Hot Topics: Clinical Trials & Studies

Blog Posts (58)

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.…

August 4, 2017

The Age of Designed Babies Arrives

by Craig Klugman, Ph.D.

In the film Gattaca, a couple desiring to have a child visits their neighborhood geneticist:

Geneticist: You have specified hazel eyes, dark hair and fair skin.

July 19, 2017

Response to: “Rethinking the Belmont Report? Yes!”

by Phoebe Friesen, Lisa Kearns, Barbara Redman, and Arthur L. Caplan

Emily Caldes and Jennifer McCormick make several excellent points in their blog post “Rethinking the Belmont Report?…

July 7, 2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field.

July 6, 2017

Rethinking the Belmont Report?

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field.

July 5, 2017

The Belmont Report: First Word or Last Word on the Foundations of Research Ethics?

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field.

July 3, 2017

Tune Ups to Belmont & Common Rule Need to Consider Community-Engaged Research

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field.

May 8, 2017

Woolgathering: It’s a Bag, It’s a Baby, It’s an Artificial Womb!

by Craig Klugman, Ph.D.

An announcement last week took the science dream of an artificial womb one step closer to science fact: premature lambs were gestated in a biobag (technically an “extra-uterine system”).…

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Published Articles (13)

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

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

News (147)

October 6, 2017 9:00 am

Changes in the microbiota cause genetically modified Anopheles to spread in a population (Science)

In an alternative strategy, Wang et al.engineered mosquitoes’ gut bacteria. A strain of nonpathogenic bacteria, AS1, was both sexually and transgenerationally transmitted. The strain infected a laboratory population of mosquitoes and persisted for at least three generations. AS1 engineered to inhibit malaria parasite development in the midgut could do so without handicapping the mosquitoes.

October 2, 2017 9:00 am

Chinese scientists fix genetic disorder in cloned human embryos (Nature)

A team in China has taken a new approach to fixing disease genes in human embryos. The researchers created cloned embryos with a genetic mutation for a potentially fatal blood disorder, and then precisely corrected the DNA to show how the condition might be prevented at the earliest stages of development.

September 13, 2017 9:00 am

South Korean researchers lobby government to lift human-embryo restrictions (Nature)

More than a decade after a fraud scandal in stem-cell science rocked South Korea, scientists in the field are ramping up pressure on the government to relax the country’s strict regulations on human-embryo research — which many researchers label a ban.

September 7, 2017 9:00 am

Massive Ebola data site planned to combat outbreaks (Nature)

More than 11,000 people died when Ebola tore through West Africa between 2014 and 2016, and yet clinicians still lack data that would enable them to reliably identify the disease when a person first walks into a clinic. To fill that gap and others before the next outbreak hits, researchers are developing a platform to organize and share Ebola data that have so far been scattered beyond reach.

August 9, 2017 9:00 am

Memory-enhancing drug reverses effects of traumatic brain injury in mice (Science)

Whether caused by a car accident that slams your head into the dashboard or repeated blows to your cranium from high-contact sports, traumatic brain injury can be permanent. There are no drugs to reverse the cognitive decline and memory loss, and any surgical interventions must be carried out within hours to be effective, according to the current medical wisdom. But a compound previously used to enhance memory in mice may offer hope: Rodents who took it up to a month after a concussion had memory capabilities similar to those that had never been injured.

August 7, 2017 9:00 am

Senate passes ‘right to try’ bill to help terminally ill patients get experimental drugs (Washington Post)

The Senate on Thursday passed by unanimous consent a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the Food and Drug Administration. The “right-to-try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states. The federal version, now headed to the House, would bar the government from blocking patients from getting access to medications that have undergone only preliminary testing in humans. Patients first would have to try all other available treatments and be unable to participate in clinical trials.

July 17, 2017 9:00 am

Engineered cell therapy for cancer gets thumbs up from FDA advisers (Nature)

External advisers to the US Food and Drug Administration (FDA) have thrown their support behind a therapy that genetically engineers a patient’s own immune cells to target and destroy cancers. In a unanimous vote on 12 July, the panel determined that the benefits of CAR-T therapy outweigh its risks. The vote comes as the agency considers whether to issue its first approval of a CAR-T therapy, for a drug called tisagenlecleucel, manufactured by Novartis of Basel, Switzerland.

June 12, 2017 11:00 am

New clues to why a French drug trial went horribly wrong (Science)

Although Bial and Biotrial have been heavily criticized for the study, French authorities have concluded that the companies did not violate clinical trial regulations. In the wake of the case, the European Medicines Agency is developing stricter rules for “first-in-human” studies.

June 7, 2017 9:00 am

Next-generation cancer drugs boost immunotherapy responses (Nature)

An approach to unleashing immune responses against cancer is showing promise in early clinical trials, and may boost the effectiveness of existing therapies. The experimental drugs target a protein called IDO, which starves immune cells by breaking down the crucial amino acid tryptophan. IDO can suppress immune responses and rein in potentially damaging inflammation. But it can also halt the body’s natural immune response to cancer and allow tumours to grow unchecked.

May 30, 2017 9:00 am

Tissue-independent cancer drug gets fast-track approval from US regulator (Nature)

The US Food and Drug Administration (FDA) has issued its first approval of a cancer drug that targets tumours with specific mutations, regardless of where in the body the tumour first took root. This deviates from the agency’s previous approach: although a drug’s use may have been linked to the presence of a particular molecular marker, the FDA still required individual approvals to deploy that drug based on the tumour’s location. The announcement on 23 May expands the use of pembrolizumab, manufactured by pharmaceutical giant Merck & Co. of Kenilworth, New Jersey. The drug boosts the body’s ability to attack tumours by blocking a protein called PD-1, which normally holds the immune system in check.

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