Hot Topics: Clinical Trials & Studies

Blog Posts (33)

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).…

October 5, 2015

Your Biology is in My Technology

by Craig Klugman, Ph.D.

The PBS series Open Mind has been on television for nearly 60 years. The program “is a thoughtful excursion into the world of ideas.” The December 30 episode was an interview with Dr.

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Published Articles (7)

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 (99)

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.

May 5, 2016 9:46 am

Bacteria-Infected Mosquitoes Could Slow Spread of Zika Virus (New York Times)

If there is ever a contest for Least Appreciated Creature on Earth, first prize should go to a microbe called Wolbachia. The bacterium infects millions of invertebrate species, including spiders, shrimps and parasitic worms, as well as 60 percent of all insect species. Once in residence, Wolbachia co-opts its hosts’ reproductive machinery and often greedily shields them from a variety of competing infections.

April 20, 2016 9:53 am

Loneliness can harm your heart, study finds

Loneliness and social isolation can take a toll on health in a number of ways, and new research shows it may seriously damage the heart. While loneliness has previously been linked to high blood pressure, a compromised immune system, and even an early death, its relationship to heart problems like cardiovascular disease and stroke wasn’t as clear.

April 19, 2016 8:53 am

Study Backs Pancreas Cell Transplants for Severe Diabetes

Transplants of insulin-producing pancreas cells are a long hoped-for treatment for diabetes — and a new study shows they can protect the most seriously ill patients from a life-threatening complication of the disease, an important step toward U.S. approval.

March 29, 2016 8:42 am

Blood Test for Concussions? Researchers Report Some Progress

New research bolsters evidence that a simple blood test may someday be used to detect concussions. It suggests that a protein linked with head trauma may be present in blood up to a week after injury, which could help diagnose patients who delay seeking treatment.

March 28, 2016 11:46 am

Choosing to die at home does not hasten death for patients with terminal cancer

A large study from Japan found that cancer patients who died at home tended to live longer than those who died in hospitals. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings suggest that oncologists should not hesitate to refer patients for home-based palliative care simply because less medical treatment may be provided.

January 16, 2016 6:21 pm

French Drug Trial Disaster Leaves One Brain Dead, Five Injured

One person has been left brain dead and five others are in serious condition after taking part in the clinical trial of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

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