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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

How a simple ‘thank you’ could improve clinical trials – Nature (Editorial | November 2018)0

Posted by Admin in on December 11, 2018
 

Everyone would benefit if researchers did more to make participants feel part of a study.

When researchers at the drug giant Pfizer wanted to improve their clinical trials, the people who had taken part had a clear suggestion: researchers should say thank you.

It is a simple request, but a revealing one. When a clinical trial is completed, many participants walk away empty-handed. Most never hear from the investigators or the trial’s sponsor again. Many do not learn the results of the study in which they took part. It’s not good enough — and it indicates a deeper problem.

As we discuss in a News Feature this week, clinical-trial participants and the people who care for them are increasingly seen as partners in research. They are more informed than ever about their conditions and their medical options. And they are demanding — and receiving — more of a say in how clinical trials are designed and conducted. Some of this activity has been boosted by social media, which has allowed people with medical conditions and their carers to band together, share their experiences and advocate for change.

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What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry – New York Times (Charles Ornstein and Katie Thomas | December 2018)0

Posted by Admin in on December 10, 2018
 

One is dean of Yale’s medical school. Another is the director of a cancer center in Texas. A third is the next president of the most prominent society of cancer doctors.

These leading medical figures are among dozens of doctors who have failed in recent years to report their financial relationships with pharmaceutical and health care companies when their studies are published in medical journals, according to a review by The New York Times and ProPublica and data from other recent research.

Dr. Howard A. “Skip” Burris III, the president-elect of the American Society of Clinical Oncology, for instance, declared that he had no conflicts of interest in more than 50 journal articles in recent years, including in the prestigious New England Journal of Medicine.

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The Ethical Quandary of Human Infection Studies – Undark (Linda Nordling | November 2018)0

Posted by Admin in on December 4, 2018
 

Sometimes infecting volunteers with a disease can lead to new treatments. But how much risk and compensation is acceptable for those in poor nations

IN FEBRUARY OF last year, 64 healthy adult Kenyans checked into a university residence in the coastal town of Kilifi. After a battery of medical tests, they proceeded, one by one, into a room where a doctor injected them with live malaria parasites. Left untreated, the infection could have sickened or even killed them, since malaria claims hundreds of thousands of lives every year.

This excellent piece about researchers from affluent countries conducting ‘infection studies’ in poor countries raises issues you might not have considered.

But the volunteers — among them casual laborers, subsistence farmers, and young mothers from nearby villages — were promised treatment as soon as infection took hold. They spent the next few weeks sleeping, eating, and socializing together under the watchful eye of scientists, giving regular blood samples and undergoing physical exams. Some grew sick within a couple of weeks, and were treated and cleared of the parasite before being sent home. Those who did not fall ill were treated after three weeks as a precaution and discharged, too.
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As compensation, the volunteers received between $300 and $480 each, or roughly $20 a day, a rate based on the minimum wage for casual laborers in Kenya and the out-of-pocket allowance set for overnight stays by KEMRI, the Kenya Medical Research Institute.
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Why do medical journals keep taking authors at their word? – STAT (Ivan Oransky | September 2018)0

Posted by Admin in on November 29, 2018
 

The recent revelation that a leading official at Memorial Sloan Kettering Cancer Center failed for years to disclose lucrative financial conflicts of interest might have been surprising in its scale. But it’s old news that many researchers aren’t fully transparent when it comes to their financial relationships with industry.

So why should we keep up the charade? And why, given the clarity of the problem, do medical journals continue to take authors at their word — only to wind up looking like dupes?

According to an investigation by ProPublica and The New York Times, Dr. José Baselga — who was chief medical officer of the venerable cancer clinic until resigning Thursday — has what can charitably be described as an inconsistent personal policy on revealing companies that have given him cash or other potentially lucrative fillips. Baselga also has stayed mum about his conflicts of interest — which also involve research funding and seats on advisory boards — in many of his publications, including those in high-rent titles like the New England Journal of Medicine, and despite policies from the journals demanding that authors reveal such relationships.

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