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

An Argument for Fewer Clinical Trials (Papers: Kirstin Borgerson 2016)0

Posted by Admin in on December 11, 2016
 

Abstract

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I consider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible.

The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.

Borgerson K (2016) “An Argument for Fewer Clinical Trials,” Hastings Center Report 46 1–11. DOI: 10.1002/hast.637
Publisher: http://onlinelibrary.wiley.com/doi/10.1002/hast.637/full

Industry sponsorship and research outcome (Papers: Andreas Lundh, et al 2012)0

Posted by Admin in on December 10, 2016
 

Abstract

Background

Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor’s product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also investigating sponsorship of device studies.

Objectives

To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship.

Search methods

We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). In addition, we searched reference lists of included papers, previous systematic reviews and author files.

Selection criteria

Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions.
Data collection and analysis

Two assessors identified potentially relevant papers, and a decision about final inclusion was made by all authors. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals).

Main results

Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.32 (95% confidence interval (CI): 1.21 to 1.44), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120 device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.84 (95% CI: 0.70 to 1.01).

Authors’ conclusions

Sponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard ‘Risk of bias’ assessments.

Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L (2012) Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews. Number 12 DOI: 10.1002/14651858.MR000033.pub2
Publisher: http://onlinelibrary.wiley.com/doi/10.1002/14651858.MR000033.pub2/abstract

He Tangata Kei Tua Guidelines for Biobanking with Māori0

Posted by Admin in on December 6, 2016
 

Kei tua o te awe māpara he tangata kē, he mā?

Introduction

Māori ethical frameworks recognise that all research in New Zealand is of interest to Māori and outline community expectations of appropriate behavior in research to deliver the best outcomes for Māori. Research contributes to the broader development objectives of society and this endeavor is being supported by biobanking infrastructure. Ethics has a specific role in guiding key behaviours, processes and methodologies used in research. This document outlines a framework for addressing Māori ethical issues within the context of biobanking. It draws on a foundation of mātauranga (Indigenous knowledge) and tikanga Māori (Māori protocols and practices) and will be useful for researchers, ethics committee members and those who engage in consultation or advice about biobanking with Māori in local, regional, national or international settings.

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On the Origins of Research Ethics: China and the West – Bioethics.net Blog (Craig Klugman, Ph.D July 2015)0

Posted by Admin in on December 4, 2016
 

When I was a graduate student, I was fortunate to be one of five students chosen by the China Medical Board to attend an international bioethics conference between the U.S. and China in Beijing. We listened to talks on the philosophical bases of ethics in each country and culture. The U.S. laid its philosophical history on the doorsteps of the ancient Greek traditions such as Plato and Aristotle as well as later European thinkers such as Kant, Mill, and Bentham. The Chinese delegates talked of Confucius and Lao Tzu. We toured a hospital and a medical school. I still have a black plastic plate with the image of the medical college drawn in a gold color that was a gift to us guests.

I was assigned to a break out session where both countries were supposed to talk about values of medical ethics in the hopes of crafting an international and intercultural code of medical ethics. As a graduate student I asked the too-wise-for-my-britches question, “How can we create an international code of ethics when we are only two countries?” I was quickly quieted as the chair, an illustrious scholar, said, “Privacy. We can agree that privacy is important, correct.” There was a lot of chatter and head nodding. Another American student sitting next to me, whispered in my ear, “I don’t know all of what they said in Chinese, but the last part was, ‘Don’t translate this for the Americans’.” The interpreter then said out loud, “Yes, we can agree to privacy.”

Two days later at the closing ceremony, a written document was placed before the head of each delegation. A list of agreed upon values and ideas was read to the audience. A pen was handed to each leader. The Chinese leader stopped and after a brief statement, the interpreter said, “We cannot sign this. We do not agree with it.” What had been lost in cultural translation was that in China, one does not contradict a guest and we were the guests.

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