ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) FDA and NIH let clinical trial sponsors keep results secret and break the law – Science (Charles Piller | January 2020)0

Posted by Admin in on January 21, 2020
 

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Failing to report the results of clinical trials have two serious consequences: 1. It can hide from clinicians and other health professionals problems with a new agent/device/technique. 2. It is wasteful of time/resources because other reseachers might try to conduct the same trial, not realising it had already failed.  So it is very concerning these two regulatory agencies are failing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.
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The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.
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Google health-data scandal spooks researchers – Science (Heidi Ledford | November 2019)0

Posted by Admin in on January 12, 2020
 

Scientists fear the controversy over the Nightingale project will undermine trust in research.

Google and one of the largest health-care networks in the United States are embroiled in a data-privacy controversy that researchers fear could jeopardize public trust in data-sharing practices and, potentially, academic studies.

At issue is a project dubbed Nightingale that gives Google access to the health-care information, including names and other identifiable data, of tens of millions of people without their knowledge. The people were treated at facilities run by the health network Ascension, which is based in St Louis, Missouri.

Google says that Nightingale, first reported in The Wall Street Journal on 11 November, is meant to develop technology that would enable Ascension to deliver improved health care.

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(China/Gene) Chinese scientist who produced genetically altered babies sentenced to 3 years in jail – Science (Dennis Normile | December 2019)0

Posted by Admin in on January 5, 2020
 

He Jiankui, the Chinese researcher who stunned the world last year by announcing he had helped produce genetically edited babies, has been found guilty of conducting “illegal medical practices” and sentenced to 3 years in prison.

Given the degree of recklessness and premeditation, the lifetime health effects and that the genetic modifications are inheritable, some may feel an even harsher sentence would have been warranted.  Nevertheless, it is welcome to see the Chinese court impose large fines and prison sentences.

A court in Shenzhen found that He and two collaborators forged ethical review documents and misled doctors into unknowingly implanting gene-edited embryos into two women, according to Xinhua, China’s state-run press agency. One mother gave birth to twin girls in November 2018; it has not been made clear when the third baby was born. The court ruled that the three defendants had deliberately violated national regulations on biomedical research and medical ethics, and rashly applied gene-editing technology to human reproductive medicine.
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All three pleaded guilty, according to Xinhua. The court also fined He, formerly of the Southern University of Science and Technology (SUSTech) and known as JK to friends and colleagues, 3 million Chinese yuan ($429,000). His collaborators were identified as Zhang Renli, of a medical institution in Guangdong province, and Qin Jinzhou, from a Shenzhen medical institution; Zhang received a 2-year prison sentence and was fined 1 million yuan, according to Xinhua, whereas Qin was given 18 months in prison with a 2-year reprieve, and a 500,000 yuan fine.
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How about personally optimized treatment? – The Ethics Blog (Pär Segerdahl | March 2019)0

Posted by Admin in on December 31, 2019
 

It is well known that patients who are asked to participate in cancer trials are tempted by the therapeutic misconception. They believe they are offered a newer and better treatment, when in fact it is about research into an untested treatment. When researchers use genetic tests to develop personalized oncology, even more misconceptions can arise. I will soon explain. But first, what is personalized cancer treatment? Here is an example.

Patients whose tumor is to be operated may undergo preparatory radiation or chemotherapy. Since the preparatory therapy has severe side effects, one wants to avoid giving it to patients whose tumors do not respond to it. The challenge is to distinguish patients who respond to treatment from patients who do not. This is to be accomplished through, among other things, genetic tests on the tumor cells. If this works, you can develop personalized cancer treatment. Patients with the “right” tumor cell genetics receive the preparatory therapy, while patients who, according to the genetic tests, only get the side effects, with no effect on tumor growth, do not receive the therapy.

What are the misconceptions that can arise in patients who are asked to participate in research on personalized cancer treatment? Here are some examples.

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