Chen SC, Sinaii N, Bedarida G, Gregorio MA, Emanuel E, Grady C.
Clinical Trial, October 2017
Healthy volunteers in phase 1 clinical trials contribute to the development of safe drugs and other biologics and accept risks and burdens without anticipated health benefits from participation. Although emerging data have shown that healthy volunteers are influenced by risk, some still worry that financial incentives lead them to take on unreasonable risk. Yet little is known about healthy volunteers' preferences and how they make choices about enrolling in research studies.
We surveyed 654 healthy volunteers at the end of their participation in a phase 1 Pfizer trial in the United States, Belgium, and Singapore to examine their reported willingness to enroll in studies of different types, with various procedures, and with possible side-effects.
The majority of respondents were willing to join many kinds of studies, but fewer were willing to participate in first-in-human vaccine studies or studies of psychiatric drugs than in other study types. With regard to procedures, a substantial proportion were unwilling to participate in studies that involved invasive procedures, such as a lumbar puncture (45.4%) and bone marrow biopsy (42.3%), but willing to participate in studies with less invasive procedures such as a computed tomography scan of the heart (86.8%), magnetic resonance imaging (87.4%), and skin allergy testing (86.8%). Although there was some variation by gender and region, the majority were willing to participate in studies with side-effects like pain (80%) or nausea and vomiting (64%), but only a minority were willing to join if the research drug would result in their having a one in a million chance of death (34.4%), a small chance of kidney damage (16.7%), or influence how their mind works (23.2%; Figure 4).
Our results suggest that healthy volunteers are willing to participate in a wide range of types of phase 1 clinical trials, and express preferences for low risk and familiar studies and study procedures, preferences which are partially affected by offers of payment.
Persad GC, Emanuel EJ.
Hastings Center Report, September 2017.
When Dr. Hortense screens her patients in Chicago for cervical dysplasia and cancer, she conducts a pelvic exam, takes a sample of cervical cells, and sends them for Pap cytology and human papilloma virus DNA co-testing. But when she conducts cervical cancer screening in Botswana, she employs a much simpler diagnostic strategy. She applies acetic acid to highlight precancerous lesions and visually inspects the cervix-a technique known as the VIA (visual inspection with acetic acid) method. She treats suspicious lesions with cryotherapy. There are multiple reasons that Dr. Hortense uses VIA in developing countries. It requires no specialized laboratory facilities or highly trained personnel. With immediate results, there is no delay in diagnosis and treatment, ensuring that patients are not lost to follow-up. Most importantly, VIA is considerably cheaper than Pap and HPV co-testing. This difference in care between Chicago and Botswana presents an ethical dilemma in global health: is it ethically acceptable to provide some patients cheaper treatments that are less effective or more toxic than the treatments other patients receive? We argue that it is ethical to consider local resource constraints when deciding what interventions to provide. The provision of cheaper, less effective health care is frequently the most effective way of promoting health and realizing the ethical values of utility, equality, and priority to the worst off.
Navathe AS, Song Z, Emanuel EJ.
JAMA, June 2017.
This Viewpoint discusses bundled payment models and suggests ways in which the next generation of episode-based payments can better align with population health.
Medical Journal of Australia, May 2017
We should aim at improving the care of dying patients
Modern debates about legalising euthanasia and physician-assisted suicide (PAS) in Great Britain and the United States began in the late 19th century.1Legislation was periodically proposed only to be defeated until, in 1942, Switzerland decriminalised assistance in suicide for cases when there were no “selfish motives”.2 In 2002, euthanasia was legalised in the Netherlands and Belgium, then in Luxembourg in 2009, and most recently, in 2015 in Colombia and in 2016 in Canada.3 PAS, but not euthanasia, has been legalised in five US states. In Oregon, PAS was legalised by popular referendum in 1997. In addition, in 2009, Washington State legalised PAS by referendum and Montana by court ruling; Vermont in 2013 and California in 2015 also legalised PAS by legislation.4