Hot Topics: Clinical Trials & Studies

Blog Posts (68)

October 1, 2018

Sloan Kettering Controversies: Trust is the Public Foundation of Medical Research

by Ann Mongoven, PhD, MPH

Recent controversies at Memorial Sloan Kettering Cancer Center raise ethical questions about medical research that deserve public attention.…

September 7, 2018

RACeing to Deregulate: Can We Afford Less Oversight of Gene Transfer Research?

by Craig Klugman, Ph.D.

 “As gene therapy continues to change, so must the federal framework set up to oversee it.”-Francis Collins & Scott Gottlieb

In one of his first acts of office, Trump ordered executive agencies to reduce regulations.…

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.…

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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 (175)

October 3, 2018 6:00 pm

Race, Ancestry, and Medical Research (JAMA)

The discussion of race and medicine in the United States is challenging and emotionally charged. Substantial disparities in health outcomes, based on race, ethnicity, and socioeconomic status, continue to exist; additional reports of racial bias and profound insensitivity in research continue to emerge in the popular media. A renewed discussion of race as a biological vs social construct has begun and is complicated by emerging data on genetics, race, and ancestry.

October 2, 2018 9:00 am

Biologists irate at NSF’s new one-proposal cap (Science)

Last month, NSF’s biology directorate announced that researchers could submit only one proposal a year in which they are listed as a principal investigator (PI) or co-PI. The cap applies only to the directorate’s three core tracks and excludes several other NSF programs from which many biologists receive support… But 70 scientists have signed onto a letter asking the agency to reconsider the new policy, which they also complain was adopted without any community input.

October 1, 2018 12:30 pm

Finland joins Europe’s bold open-access push (Nature)

Finland’s national research funder has signed up to Plan S — a push by a group of European organizations to make a radical change to the way that research results are published. The Academy of Finland, which announced its move on 24 September, is the first organization to sign up since Plan S was launched by 11 funders earlier this month. The now 12-strong coalition demands that, from 2020, papers resulting from the research they fund are immediately free to read on publication.

September 26, 2018 9:00 am

As China builds biotech sector, cash floods U.S. startups (Reuters)

Brii is one of many biotech startups riding a wave of money from Asia that so far this year has poured $4.2 billion into private U.S.-based biotech companies. That is over 43 percent of the total amount of venture funding invested in the biotech sector, according to PitchBook, up from just 11 percent in 2016.

September 20, 2018 6:00 am

Are We Being Misled About Precision Medicine? (The New York Times)

Doctors and hospitals love to talk about the cancer patients they’ve saved, and reporters love to write about them. But deaths still vastly outnumber the rare successes.

September 7, 2018 2:07 am

New gene-editing treatment might help treat a rare disorder, hints first human test (Science)

The first test of a new gene-editing tool in people has yielded early clues that the strategy—an infusion that turns the liver into an enzyme factory—could help treat a rare, inherited metabolic disorder. Today, the biotech company Sangamo Therapeutics in Richmond, California, reported data suggesting that two patients with Hunter syndrome are now making small amounts of a crucial enzyme that their bodies previously could not produce. But the company is still a long way from providing evidence that the new method can improve Hunter patients’ health.

August 31, 2018 9:00 am

Massive £30-million grant will be awarded to one cardiovascular research team (Nature)

A lucky group of researchers will soon walk away with £30 million (US$39 million) to study the heart and circulatory system — one of the largest single grants for medical research in the world. The British Heart Foundation (BHF) launched the award on 25 August, and it is open to international applicants.

August 20, 2018 9:00 am

Researcher at the center of an epic fraud remains an enigma to those who exposed him (Science)

The first thing that went through Alison Avenell’s head when she heard Yoshihiro Sato had died was that it might be a trick. It was March 2017, and in the previous years, Avenell, a clinical nutritionist at the University of Aberdeen in the United Kingdom, had spent thousands of hours combing through Sato’s papers, together with three colleagues in New Zealand. They had discovered that Sato, a bone researcher at a hospital in southern Japan, had fabricated data for dozens of clinical trials published in international journals. “With so much going on, so much fabrication, you just wonder if it’s convenient for the person to go and hide,” Avenell says.

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.

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