Hot Topics: Clinical Trials & Studies

Blog Posts (34)

July 1, 2016

BioethicsTV: The Night Shift Needs More Sleep

by Craig Klugman, Ph.D.

Summer is a slow time for television and especially for the medical drama. One show that has been filling this warm weather slot is The Night Shift, a fairly uninteresting and poorly done drama.…

May 25, 2016

The Potential for Infrastructure Benefits and the Responsiveness Requirement

by David Wendler, PhD

The distribution of resources around the globe is characterized by staggering inequalities and inequities, with the result that individuals in lower income countries have greater disease burden and shorter lives than individuals in high-income countries.…

May 5, 2016

“And Death Shall Be No More”

by Craig Klugman, Ph.D.

Two years after John Donne’s death, the Holy Sonnets were published. In Sonnet 10, Donne speaks about the end of death: “Death, thou shalt die.” Although a metaphorical conceit referring to eternal life in heaven, the poem takes on new meaning in the age of regenerative medicine.…

May 4, 2016

Methodological Miasma not mental dystrophy plagues drug trials

by Arthur Caplan, Ph.D. and Bruce Levin, Ph.D.

The Wall Street Journal and many other media outlets chose to beat on the FDA for its recent decision to deny approval of eteplirsen, a treatment for Duchenne muscular dystrophy being developed by Sarepta Therapeutics.…

April 7, 2016

BioethicsTV: “Heartbeat” tackles therapeutic misconception

by Craig Klugman, Ph.D.

On episode 4 of Heartbeat, the heroine, Dr. Panttiere has received hospital funding to try an experimental cancer treatment on 5 patients.…

April 6, 2016

BIOETHICSTV: Chicago Med-BIID, post mortem egg retrieval, scope of practice and forgiveness

by Craig Klugman, Ph.D.

This week on Chicago Med brought 3 new ethical issues as well as the unsatisfying resolution to a story arc.…

February 29, 2016

A Post-Oscars “Spotlight” on Neonatal Lupus for Rare Disease Day

by Amanda Zink, J.D., M.A. and Jill P. Buyon, M.D.

As national funding decreased in recent decades, medical research suffered. Progress toward uncovering beneficial preventative and therapeutic treatments slowed for thousands of devastating conditions, affecting the health, happiness, and life expectancy of millions of Americans.…

February 25, 2016

Cleveland Clinic Performs First U.S. Uterus Transplant

by Craig Klugman, Ph.D.

Almost like Aphrodite herself, surgeons at the Cleveland Clinic this week may have given fertility to a 26-year-old woman through a 9-hour uterus transplant operation.…

November 2, 2015

A Bioethicist on Mars

by Craig Klugman, Ph.D.

The film, The Martian, is an exciting Robinson Crusoe space adventure. Based on the book of the same name by Andrew Weir, the film stays fairly close to the original source.…

October 12, 2015

Human Subjects Research “Vulnerability”

by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM).…

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Published Articles (8)

AJOB Neuroscience: Volume 7 Issue 2 - Apr 2016

Ethics of Decoded Neurofeedback in Clinical Research, Treatment, and Moral Enhancement Eisuke Nakazawa, Keiichiro Yamamoto, Koji Tachibana, Soichiro Toda, Yoshiyuki Takimoto & Akira Akabayashi

American Journal of Bioethics: Volume 16 Issue 6 - Jun 2016

Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe

American Journal of Bioethics: Volume 16 Issue 6 - Jun 2016

The Potential for Infrastructure Benefits and the Responsiveness Requirement David Wendler

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Quality Improvement Ethics: Lessons From the SUPPORT Study Benjamin S. Wilfond

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Informed Consent and Standard of Care: What Must Be Disclosed Ruth Macklin & Lois Shepherd

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

What Should Be Disclosed to Research Participants? David Wendler

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care David Magnus

News (105)

July 25, 2016 5:04 am

The HIV Trap: A Woman's Lack Of Control (NPR)

When you’re pregnant, going to the doctors can be exciting. You get to find out if you’re having a boy or a girl. Maybe hear the baby’s heart beat. But in southern Africa, many women find out something else.

July 21, 2016 8:41 am

I.V.F. Does Not Raise Breast Cancer Risk, Study Shows (New York Tmes)

Women undergoing in vitro fertilization have long worried that the procedure could raise their risk for breast cancer.

July 18, 2016 9:23 am

Zika Data From the Lab, and Right to the Web (New York Times)

Of the hundreds of monkeys in the University of Wisconsin’s primate center, a few — including rhesus macaque 827577 — are now famous, at least among scientists tracking the Zika virus. Since February, a team led by David H. O’Connor, the chairman of the center’s global infectious diseases department, has been conducting a unique experiment in scientific transparency. The tactic may presage the evolution of new ways to respond to fast-moving epidemics.

July 11, 2016 8:09 am

Juno Halts Cancer Trial Using Gene-Altered Cells After 3 Deaths (New York Times)

Three patients in a study testing the use of genetically engineered cells as a treatment for cancer have died from swelling in the brain, dealing a setback to one of the most exciting pursuits in oncology.

July 1, 2016 8:08 am

Biden threatens funding cuts for researchers who don’t report clinical-trial data (Washington Post)

An impatient Vice President Biden threatened Wednesday to cut funding to research facilities that fail to report clinical-trial results quickly enough and took a swipe at drug companies that jack up the prices of cancer drugs.

June 24, 2016 8:00 am

First CRISPR Human Clinical Trial Gets a Green Light from the U.S. (Scientific American)

CRISPR, the genome-editing technology that has taken biomedical science by storm, is finally nearing human trials.

June 16, 2016 8:06 am

Hints that antibiotics, C-sections may affect baby gut bugs (Washington Post)

Two new studies are offering some of the clearest snapshots yet of how babies build up protective gut bacteria, adding to evidence that antibiotics and birth by C-section may disrupt that development.

June 1, 2016 8:00 am

Why taking morphine, oxycodone can sometimes make pain worse (Science)

There’s an unfortunate irony for people who rely on morphine, oxycodone, and other opioid painkillers: The drug that’s supposed to offer you relief can actually make you more sensitive to pain over time.

May 25, 2016 9:47 am

Despite Pressing Need, Survey Finds Most Americans Unlikely to Enroll in Clinical Trials (Memorial Sloan Kettering Cancer Center)

The lack of participation in clinical research may be the Achilles’ heel of today’s cancer community. According to a new survey of more than 1,500 consumers and nearly 600 physicians conducted on behalf of Memorial Sloan Kettering Cancer Center (MSK), only 35 percent of Americans indicated that they were “likely” to enroll in a clinical trial. Other studies have shown that only 4 percent of cancer patients enroll in clinical trials nationally each year.

May 11, 2016 7:35 am

Malaria Vaccine Shows Strongest Protection Yet (Time)

There’s currently no vaccine for malaria, despite the fact that the disease infects 214 million people per year and kills about half a million. But scientists have been working on a vaccine for some time. Now, a new study reveals that an experimental malaria vaccine can protect adults from malaria for up to a year.

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