Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician's conscience, or that the trial will impose excessive burdens on the clinician.

Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials.

Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.

Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations.

Pragmatic clinical trials are increasingly used to generate knowledge about real-world clinical interventions. However, they involve some distinctive ethical and regulatory challenges. In this article, we examine a set of issues related to incentives and other payments to patients in pragmatic clinical trials. Although many of the ethical concerns related to incentives and payments in explanatory trials pertain to pragmatic clinical trials, the pragmatic features may introduce additional challenges. These include those related to the risk of incentives and payments undermining the scientific validity and social value of pragmatic clinical trials, the sources of data used in pragmatic clinical trials, and when the pragmatic clinical trials are conducted under waivers of consent. Based on our examination of these matters, we offer some preliminary recommendations regarding incentives and payments in pragmatic clinical trials, recognizing that additional data and experiences are needed to refine them.

The pattern of breast cancer screening utilization and its consequences.

BACKGROUND: The objective of this study was to describe the pattern of screening utilization and its consequences in terms of tumor size and time of tumor appearance of invasive breast carcinoma among a population of women who were examined at a large service screening/diagnostic program over the last decade. METHODS: Utilization of mammography was assessed from a population of 59,899 women who received 196,891 mammograms at the Massachusetts General Hospital Breast Imaging Division from January 1, 1990 to March 1, 1999, among which 604 invasive breast tumors were found. Two hundred six invasive, clinically detected tumors also were seen during this period among women who had no record of a previous mammogram. Additional information was available on screening of women from March 1, 1999 to June 1, 2001. RESULTS: Fifty percent of the women who used screening did not begin until the age of 50 years, although 25% of the invasive breast tumors were found in women age < 50 years. Relatively few of the women who used screening returned promptly for their annual examinations; by 1.5 years, only 50% had returned. Approximately 25% of the invasive breast tumors were found in women for whom there was no record of a previous screening mammogram, and these tumors were larger (median, 15 mm) than the screen-detected tumors (median, 10 mm). Approximately 30% of the 604 invasive breast tumors in the screening population were found on nonmammographic grounds, and they also were larger (median, 15 mm) than the screen-detected tumors (median, 10 mm). However, only 3% of these 604 tumors were found by nonmammographic criteria within 6 months of the previous negative examination, and only 12% were found within 1 year. By back calculating the likely size of each of these tumors at the time of the negative mammogram, it could be seen that most tumors probably emerged as larger, palpable masses not because they were missed at the previous negative mammogram, because most were too small then to have been detected, but because too much time had been allowed to pass. CONCLUSIONS: Far too many women did not comply with the American Cancer Society recommendation of prompt annual screening from the age of 40 years. Consequently, almost 50% of the invasive tumors emerged as larger and, thus, potentially more lethal, palpable masses.