Articles Tagged With:
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Risk of Neuropathy With Fluoroquinolones
As a class, fluoroquinolones are some of the most commonly used antibiotics worldwide. Their use carries a significant risk of neurotoxicty, for both the peripheral and central nervous system.
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Targeting Fyn Kinase in Alzheimer’s Disease: Another Failed Clinical Trial
In this multicenter Phase IIa clinical trial in mild Alzheimer’s disease dementia, the tyrosine kinase Fyn inhibitor AZD0540 had no significant effects after 52 weeks of treatment.
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Calcitonin Gene-Related Peptide Targeting Therapies for Migraine
Two randomized clinical trials showed that calcitonin gene-related peptide targeting therapies are effective and safe for primary headache disorders.
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Antisense Oligonucleotide Treatment of Huntington’s Disease: A Novel Potential Treatment
In this Phase I/IIa clinical trial, investigators administered antisense huntingtin oligonucleotides intrathecally to patients with early Huntington’s disease (HD), and demonstrated safety, tolerability, and dose-dependent reduction in CSF mutant huntingtin. This approach now is being tested for clinical efficacy in HD in a Phase III clinical trial.
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Indigenous People Grill NIH on All of Us Protections
Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians. A key part of the dialogue is letting American Indian/Alaska Native Tribal Nations ask questions and express concerns about the project.
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Identifiable Data Are Not What They Used to Be
IRBs and researchers should change their old habits when it comes to assessing studies for privacy and confidentiality. Researchers recently showed that de-identified data could be used to find a specific person. Using a mathematical model in databases of more than 200 populations, researchers found they could correctly re-identify 99.98% of Americans, using 15 demographic attributes.
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Tips for IRBs Reviewing Pragmatic Trials
Flexibility is needed when reviewing pragmatic clinical trials, which typically enroll a broader population of patients and might need more adaptable informed consent than traditional clinical trials. Researchers have raised questions about how pragmatic trials should be regulated and what IRBs should do to protect participants, but not discourage this type of research.
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Pragmatic Trials on the Rise as Data Collection Pushes Trend
Several recent changes are driving the pragmatic trial trend nationally, including acceptance from regulators and the growth of big data. Pragmatic clinical trials measure effectiveness of a study drug, device, or intervention on a wider range of people. Unlike clinical trials that exclude people based on health conditions and other criteria, pragmatic trials study a treatment’s effect on a group of people who are more representative of patients in clinical practice and the real world.
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Calls for IRB Transparency in a Closed-Door System
It is a common critical observation in human research that IRBs operate in a sort of “black box,” making decisions that could greatly affect a general public that remains largely oblivious of their role and function. This default ought to change toward transparency, both for the good of the research community and to be in line with the increasing calls for publishing research results, reporting all clinical trial data, and sharing consent forms, experts say.
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Update on National Certification for Individuals Who Perform Ethics Consults
The Healthcare Ethics Consultant-Certified program is a national standard that recognizes a consultant’s proficiency in identifying, counseling, and resolving ethical issues.