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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Why the ‘gold standard’ of medical research is no longer enough – STAT (Tom Frieden | August 2017)0

Posted by Admin in on August 31, 2017
 

Randomized controlled trials have long been held up as the “gold standard” of clinical research. There’s no doubt that well-designed trials are effective tools for testing a new drug, device, or other intervention. Yet much of modern medical care — perhaps most of it — is not based on randomized controlled trials and likely never will be. In this “dark matter” of clinical medicine, past practices and anecdotes all too often rule. We need to look beyond trials to improve medical care in these areas.

The primary reason we included this item in the Resource Library was because we thought the examples useful.

In a randomized controlled trial (RCT), participants are randomly assigned to receive either the treatment under investigation or, as a control, a placebo or the current standard treatment. The randomization process helps ensure that the various groups in the study are virtually identical in age, gender, socioeconomic status, and other variables. This minimizes the potential for bias and the influence of confounding factors.
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Despite their strengths, RCTs have substantial limitations. They can be very expensive to run. They can take many years to complete, and even then may not last long enough to assess the long-term effect of an intervention such as vaccine immunity, or to detect rare or long-term adverse effects. Findings from RCTs may not be valid beyond the study population — a trial that included a high-risk population in order to maximize the possibility of detecting an effect, for example, may not be relevant to a low-risk population. RCTs may not be practical for population-wide interventions and often aren’t relevant for urgent health issues such as infectious disease outbreaks, for which public health decisions must be made quickly.
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NYC’s forgotten cancer scandal – New York Post (Allen M. Hornblum | December 2013)0

Posted by Admin in on August 29, 2017
 

The front-page headline of the New York World-Telegram on Jan. 20, 1964 shocked readers: “Charge Hospital Shot Live Cancer Cells Into Patients.”

The stunning accusation was that Brooklyn’s Jewish Chronic Disease Hospital, a facility known for serving an elderly population and those in need of long-term physical care, was “conducting cancer experiments on unsuspecting non-cancerous patients.”

Selwyn Raab, who was a new hire at the old World-Telegram when an editor assigned him to check out a tip about some research shenanigans at a Brooklyn hospital, was admittedly “astonished” by the allegations.

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Read the original news story from 1964

Egregious ethical lapses from the past can be useful vignettes/springboards for workshop discussion but they shouldn’t be used as justification of why research ethics review arrangements exist. The former can get attendees thinking and talking about research ethics the latter runs the risk of reinforcing that human research ethics is about punishing 99.9% for the awful misdeeds of the reckless minority from decades ago.

MCI Suspends 8 Indore doctors’ Registration Over Unethical Drug Trial – News18 (Vivek Trivedi | August 2017)0

Posted by Admin in on August 24, 2017
 

The Ethical Committee of MCI issued the order to suspend the doctors including a hospital superintendent and former superintendent for a period of three months.

This news story is a valuable example of a link between research and professional practice regulation

Indore: Seven years after it was found that several doctors at the state-run Mahatma Gandhi Medical College (MGMC) were involved in unethical drug trial on unsuspecting patients, the Medical Council of India finally suspended the registration of eight doctors.
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The Ethical Committee of MCI issued the order on Thursday to suspend the doctors including the superintendent and former superintendent for a period of three months.
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Grantees, Reveal Thy Findings: A Push By Funders for Transparency in Medical Research – Inside Philanthropy (Till Bruckner | July 2017)0

Posted by Admin in on August 20, 2017
 

In an effort to combat research waste and speed up the discovery of new drugs, medical research funders have pledged to cut off funding to grantees who fail to meet basic transparency standards. To date, over a dozen funders, including heavy hitters like the Bill & Melinda Gates Foundation and the U.K.’s Wellcome Trust, have signed a joint statement demanding that their grantees publicly disclose the results of all clinical trials within 12 months.

We thought this a persuasive piece and a message worth heeding (and repeating). Often it is the sponsors of clinical trials who are blamed for the delayed release of research outputs so this push is welcome and very much in the public interest.

“Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed,” commented Dr. Marie-Paule Kieny, assistant director-general for Health Systems and Innovation at the World Health Organization (WHO), whose standards the statement is based on.
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Clinical trials conducted in human patients are the keystone of modern medicine. Typically, a clinical trial examines whether a new drug, medical device or procedure is safe and effective at improving patient health. Every year, pharmaceutical companies, government agencies, foundations and nonprofits pour billions of dollars into trials in the hope of discovering new vaccines, treatments and cures. However, around half of all clinical trials never report their results, and many others are badly reported, making no contribution to medical progress. Scientists have warned that as a result, a mind-boggling $170 billion in medical research funding is being wasted every year.
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