Rules on reporting trials must be better enforced, say health integrity groups

BMJ 2017; 359: j5786
Author: Deborah Cohen
“Unregulated reporting of clinical trials opens the door to fraud and corruption, undermining medical advances and public health objectives, a report has warned. The report, by a consortium of “health integrity organisations,” urges governments to enforce current rules to ensure that patients, doctors, and scientists can access the full results of all clinical trials.”
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Designing Ethical Trials of Germline Gene Editing

N Engl J Med 2017; 377:1911-1913
Author: Bryan Cwik
“Much of the biomedical ethics literature on gene editing has focused on broad social issues related to how it should be done, such as questions about using it for enhancing human cognitive abilities. Comparatively little has dealt with more ground-floor ethical issues about the design of clinical trials and use of gene editing in reproductive medicine. The time for that discussion has now come: foreseeable use of gene editing in reproductive medicine is no longer science fiction, and it’s important to consider seriously what would be required for the conduct of ethically sound clinical trials of this new technology.”
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Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

JAMA Intern Med. 2017; 177(10): 1-8.
Authors: Peter Doshi, Peter Hur, Mark Jones, et al
“Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.”
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Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting

BMC Medical Ethics 2017 18:36
Authors: J. Lawton, N. Hallowell, C. Snowdon, J. E. Norman, K. Carruthers, F. C. Denison
“Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention.”
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The Ethics of Clinical Trials Research in Severe Mood Disorders

Bioethics. May 2017. doi:10.1111/bioe.12349
Authors: Nugent, A. C., Miller, F. G., Henter, I. D. and Zarate, C. A.
“Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research.”
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How Do We Protect Patients From False Promises In Right-To-Try Laws?

Health Affairs Blog, 14 March 2017
Author: Ellen Sigal
“Unfortunately, the current federal legislation provides almost no protections for patients. Everyone with a late-stage terminal illness like my sister deserves the chance to try an experimental therapy. However, serious changes to today’s legislative proposal are needed before this law is safe for patients.”
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Patients Demand The ‘Right To Try’ Experimental Drugs, But Costs Can Be Steep

NPR, 3 March 2017
Author: Carrie Feibel
“In the last three years, 33 U.S. states have passed laws aimed at helping dying people get easier access to experimental treatments that are still in the early stages of human testing. Supporters say these patients are just looking for the right to try these treatments. Such laws sound compassionate, but medical ethicists warn they pose worrisome risks to the health and finances of vulnerable patients.”
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How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

JME Blog, 20 February 2017
Author: Nir Eyal
“While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials? If we cannot, we might need to give up on the hope of curing HIV, or of achieving controlled remission.”
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A Call For The FDA To Raise The Bar For Clinical Trials Is Flawed

Forbes, 22 February 2017
Author: John LaMattina
“As the new Trump administration begins to take shape, there are concerns that new leadership at the FDA will call for less bureaucracy and red tape, thereby lowering the bar for new drug approvals. The view is that onerous regulations are preventing life-saving medications from getting to those who most need them. Lowering the standards for drug approvals may indeed allow for earlier patient access to drugs but, as has been discussed here in the past, liberalization of current regulations would be a mistake. Such actions will unleash drugs that will ultimately prove to be ineffective and, in some cases, harmful rather than beneficial.”
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