Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?
Because of differences in how they were tested in clinical trials, it is difficult to make apples-to-apples comparisons for COVID-19 vaccines.
Human Subjects Research
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Read more: Incidental Findings in Deep Phenotyping Research: Legal and Ethical Considerations Incidental Findings in Deep Phenotyping Research: Legal and Ethical Considerations
What obligations do researchers have to disclose potentially life-altering incidental findings as they happen in real time?
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Read more: Unique Challenges to Informed Consent in Deep Phenotyping Research Unique Challenges to Informed Consent in Deep Phenotyping Research
Obtaining voluntary competent informed consent is a critical aspect to conducting ethical deep phenotyping research.
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Read more: “Actionability” and the Ethics of Communicating Results to Study Participants “Actionability” and the Ethics of Communicating Results to Study Participants
What data may be considered “actionable” for the physician to disclose to the patient, and how might this be done?
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Read more: Racial Disparities Persist in Human Subjects Research Racial Disparities Persist in Human Subjects Research
Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.
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Read more: Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II) Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)
Almost immediately, there was a public outcry about the possibility that this was an illegal or unethical “research experiment.”
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Read more: Human Subjects Research in Emergencies: An Ethical and Legal Guide (Part I) Human Subjects Research in Emergencies: An Ethical and Legal Guide (Part I)
Without minimizing the need for haste, it is important to remain aware of the risks inherent in rushing to treat patients with anything that might work.
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Read more: Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy
By Mason Marks FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug…
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Read more: The Precision Medicine Initiative and Access The Precision Medicine Initiative and Access
By Leslie Francis Persistent differences in participation in clinical trials by race and ethnicity are well known; for example, the 2015 Report of the Working Group on Precision Medicine (PMI) relies on statistics that only 5% of clinical trial participants are African-American and only 1% are Hispanic. A recently-launched website of the FDA, “Drug Trials…
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Read more: NPRM Symposium: Escape for Many, Scant Relief for Those Left Behind NPRM Symposium: Escape for Many, Scant Relief for Those Left Behind
By Zachary Schrag [Cross-posted from Institutional Review Blog] While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance…