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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(COVID-19) Underpromise, overdeliver – Science (Editorial – H. Holden Thorp | March 2020)0

Posted by Admin in on April 27, 2020
 

The majority of crises that most of us have lived through have not looked to science for immediate answers. In many cases, much of the scientific analysis came after the fact—the effects of climate change on extreme weather events; the causes of nuclear accidents; and the virology of outbreaks that were contained such as severe acute respiratory syndrome (SARS) in 2002–2003 or Middle East respiratory syndrome (MERS) in 2012. Now, science is being asked to provide a rapid solution to a problem that is not completely described.

Rather than being just being for the COVID-19 work that is currently very much in the public’s eye at the moment, we suggest this maxim is useful for all media commentary by researchers about their research.

I am worried that science may end up overpromising on what can be delivered in response to coronavirus disease 2019 (COVID-19). This isn’t because I think the scientific community has bad intentions or will purposefully overhype anything, but because of what science can report in real time. It is difficult to share progress with adequate caveats about how long things might take or whether they will work at all. The scientific method is a very deliberate process that has been honed over time: Basic research, which describes the problem, is followed by applied research that builds on that understanding. Now, scientists are trying to do both at the same time. This is not just fixing a plane while it’s flying—it’s fixing a plane that’s flying while its blueprints are still being drawn.
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On the testing side, polymerase chain reaction (PCR) technology is allowing folks to know quickly whether they are infected with SARS coronavirus 2 (SARS-CoV-2), the cause of COVID-19. However, a negative PCR test result may lead a person to erroneously conclude that they’re in the clear, which is a danger to controlling the spread. We urgently need serology tests that show whether someone has had the infection and recovered. And we must be able to identify individuals who have some immunity to SARS-CoV-2 because understanding their biology may contribute to helping the world recover.
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(Australia) Medical journal fast-tracks free publication of COVID-19 research – ResearchProfessionalNews (Rosslyn Beeby | April 2020)0

Posted by Admin in on April 26, 2020
 

Rapid review ‘risks errors, but being too slow with information sharing is a bigger risk’

We’re seeing two encouraging signs from the COVID-19 pandemic: a marvellous sense of cooperation between researchers from around the globe; and greater respect of the analysis and warnings from researchers.  But as we’ve noted recently, there is a concern about the rush to publish and the risk of dangerous mistakes.

Australia’s leading peer-reviewed medical journal has launched a rapid online publication process for COVID-19 research papers and is providing free public access to these studies.
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The Medical Journal of Australia has introduced the changes so that “the newest data and viewpoints are released as soon as possible”.
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Nicholas Talley, the journal’s editor-in-chief, said the MJA had “stepped up to do its part in the crisis” by developing an ultra-rapid review of papers submitted to the journal.
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The preprint papers are published on the MJA website in a section called Online First.

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(US) Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data – STAT (Lev Facher | February 2020)0

Posted by Admin in on April 24, 2020
 

The degree to which the results of clinical trials are not reported – especially when the expected results aren’t found – is a serious problem.  It’s inefficient, because down the road another researcher may seek to do the same test, not realising that it has already been unsuccessfully tested.  It is dangerous, because researchers and clinicians may expose patients to an agent because they don’t know about the failure.

WASHINGTON — For years, government research agencies have misinterpreted a law that requires them to collect and post clinical trial data, a federal judge ruled this week, leaving behind a 10-year gap in data that now must be made publicly available.
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Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs — meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data.
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The ruling, from a federal judge in New York’s Southern District, puts sponsors of clinical trials during that span out of compliance if they have not posted results to the government repository ClinicalTrials.Gov.
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“This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” said Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic who represented the plaintiffs. The ruling, he said, “makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavorable trial results secret.”
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Friday afternoon’s funny – Violation or deviation?0

Posted by Admin in on April 24, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

I’ve skipped the Friday arvo funnies for a few weeks, because they felt disrespectful, but a user of the AHRECS site pointed our this is exactly the time when we need a non-pandemic chuckle.

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