Hot Topics: Clinical Trials & Studies
by Kiarash Aramesh M.D., Ph.D.
The COVID-19 pandemic has been accompanied by a surge of pseudoscientific claims, sometimes made or supported by political powers.…Full Article
by Jamie Webb MA, MSci
‘An experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers, its maker announced Monday.’…Full Article
by Jing Wan,Yuqiong Huang, Amaneh Abdel Hafez Aljaafreh, Dandan Dong, Yali Cong , Jun Lin, Hongxiang Chen
COVID-19 is an emerging infectious disease that is extremely contagious and can cause serious consequences and even death.
by Keisha Ray, Ph.D.
I take the drug hydroxychloroquine, brand name Plaquenil, for an autoimmune disease. Hydroxychloroquine was once used to treat malaria and is now commonly used to treat a range of inflammatory disorders like lupus and rheumatoid arthritis.…Full Article
by Craig Klugman, Ph.D.
In a news item reported in Rolling Stone, NPR, and The Houston Chronicle, the medical director of a coastal Texas nursing home used his political connections to get enough hydroxychloroquine to begin his own “observational” trials—minus a control group, minus informed consent, minus informing anyone.…Full Article
by Ariadne A. Nichol, B.A.
Development of experimental vaccines to combat the COVID-19 pandemic has been rapidly progressing. In the United States, several Phase I clinical trial participants already received an injection of mRNA-1273, the experimental vaccine developed by the National Institutes of Health (NIH) and a biotechnology firm called Moderna.…Full Article
by Craig Klugman, Ph.D.
On March 31, the U.S. Department of Justice put in an order for $60,000 worth of hydroxychloroquine, a drug that Trump has been pushing as a treatment for COVID-19 (to clarify, it is unproven and has never worked on any other coronavirus).…Full Article
by Farid Rahimi, Ph.D. ELS and Amin Talebi Bezmin Abadi, Ph.D.
The first reports of “pneumonia of unknown cause” emerged from the Wuhan City, China, three months ago.…Full Article
by Thibaud Haaser, MD, PhD
The current coronavirus pandemic challenges health care systems, raises ethical questions about health policies, and makes some countries fear or even face dilemmas over the allocation of scarce resources.…Full Article
by Craig Klugman, Ph.D.
Dale is a 45-year-old woman who lives in Southern California. She has been a patient of Kaiser- Permanente to treat her chronic illness, systemic lupus erythematosus (SLE).…Full Article
Partnering With Patients to Bridge Gaps in Consent for Acute Care Research
Patient’s Perspectives of Experimental HCV-Positive to HCV-Negative Renal Transplantation: Report from a Single Site
Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error
Ethics and Collateral Findings in Pragmatic Clinical Trials
Media Coverage of Ethical Issues in Predictive Genetic Testing: A Qualitative Analysis
Examining Physician Interactions with Disease Advocacy Organizations
How Payment for Research Participation Can Be Coercive
Thousands of Covid-19 patients have been treated with blood plasma outside of rigorous clinical trials — hampering research that would have shown whether the therapy worked.Full Article
With only limited evidence of effectiveness, the drug should be put to a large clinical trial.Full Article
One way to quickly see if a coronavirus vaccine works would be to immunize healthy people and then deliberately expose them to the virus, some researchers are suggesting. For both ethical and practical reasons, the idea of challenge trials for a coronavirus vaccine has provoked fierce debate.Full Article
The Covid-19 pandemic is unlikely to end until there is a safe, effective, and widely distributed vaccine. How soon can researchers achieve this goal? The answer largely depends on which strategies researchers are willing to adopt. One potential strategy is to conduct human challenge studies, in which researchers give an experimental vaccine to healthy volunteers and then test—or “challenge”—the vaccine by purposely exposing volunteers to the virus. Although a growing number of voices are calling on researchers to employ this strategy, the proposal is generating a heated debate about the ethics of such research.Full Article
More than 25,000 people have volunteered so far to be infected with the novel coronavirus through 1DaySooner, an online recruitment organization, as an aid in testing vaccine candidates to prevent Covid-19. These volunteers know that Covid-19 can cause suffering and even death yet they are stepping forward, willing to risk their lives, because some researchers and academics contend that such experiments in humans could accelerate vaccine development.Full Article
Big questions about ‘challenge trials’ to test vaccines might be addressed while ethical and scientific preparation starts.Full Article
By some measures, it is winning the race, with four companies already testing their vaccine candidates on humans.Full Article
The idea of controlled human infection trials, as they are also called, for Covid-19 research was first raised in late March in an article in the Journal of Infectious Diseases. Since then, the proposal has gained momentum, with other experts making a similar proposal.Full Article
In an bid to help speed up the development of potential treatment options and a vaccine for COVID-19, the National Institutes of Health on Friday announced a new public-private research partnership.Full Article
During public heath emergencies like the Covid-19 pandemic, when no known preventive or effective treatment exists, researchers understandably want to start conducting studies with humans as soon as possible to find a vaccine and therapeutic treatments that are safe and effective. Yet in the rush to find a Covid-19 vaccine and one or more drugs to treat the deadly disease, concerns are being raised that ethical standards for conducting human clinical trials, and the evidentiary standards for determining whether interventions are safe and effective, might be loosened.Full Article