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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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.
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.
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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Academic claims ‘integrity’ of nurse studies often undermined by poor trial registration – Nursing Times (Jo Stephenson | August 2017)0

Posted by Admin in on August 13, 2017

Less than half of clinical trials published in leading nursing journals are officially registered, according to a study, whose authors say their findings raise serious questions about standards and “do not cast the profession in a positive light”.

Study conducted by an Australian clinical researcher highlights why it is essential that new clinical trials are listed with an official registry.

The new research was led by Richard Gray, professor of clinical nursing practice at La Trobe University in Melbourne, Australia, who said trial registration was vital in ensuring that all the evidence about an intervention, drug or treatment was publically available and could be checked and scrutinised.
“It means researchers can’t hide inconvenient results and they can’t change how they report the findings of trials if they don’t get the results they were expecting. In short, registration keeps researchers honest,” he told Nursing Times.

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Research Equity: Overcoming Barriers to Clinical Trials – Oncology Nursing News (Allie Casey | July 2017)0

Posted by Admin in on August 1, 2017

Participation in clinical trials in the United States is much lower than many clinicians would hope. However, this issue is more complicated than patients simply choosing not to participate. Often, there can be barriers to clinical trials that are felt more acutely by patients in minority and other groups like the elderly where comorbidities can be a disincentive to their inclusion.

The low participation rates of minorities in clinical trials can impact on the real world value of the research and is also an equity concern. This very practical discussion piece reflects on how nursing staff can address some of the unspoken reasons for exclusion.

Clinical trials that lack diversity can lead to ethical, as well as efficacy, issues, however. In an interview with Oncology Nursing News, Jennifer A. Wenzel, PhD, RN, CCM, FAAN, associate professor at Johns Hopkins University Schools of Nursing and of Medicine, explains what some of these barriers can look like, why diversity in trials is important, and how nurses can help encourage patients in minority populations to enroll in clinical trials.
Oncology Nursing News: What are some barriers to clinical trials that minority patients can experience?
Wenzel: There are certainly some barriers that affect a lot of people, issues like transportation or concern about income and perhaps the issue of being uninsured or underinsured. These are issues that cut across groups and, as with many things when we look at health disparities, they may impact minority populations more than other groups.

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