Hot Topics: Clinical Trials & Studies

Blog Posts (65)

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.…

September 6, 2017

Response to the Common Rule Special Issue: Attention to Health Disparities

by Nicolle K. Strand, JD, MBioethics, and Nora Jones, PhD

The article and commentaries on recent revisions to the Common Rule published in the July 2017 issue of AJOB are missing, we believe, a key perspective.…

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Published Articles (15)

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

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

The Potential for Infrastructure Benefits and the Responsiveness Requirement David Wendler

News (162)

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.

April 11, 2018 3:00 am

U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks (Annals of Internal Medicine)

In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product’s widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.

April 6, 2018 9:00 am

To treat some diseases, researchers are putting immune cells on a diet (Science)

Once triggered into action, an immune cell overhauls its metabolism, making changes that could be exploited for treatment.

April 2, 2018 1:53 pm

False-positive results released by direct-to-consumer genetic tests highlight the importance of clinical confirmation testing for appropriate patient care (Nature)

There is increasing demand from the public for direct-to-consumer (DTC) genetic tests, and the US Food and Drug Administration limits the type of health-related claims DTC tests can market. Some DTC companies provide raw genotyping data to customers if requested, and these raw data may include variants occurring in genes recommended by the American College of Medical Genetics and Genomics to be reported as incidental/secondary findings. The purpose of this study was to review the outcome of requests for clinical confirmation of DTC results that were received by our laboratory and to analyze variant classification concordance.

March 29, 2018 9:00 am

The Struggle to Build a Massive ‘Biobank’ of Patient Data (The New York Times)

The goal is to find one million people in the United States, from all walks of life and all racial and ethnic groups, who are willing to have their genomes sequenced, and to provide their medical records and regular blood samples.

They may choose to wear devices that continuously monitor physical activity, perhaps even devices not yet developed that will track heart rate and blood pressure. They will fill out surveys about what they eat and how much.

If all goes well, experts say, the result will be a trove of health information like nothing the world has seen. The project, called the All of Us Research Program, should provide new insights into who gets sick and why, and how to prevent and treat chronic diseases.

February 26, 2018 9:00 am

World's first human-sheep hybrids pave way for diabetes cure and mass organ transplants (The Telegraph)

The next step is to implant human stem cells into sheep embryos which have been genetically modified so they cannot grow a pancreas, in the hope that human DNA will fill in the missing code. If successful a human pancreas should appear inside the animal’s body. The team is about to apply for permission from regulators to lengthen their experiment to 70 days to see if the human cells really can create an organ.

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