Paid protection? Ethics of incentivised long-acting reversible contraception in adolescents with alcohol and other drug use

Journal of Medical Ethics 2017;43:182-187.
Authors: Won T, Blumenthal-Barby J, Chacko M
“Pregnant adolescents have a higher risk of poor maternal and fetal outcomes, particularly in the setting of concomitant maternal alcohol and other drug (AOD) use. Despite numerous programmes aimed at reducing overall teen pregnancy rates and the recognition of AOD use as a risk factor for unintended pregnancy in adolescents, interventions targeting this specific group have been sparse. In adult drug-using women, financial incentives for contraception have been provided but are ethically controversial. This article explores whether a trial could ethically employ monetary incentives in adolescents with AOD use to promote the use of long-acting reversible contraception (LARC), with special attention to the relevant distinctions between adults and adolescents.”
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Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

BMJ 2017; 356:i6770
Authors: Rosa Ahn, Alexandra Woodbridge, Ann Abraham, Susan Saba et al
“Randomized controlled trials (RCTs) are considered the most reliable form of evidence in evaluating the safety and efficacy of drugs. Because results of RCTs shape the evidence base, objectivity in the conduct of clinical trials has important implications for clinical practice and the health and safety of patients. However, critics worry that involvement of the pharmaceutical industry may bias the design and interpretation of RCTs.”
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Randomised placebo-controlled trials of surgery: ethical analysis and guidelines

J Med Ethics 2016; 42:776-783
Authors: Julian Savulescu, Karolina Wartolowska, Andy Carr
“Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: (1) the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; (2) clinically important research question; (3) the risk to patients is minimised and reasonable; (4) there is uncertainty about treatment allocation rather than deception; (5) there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and (6) ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool.”
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Therapeutic appropriation: a new concept in the ethics of clinical research

J Med Ethics 2016; 42:805-808
Authors: Rosalind McDougall, Dominique Martin, Lynn Gillam, Nina Hallowell, Alison Brookes, Marilys Guillemin
“In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients’ clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds.”
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An analysis of common ethical justifications for compassionate use programs for experimental drugs

BMC Medical Ethics 2016 17:60
Author: Kasper Raus
“When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs.”
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Unreported trials a betrayal of patients

MJA Insight, 14 November 2016
Author: Jane McCredie
“Not all journal editors have rigorously enforced the “no-registration-means-no-publication” policy. Around half of the responding editors said that they did not require registration, two-thirds said that they would accept retrospectively registered trials (completely defeating the purpose), and a meagre 18% bothered cross-checking submitted papers against the details in the original registration.”
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Permitting patients to pay for participation in clinical trials: the advent of the P4 trial

Med Health Care and Philos (2016). doi:10.1007/s11019-016-9741-2
Authors: David Shaw, Guido de Wert, Wybo Dondorp, David Townend, Gerard Bos, Michel van Gelder
“In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.”
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An analysis of common ethical justifications for compassionate use programs for experimental drugs

BMC Medical Ethics 2016 17:60
Author: Kasper Raus
“Currently, there are ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs.”
Find article here.