Hot Topics: Clinical Trials & Studies

Blog Posts (55)

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”).…

March 31, 2017

BioethicsTV: Aggressive Treatment Chosen for Patients at the End of Life

by Craig Klugman, Ph.D.

This week’s Thursday night medical TV was all about end of life decision-making and delved into the questions of how much aggressive treatment is too much, what happens when physicians lose clinical distance, and who makes decisions for patients.…

February 16, 2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

by Steven H. Miles, MD

Bioethicist Steven Miles suggest that making the new Common Rules regulations easy to read is as important as the content

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.…

February 3, 2017

A Solution In Search of A Problem: Streamlining the FDA

by Craig Klugman, Ph.D.

A professional association for regulatory affairs posted an article on Wednesday reporting Trump’s comments “calling for a massive overhaul of US Food and Drug Administration (FDA) regulations.” Trump issued an executive that called for reducing the number of federal regulations (for each new one created, two must be retired).…

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Published Articles (11)

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

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

News (143)

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.

May 24, 2017 9:00 am

Safety and immunogenicity of a live attenuated influenza H5 candidate vaccine strain A/17/turkey/Turkey/05/133 H5N2 and its priming effects for potential pre-pandemic use: a randomised, double-blind, placebo-controlled trial (The Lancet)

The emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost.

May 19, 2017 9:00 am

For Tuskegee Syphilis Study Descendants, Stigma Hasn't Faded (The New York Times)

For 40 years starting in 1932, medical workers in the segregated South withheld treatment for unsuspecting men infected with a sexually transmitted disease simply so doctors could track the ravages of the horrid illness and dissect their bodies afterward. Finally exposed in 1972 , the study ended and the men sued, resulting in a $9 million settlement. Twenty years ago this May, President Bill Clinton apologized for the U.S. government. It seemed to mark the end of this ugly episode, once and for all. Except it didn’t.

May 17, 2017 9:00 am

Will vaccine help curb new Ebola outbreak in the DRC? (Science)

Ebola has surfaced in a remote part of the Democratic Republic of the Congo (DRC), the first outbreak of the disease since the West African epidemic that killed more than 11,000 people before it came to an end 2 years ago. A vaccine proved its worth in the West African epidemic—which hit major cities—but it still is awaiting approval from regulatory agencies, and the DRC government has yet to request its use for this outbreak.

May 4, 2017 9:00 am

NIH to limit the amount of grant money a scientist can receive (Nature)

For the first time, the US National Institutes of Health (NIH) will restrict the amount of funding that an individual scientist can hold at any one time, based on a new point system. The move, announced on 2 May, is part of an ongoing effort to make obtaining grants easier for early and mid-career scientists, who face much tougher odds than their more-experienced colleagues.

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