Hot Topics: Clinical Trials & Studies

Blog Posts (49)

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).…

January 19, 2017

New Common Rule Regs Mean New Training for IRB Members

by Craig Klugman, Ph.D.

Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule.…

January 13, 2017

BioethicsTV: Violating confidentialty, ethical decision-making, unapproved human experimentation

by Craig Klugman, Ph.D.

Chicago Med (Season 2; Episode 10): In this episode a heart patient returns from a previous episode when a heart is found for a transplant.…

January 10, 2017

Be Wary What You Research: You Might Get Sued

by Craig M. Klugman, Ph.D.

Peter Cohen, Clayton Bloszies, Caleb Yee and Roy Gerona published an article in the journal Drug Testing and Analysis in April 2015 explaining the results of their testing of supplements.…

January 6, 2017

BioethicsTV (January 2-6, 2017): Violating promises, coma v. PVS, transplant evaluation, and whether to abort

by Craig Klugman, Ph.D.

Pure Genius (Season1; Episode 10- 1/5). In this episode, Dr. Channarayapatra is working with a patient in lung failure.…

November 9, 2016

Bioethics faces a rocky but navigable road

by Arthur Caplan, Ph.D.

Academic bioethics has never been popular with Republicans.  Libertarians dislike academic bioethics because it seems too elitist and anti-free market. …

November 9, 2016

President Trump & A Republican Congress: What Might It Mean?

by Craig Klugman, Ph.D.

In a 2000 episode of The Simpsons, a flash forward shows Lisa being elected the first heterosexual female U.S.…

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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 (140)

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.

May 1, 2017 9:00 am

Human vaccine data release jump-starts biotech’s bid for RNA drugs (Science)

The executive team at Moderna raised a cheer today after publishing their first early snapshot of human efficacy data that demonstrate their messenger RNA tech works — at least on the first try. The biotech tested their H10N8 flu vaccine on a small group of 31 subjects, looking at their response in two different measures. All demonstrated a sufficient immune response to fight off the virus in the first measure, and all but 3 in the second, for a total of 23 who received the vaccine.  None of the 8 subjects who received a placebo responded.

April 24, 2017 9:00 am

CRISPR studies muddy results of older gene research (Nature)

Scientists face tough decisions when the latest gene-editing findings don’t match up with the results of other techniques.

April 18, 2017 1:08 pm

Exercise is contagious, especially if you’re a man (Science)

They found that as people in cities with nice weather went for especially long runs, their friends in unaffected cities would extend their own runs, increasing their running distance and time and burning more calories. That suggests that at least some of that extra exercise is thanks to social influence, the researchers write today in Nature Communications. Men appeared more susceptible than women: They were strongly affected by male friends and moderately affected by female friends, whereas women were moderately affected by other women and unaffected by men.

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