample of their blood. (Medical Xpress)
Bias in referral to Phase 1 cancer studies
This case-control registry study in Denmark found that novel anticancer therapies seemed to be tested on a socially selected group of patients with cancer. Patients with long distance to the Phase 1 unit, less education, and belonging to the lowest income quintile were less likely to be referred to Phase 1 trials. (PubMed)
Protocol amendments may be unnecessary
According to an expert, the rise in the number of protocol amendments occurring before the first patient has even received the first dose reflects a failure in planning trial design. Amending a protocol often involves making the study more complex, which impacts study costs and participant satisfaction. (CenterWatch)
Participants in failed Alzheimer’s trials react
Biogen and Eisai recently stopped two phase 3 trials of the Alzheimer’s treatment aducanumab after 36 months due to lack of efficacy. The 3,200 people in the trials and their families reacted with a sense of hopelessness and resign, particularly as there is no other treatment or clinical trial option for them. (STAT)
Recently Published Book: Clinical trials and the African person
This book explores ethical issues with clinical trials. When clinical trials, much of which are conceived in the Global North, involve other cultures, particularly Africa- in the Global South, where many of the trials are often offshored to, there is a need to apply some additional considerations, because the significance of the person in the African setting differs from the Western perspective. (blog of the APA)
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