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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Clinical trials: how to make informed consent more ethical – The Conversation (Jeremy Howick | February 2020)0

Posted by Admin in on February 19, 2020
 

It has been illegal to treat humans like guinea pigs since the Nuremberg trials, in which Nazi doctors were punished for doing unspeakable things to prisoners. These days, we have to explain the experiment to the people taking part in trials for new treatments and get their permission (their “informed consent”).

A fascinating discussion and useful suggestions.

Specifically, we have to tell them about the risks of taking part. So in a trial of a new drug, we have to tell patients about all the possible side-effects. In ethical geek-speak, we have to preserve patients’ autonomy by giving them enough information to make an autonomous decision. Which is fine, up to a point.
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It is also an ethical requirement to avoid unnecessarily harming patients. A recent study published in the BMJ Journal for Medical Ethics shows that the relatively recent discovery of so-called nocebo effects – a result of the patient’s expectation that the treatment will harm them – means that harm is being done by the way we inform patients about the trial in which they are taking part.
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‘Evidence-Based Medicine’ and the Expulsion of Peter Gøtzsche – Medscape (Daniel Kolitz | December 2019)0

Posted by Admin in on February 13, 2020
 

FOR EIGHT MONTHS in 1975, Peter Gøtzsche recalls driving around Denmark misleading doctors about a new, more expensive type of penicillin. He was 25 years old, with master’s degrees in biology and chemistry. As a pharmaceutical representative for the Sweden-based Astra Group, he was tasked with promoting Globacillin, which was said to be more effective than regular penicillin. At the time, Gøtzsche says he did not know that the claims he was making on behalf of his employer were not backed by high-quality evidence.

Gøtzsche stayed in the pharmaceutical industry for another eight years, writing brochures, strategizing ad campaigns, and, eventually, presiding over clinical trials. It was here that disillusionment set in. Gøtzsche — in his telling, still a principled naïf — would watch with dismay as his superiors twisted or suppressed any unflattering trial results. Increasingly distraught, Gøtzsche began pursuing a medical degree, leaving the industry for good in 1983.

His medical thesis, titled “Bias in Double-Blind Trials,” examined the claims of 244 reports of clinical trials for non-steroidal anti-inflammatory drugs, a group that includes ibuprofen and aspirin. Gøtzsche’s writing strongly critiqued the marketing practices of his former employer, Astra-Syntex, pointing out that no good evidence existed for their claim that the higher the dose, the better the effect.

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(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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Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)0

Posted by Admin in on January 7, 2020
 

Abstract
Comparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

KEYWORDS:
Human subjects research; IRB (Institutional Review Board); informed consent; risk/benefit analysis

Macklin, R. & Natanson, C. (2019) Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error. Americaan Journal of Bioethics. 20(1):31-39. doi: 10.1080/15265161.2019.1687777.
Publisher: https://www.tandfonline.com/doi/full/10.1080/15265161.2019.1687777

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