2021 Update
Clinical Research Currents has temporarily suspended publication.
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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)
Do you have a question about research ethics and oversight? You can now turn to a new forum from WCG Clinical, “Ask the IRB Experts”, featuring WCG Clinical’s industry authorities. Questions may be submitted anonymously to the forum, and answers are posted on the WCG Clinical website. To ask a Read more
Novartis was recently inspected and cited with an Official Action Indicated (OAI) as part of their new drug application for their recently approved multiple sclerosis drug Mayzent (siponimod). In one study protocol, blinding was not adequately maintained, and study personnel were given inappropriate access to the database, raising questions as to whether inappropriate access to information led to bias. (Regulatory Focus)
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)
“Public vaccine policy treats the entire population as subjects of a mass uncontrolled experiment without their informed consent.” Vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDCP) have not been proven safe and effective. When the government uses coercion to gain compliance with vaccination policies, it constitutes an assault on the fundamental human right of informed consent. (Foreign Policy Journal)
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)
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)
A new proposal from the FDA would allow institutional review boards (IRBs) to amend or waive entirely informed consent where the intervention under investigation poses no more than minimal risk to participants. The FDA expects to withdraw related 2017 guidance, should the proposed rule become final. (Clinical Oncology News)
Photo: Peptide epitope of CD20 bound to Rituximab FAB. The American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC) have issued recommendations on Trial Reporting in Immuno-Oncology (TRIO). These recommendations are intended to improve the reporting of immune-oncology clinical trials and provide more evidence on the benefits and risks of this approach. Standardizing how trials are reported will also allow us to compare different immune-oncology trials. (cancernetwork)
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations. (outsourcing-pharma.com)