Hot Topics: Clinical Trials & Studies

Blog Posts (66)

July 11, 2018

Secret Twin Experiments & Bioethics.net 15 seconds of fame

by Craig Klugman, Ph.D.

On the advice of a family friend, I went to see the new documentary, Three Identical Strangers.

May 8, 2018

Speaking to the Media about Antimicrobial Resistance: A Deeper Description of How I Wear Many Hats as a Bioethicist

by Craig Klugman, Ph.D.

Last week, I was interviewed by an academic news serviceabout antimicrobial resistance (AMR) after a study reported that giving antibiotics to children in selected African towns led to a decreased mortality rate.  …

April 6, 2018

BioethicsTV (April 2-6): #ChicagoMed; #GreysAnatomy

by Craig Klugman, Ph.D.

Chicago Med (Season 3; Episode 14): Record checking; off label use; scope of practice; Grey’s Anatomy (Season 14; Episode 18): Experimental treatment; Saying goodbye

Chicago Med (Season 3; Episode 14): Record checking; off label use; scope of practice
Psychiatry resident Dr.…

February 21, 2018

Insider Report: NIH Alters Pre-Award Human Subjects Concerns Reporting; IRBs Not Told

by Craig Klugman, Ph.D.

On February 16, 2018, bioethics.net received an NIH memo sent to program officers on the same day.…

February 14, 2018

Is a Vitamin D placebo trial in children with asthma ethical?

by Craig Klugman, Ph.D.

In a 2017 article from India, researchers conducted a meta-analysis looking at vitamin D deficiency and asthma in children.…

January 25, 2018

Monkey See, Human Do: Cloning Macaque Monkeys with Fetal Cells

by Craig Klugman, Ph.D.

 “How afraid of human cloning should we be?”
Monkeys have been cloned, Paving the way for human cloning
Yes, They’ve Cloned Monkeys in China.

January 9, 2018

Blindness Cure Is Out of Sight

by Craig Klugman, Ph.D.

The FDA has approved the world’s first gene therapy: Luxturna (voretigene neparvovec; AAV2-hRPE65v2) is a one-time intervention that can treat an inherited retinal disease (RPE65-mediated inherited retinal dystrophy).…

January 5, 2018

BioethicsTV (December 29, 2017-January 5, 2018): Medical Research and Consent for Testing

by Craig Klugman, Ph.D.

Black Mirror (Seasons 4; Episode 6): Medical research

In this British series exploring the potential nightmares of modern technology, this episode looked at three stories of research ethics in medicine.…

November 1, 2017

Rand Paul is About to Legislate Peer-Review: Scientists Need Not Apply

by Craig Klugman, Ph.D.

Senator and former Presidential candidate Rand Paul introduced S. 1973, a bill that would change how scientific grant proposals are reviewed.…

October 13, 2017

BioethicsTV (October 9-13, 2017): Drinking on transplant list; big pharma in pandemics; mortality forces morality

The Good Doctor (Season 1; Episode 3): A Patient Takes A Drink While on the Transplant List

This week, a patient is finally at the top of the list for a heart transplant.…

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Published Articles (16)

American Journal of Bioethics: Volume 18 Issue 7 - Jul 2018

On Gender and Reproductive Decision-Making in Uterine Transplantation Hilary Mabel, Ruth M. Farrell & Andreas G. Tzakis

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials Lisa McManus & Jill A. Fisher

American Journal of Bioethics: Volume 18 Issue 4 - Apr 2018

Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility Nancy S. Jecker, Aaron G. Wightman, Abby R. Rosenberg & Douglas S. Diekema

AJOB Neuroscience: Volume 8 Issue 2 - Jun 2017

Staying in the Loop: Relational Agency and Identity in Next-Generation DBS for Psychiatry Sara Goering, Eran Klein, Darin D. Dougherty & Alik S. Widge

AJOB Primary Research: Volume 8 Issue 3 - Sep 2017

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents Amelia S. Knopf , Amy Lewis Gilbert , Gregory D. Zimet, Bill G. Kapogiannis, Sybil G. Hosek, J. Dennis Fortenberry, Mary A. Ott & The Adolescent Medicine Trials Network for HIV/AIDS Interventions

American Journal of Bioethics: Volume 17 Issue 5 - May 2017

Ethical Issues in Fecal Microbiota Transplantation in Practice Yonghui Ma, Jiayu Liu, Catherine Rhodes, Yongzhan Nie & Faming Zhang

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Decision making in pediatric oncology: Views of parents and physicians in two European countries Domnita O. Badarau, Katharina Ruhe, Thomas Kühne, Eva De Clercq, Anca Colita, Bernice S. Elger & Tenzin Wangmo

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Better to know than to imagine: Including children in their health care Tenzin Wangmo, Eva De Clercq, Katharina M. Ruhe, Maja Beck-Popovic, Johannes Rischewski, Regula Angst, Marc Ansari & Bernice S. Elger

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

News (167)

August 15, 2018 9:00 am

Bayer shares slide after Monsanto's Roundup cancer trial (Reuters)

Shares in Bayer (BAYGn.DE) plunged more than 10 percent to their lowest in almost two years after a California jury ordered the German company’s subsidiary Monsanto to pay $289 million in damages last week.

