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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – CISION (Osvaldo R. Martinez-Clark | November 2019)0

Posted by Admin in on November 28, 2019
 

This is the world’s first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world’s most expensive pay-to-play trial with a one million price tag to enroll.

This isn’t a human research ethics vignette/scenario, but could very easily be used as the basis for a discussion with researchers, research ethics reviewers, research ethics advisers, or research office staff about:
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  1. Pay-to-play clinical trials
  2. Appropriate recruitment materials
  3. The use of ethics approval as a sales tool
  4. The conduct of trials in another country

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ — Libella Gene Therapeutics, LLC (“Libella”) announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world’s only treatment to cure and reverse aging by 20 years.
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Under Libella’s pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.
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Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.
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Telomeres are the body’s biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.
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Examination of CIs in health and medical journals from 1976 to 2019: an observational study (Papers: Adrian Gerard Barnett, Jonathan D Wren | November 2019)0

Posted by Admin in on November 26, 2019
 

Abstract

Objectives
Previous research has shown clear biases in the distribution of published p values, with an excess below the 0.05 threshold due to a combination of p-hacking and publication bias. We aimed to examine the bias for statistical significance using published confidence intervals.

Design Observational study.

Setting
Papers published in Medline since 1976.

Participants
Over 968 000 confidence intervals extracted from abstracts and over 350 000 intervals extracted from the full-text.

Outcome measures
Cumulative distributions of lower and upper confidence interval limits for ratio estimates.

Results
We found an excess of statistically significant results with a glut of lower intervals just above one and upper intervals just below 1. These excesses have not improved in recent years. The excesses did not appear in a set of over 100 000 confidence intervals that were not subject to p-hacking or publication bias.

Conclusions
The huge excesses of published confidence intervals that are just below the statistically significant threshold are not statistically plausible. Large improvements in research practice are needed to provide more results that better reflect the truth.

Barnett, A.G., Wren, J.D. (2019)  Examination of CIs in health and medical journals from 1976 to 2019: an observational study. 

(Australia) Skin cancer doctor in hot water after papers retracted – The Age (Liam Mannix and Tom Cowie | November 2019)0

Posted by Admin in on November 24, 2019
 

For most, sailing the Mediterranean on a luxury cruise ship is a relaxing escape. But skin cancer expert Professor Anthony Dixon was working. And a storm was about to hit the credibility of his research.

Over the 12-day cruise, the professor spent nine hours teaching doctors and nurses how to recognise skin cancer. A prominent educator, Professor Dixon has trained dozens of health professionals in his methods, many of them on cruise ships.

But two of his journal articles were about to be retracted after complaints from other cancer experts that they contained factual errors. Such retractions are considered rare and necessary to prevent inaccurate information being available to other practitioners.

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23andMe, moving beyond consumer DNA tests, is building a clinical trial recruitment business – STAT (Rebecca Robbins | September 2019)0

Posted by Admin in on November 23, 2019
 

SAN FRANCISCO — Consumer genetics giant 23andMe announced Thursday that it would move deeper into the business of clinical trial recruitment, partnering with a fast-growing startup to help match its customers with nearby study sites based on their diseases, demographics, and DNA.

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This story touches on a tricky problem: The use for recruitment purposes of a service that people would have understood to be private and not for research purposes.

The Silicon Valley company has for months been quietly making inroads into clinical trial recruitment by emailing customers who’ve opted in with recommendations about studies that might be appropriate for them. It has recruited for studies, both interventional and observational, in disease areas including Alzheimer’s, Parkinson’s, attention-deficit hyperactivity disorder, eczema, and liver disease, a spokesperson for the company confirmed.
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But the new partnership with TrialSpark, which offers a tech-powered alternative to traditional contract research organizations, may help 23andMe address one of the biggest challenges in clinical trial recruitment: geography. The idea is that patients who want to enroll in a clinical trial centered out of, say, Memorial Sloan Kettering Cancer Center, won’t have to fly to New York and can instead participate by visiting their local doctor’s office.
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