The University of California San Diego School of Medicine’s Center for Medicinal Cannabis Research is seeking participants for a set of clinical trials exploring the effectiveness of cannabidiol (CBD) and tetrahydrocannabinol (THC) in treating symptoms of severe autism, anorexia nervosa, essential tremor, and early psychosis. The studies are small, each recruiting fewer than 80 participants. (Candid Chronicle)
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)
Training is a hot topic at ACRP
Improving clinical monitor and coordinator training was a hot topic at the recent ACRP 2019 conference. The clinical trial professional of the future will need the skills to deal with increasingly complex protocols and ever-evolving technologies. According to one speaker, “In 18 months, half of what we know now will be irrelevant.” (CenterWatch)
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)
New FDA Guidance on adjusting for covariates in randomized trials
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)
Pipelines and Patients
— by John Neal The clinical research industry continued its rapid evolution during 2018, coming off of a year of major activity and changes in 2017. It is no time for the faint of heart, or those resistant to change. As I first predicted in 2016 in my “Change is Read more
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)
Use of surrogate end points shortens cancer trials
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)
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