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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Dying Scientist and his Rogue Vaccine Trial – Wired (Amanda Schaffer | May 2018)0

Posted by Admin in on June 18, 2018
 

Bill Halford was convinced he’d found a miracle cure, but he was running out of time to prove it. So he teamed up with a Hollywood executive and recruited a band of desperate patients.

IN A PHOTO from 2009, Bill Halford, who was then 40 years old, looks like a schoolboy who hasn’t quite grown into his big ears. He wears an ill-fitting red shirt tucked into belted khakis; his jawline is square and his eyes are full of wonder. The picture was taken at Southern Illinois University, where he was a respected professor. A few years before, he had made a significant discovery—one that would determine the course of his life.

Halford, a microbiologist, had taken an interest in the peculiar nature of herpes—how it lies dormant in the nervous system and reactivates to cause disease. Herpes is one of the most pervasive viral infections in the world, sometimes causing painful genital blisters, and it has frustrated scientists attempting to find a cure. But in 2007, Halford realized that a weakened form of the virus he’d been studying might serve as a vaccine. He designed an experiment in which he inoculated mice with this variant, then exposed them to the wild-type form of the virus. In 2011 he published the results: Virtually all the mice survived. By contrast, animals that were not injected with his vaccine died in large numbers. It was promising science.

That same year, however, Halford became seriously ill. At first he thought he had a sinus infection, but it turned out to be a rare and aggressive form of cancer, sinonasal undifferentiated carcinoma. Halford was 42 years old at the time, with two teenage children. He underwent chemotherapy and radiation followed by surgery, but he was told that the form of cancer he had did not usually stay at bay for long. Halford had always been determined—“a 90-hours-a-week sort of researcher,” as his wife, Melanie Halford, puts it. The cancer diagnosis only seemed to harden his focus. Others had tried, and failed, to develop a herpes vaccine, but Halford was convinced that his method—using a live, attenuated form of the virus—would succeed. He would use whatever time he had left to show he was right.

Read the rest of this discussion piece

Colin Thomson recognised in this week’s Queen’s Birthday Honours List0

Posted by Admin in on June 11, 2018
 

AHRECS is very proud to acknowledge the achievements of one of our senior consultants, Prof. Colin Thomson. Colin was recognised in this week’s Queen’s Birthday Honours List.

Colin is held in the highest regard by colleagues across the research ethics sector in Australia for his key contributions to the development of sensible and responsive regulation and workable research ethics guidance in this country. His best-known roles have been as chair of the Australian Health Ethics Committee and as a key drafter of the 2007 National Statement on Ethics Conduct in Human Research. As a result, he has been asked to chair a wide range of university, health, Federal and State government and research agency research ethics committees. In some cases, he played a critical role as the first chair of the committee creating ways for working that modelled best practice for the research sector. In some instances, he has been invited to share his expertise internationally.

As a result, relationships between researchers, reviewers and regulators in Australia are far healthier than in most other parts of the world. Unusually in a sector where people sometimes gauge their own worth against the research achievements of others and also where we have traced the emergence of an adversarial culture, there is deep personal affection for Colin among many researchers, reviewers and regulators. He has continued to mentor new generations of researchers, reviewers and ethics managers.

Colin models a commitment to public service and acts with a generosity of spirit that encourages others to engage with ethics. He never seeks to push other people out of the way but also never shrinks from playing a leadership role when that has been necessary. He looks to learn something from every role that he takes and is happy to share this with colleagues of every level and, indeed, reflect on the limitations of his understanding.

AHRECS cannot think of a better colleague.

Why all randomised controlled trials produce biased results (Papers: Alexander Krauss | March 2018)0

Posted by Admin in on June 7, 2018
 

Abstract

Background: Randomised controlled trials (RCTs) are commonly viewed as the best research method to inform public health and social policy. Usually they are thought of as providing the most rigorous evidence of a treatment’s effectiveness without strong assumptions, biases and limitations.

Objective: This is the first study to examine that hypothesis by assessing the 10 most cited RCT studies worldwide.

Data sources: These 10 RCT studies with the highest number of citations in any journal (up to June 2016) were identified by searching Scopus (the largest database of peer-reviewed journals).

Results: This study shows that these world-leading RCTs that have influenced policy produce biased results by illustrating that participants’ background traits that affect outcomes are often poorly distributed between trial groups, that the trials often neglect alternative factors contributing to their main reported outcome and, among many other issues, that the trials are often only partially blinded or unblinded. The study here also identifies a number of novel and important assumptions, biases and limitations not yet thoroughly discussed in existing studies that arise when designing, implementing and analysing trials.

Conclusions: Researchers and policymakers need to become better aware of the broader set of assumptions, biases and limitations in trials. Journals need to also begin requiring researchers to outline them in their studies. We need to furthermore better use RCTs together with other research methods.

Key messages

  • RCTs face a range of strong assumptions, biases and limitations that have not yet all been thoroughly discussed in the literature.
  • This study assesses the 10 most cited RCTs worldwide and shows that trials inevitably produce bias.
  • Trials involve complex processes – from randomising, blinding and controlling, to implementing treatments, monitoring participants etc. – that require many decisions and steps at different levels that bring their own assumptions and degree of bias to results.

Keywords: Randomised controlled trial, RCT, reproducibility crisis, replication crisis, bias, statistical bias, evidence-based medicine, evidence-based practice, reproducibility of results, clinical medicine, research design

Krauss, A. (2018) Why all randomised controlled trials produce biased results. Annals of Medicine. 50:4, 312-322, DOI: 10.1080/07853890.2018.1453233
Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/07853890.2018.1453233

PRO-RES PROJECT0

Posted by Admin in on May 23, 2018
 

AHRECS is delighted to have three of its senior consultants, Mark Israel, Gary Allen and Colin Thomson form part of the UK Academy of the Social Sciences team in an ambitious €2.8 million project involving 13 European scientific institutions. The PRO-RES project, coordinated by the European Science Foundation, is aiming to build a research ethics and integrity framework, covering all non-medical research fields. It seeks the same reach that the Oviedo and Helsinki frameworks have in the medical field.

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