July 18, 2018 9:09 am

Are 'breakthrough' drugs as safe as other FDA-approved medicines? (CNN)

New research questions the quality of drugs given the “breakthrough therapy” designation by the US Food and Drug Administration. In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental medicines intended to treat serious or life-threatening conditions.

July 18, 2018 5:42 am

Editing human embryos 'morally permissible' (BBC News)

Should we or shouldn’t we be allowed to modify human DNA in future children? An inquiry into the ethical issues surrounding genetically altering a human embryo has found there is “no absolute reason not to pursue it”. But appropriate measures must be put in place before it becomes UK law, said the report – which calls for further research both medically and socially. Inquiry chair, Prof Karen Yeung, said: “The implications for society are extensive, profound and long-term.”

July 17, 2018 7:22 am

Please Don’t Take Prescription Drug Advice from Kim Kardashian (Leapsmag)

Legislators and patients often wonder why the cost of drugs in America is so high relative to the rest of the world. Well, one reason is the rest of the world does not tolerate direct-to-consumer ads aimed at ginning up demand when touted by actors, soap opera stars, sports stars, reality tv icons, quiz show hosts and others selling their fame so you will use a company’s drug.

July 16, 2018 3:04 am

Drug to Treat Smallpox Approved by F.D.A., a Move Against Bioterrorism (The New York Times)

The Food and Drug Administration on Friday approved the first drug intended to treat smallpox — a move that could halt a lethal pandemic if the virus were to be released as a terrorist bioweapon or through a laboratory accident.

June 18, 2018 11:16 am

Controversial NIH study of ‘moderate drinking’ will be terminated after scathing report (STAT)

The group examining the Moderate Alcohol and Cardiovascular Health (MACH) Trial also found that, starting in 2013, “there was early and frequent engagement” between NIH officials and the alcohol industry that appeared to be “an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members.”

June 4, 2018 9:00 am

Most women with a common type of early-stage breast cancer can skip chemo, a new report finds (Washington Post)

The cancer in question is driven by hormones, has not spread to the lymph nodes and does not contain a protein called HER2. Generally, after surgery, such patients receive endocrine therapy, such as tamoxifen, which is designed to block the cancer-spurring effects of hormones. Otis Brawley, chief medical and scientific officer of the American Cancer Society, called the trial a good example of “precision medicine” and said it would save many women from unneeded chemotherapy.

May 30, 2018 9:00 am

‘Reprogrammed’ stem cells approved to mend human hearts for the first time (Nature)

On 16 May, Japan’s health ministry gave doctors the green light to take wafer-thin sheets of tissue derived from iPS cells and graft them onto diseased human hearts. The team, led by cardiac surgeon Yoshiki Sawa at Osaka University, says that the tissue sheets can help to regenerate the organ’s muscle when it becomes damaged, a symptom of heart disease that can be caused by a build-up of plaque or by a heart attack.

April 25, 2018 9:00 am

FDA investigating unauthorized herpes vaccine research (CNN)

Since 1995, Halford had been conducting and publishing research on the herpes simplex virus, for which he had received small grants from the National Institutes of Health. But the biology professor at Southern Illinois University had run out of time. Diagnosed in 2011 with sinonasal undifferentiated carcinoma, a rare form of cancer, Halford knew that he might not be able to complete development of his vaccine and gain approval from the US Food and Drug Administration before his life ended. In fact, when Halford died of cancer in June at the age of 48, his vaccine had not cleared all the regulatory hurdles necessary for a medical product to be approved for use in the US. Now, the FDA has launched a criminal investigation into Halford’s research practices, according to a report by Kaiser Health News.
April 11, 2018 9:00 am

Squeaky clean mice could be ruining research (Nature)

On an unseasonably warm February morning, Mark Pierson takes a 20-minute drive to one of Minneapolis’s larger pet shops. Pierson, a researcher in an immunology laboratory at the University of Minnesota, often comes here to buy mice, so most of the staff know him. Today he asks for ten, and an employee fishes them out of a glass box. Pierson requests the smaller mice because they’re typically younger, but he isn’t too picky. They probably all have what he wants: germs.

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