A Sitting Duck: Local Government Regulation of Hunting and Weapons Discharge in the State of New York

On March 31, 2014, the New York State Legislature significantly modified New York\u27s Environmental Conservation Law. The Environmental Conservation Law imposes limitations on the discharge of longbows. A longbow is defined by New York\u27s Department of Environmental Conservation as “a longbow, recurve bow or compound bow which is designed to be used by holding the bow at arm\u27s length, with arrow on the string, and which is drawn, pulled and released by hand or with the aid of a hand-held trigger device attached to the bowstring.” Before the 2014 amendment, longbows could not be discharged in such a way that an arrow passes over a road or within 500 feet of a dwelling, except with the consent of the owner of such dwelling. The 2014 amendment reduced this 500-foot setback to 150 feet, making New York\u27s rule generally consistent with that of neighboring states. This is a radical difference: a circle with a 500 foot radius has an area of slightly over 18 acres while a circle with a 150 foot radius has an area of slightly over 1.6 acres

Challenging Assumptions About Minority Participation in US Clinical Research

Although extensive research addresses minorities’ low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities’ participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities’ distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field

Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time

Background Increasing the diversity of research participants is an important focus of clinical trials. However, little is known regarding who enrolls as healthy volunteers in Phase I clinical trials, which test the safety and tolerability of investigational new drugs. Despite the risk, healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling. Objective This study’s purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials. Methods The HealthyVOICES Project (HVP) is a longitudinal study of healthy individuals who have enrolled in Phase I trials. We describe self-reported sociodemographic information and Phase I trial history from HVP recruitment (May-December 2013) through the project’s end three years later (December 2016). Trial experiences are presented as medians and quartiles. Results The HVP included 178 participants. Nearly three-fourths of participants were male, and two-thirds were classified as racial and ethnic minorities. We found that some groups of participants were more likely to have completed a greater number of clinical trials over a longer timeframe than others. Those groups included participants who were male, Black, Hispanic, 30-39-years-old, unemployed, had received vocational training in a trade, or had annual household incomes of less than $25,000. Additionally, the greater the number of clinical trials participants had completed, the more likely they were to continue screening for new trials over the course of three years. Participants who pursued clinical trials as a full-time job participated in the greatest number of trials and were the most likely to continuing screening over time. Implications Participation as a healthy volunteer in US Phase I trials is driven by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and participate longer than more privileged groups

Burden Estimates, Post-diagnosis Care, and Outcomes Associated with Peripheral Artery Disease in the Atherosclerosis Risk in Communities Study

Peripheral artery disease (PAD) is a progressive atherosclerotic disorder of the lower extremities that causes adverse individual- and health care system-level consequences as populations age. This doctoral dissertation research estimated the annual period prevalence and incidence of PAD as well as the frequency of care and mortality following diagnosis in the outpatient or inpatient setting. The majority (>70%) of all PAD encounters occurred in the outpatient setting. The weighted mean age-standardized prevalence and incidence of outpatient PAD was 11.8% (95% CI: 11.5, 12.1) and 22.4 (95% CI: 20.8, 24.0) per 1000 person-years, respectively. Blacks had a higher mean weighted mean age-standardized prevalence (15.6%; 95% CI: 14.6, 16.4) as compared to whites (11.4%; 95% CI: 11.1, 11.7). Blacks also had a higher incidence rate of PAD (31.3 per 1000 person-years; 95% CI: 27.3, 35.4) as compared to whites (25.4 per 1000 person-years; 95% CI: 23.5, 27.3). PAD prevalence and incidence did not differ by gender alone. One-thousand eighty six incident cases of PAD were identified from 2002-2010. PAD-related post-diagnosis encounters were 2.15 (95% CI: 2.10, 2.21) and 1.02 (95% CI: 0.94, 1.10) among those with an incident PAD diagnosis in the outpatient and inpatient setting, respectively. Participants with PAD had an average of 6-8 primary care encounters per person-year over the course of our study. PAD-related and all-cause hospitalization was 6.4% (95% CI: 4.8, 8.1) and 32.2% (95% CI: 29.0, 35.2) at one year among those with incident outpatient PAD. Approximately 14% (95% CI: 9.3, 18.7) of participants diagnosed with inpatient PAD had a PAD-related rehospitalization at one year while 43.4% (95% CI: 36.3, 49.7) had an all-cause rehospitalization at one year. One year age-standardized case fatality was 7.1% (95% CI: 5.4, 8.7) and 16.0% (95% CI: 11.0, 21.1) among those diagnosed in the outpatient and inpatient setting, respectively. Peripheral artery disease and utilization of outpatient health care services was common among men and women 65 years of age and older with enrollment in a Medicare fee-for-service program sampled of four US communities.Doctor of Philosoph

Altruism in clinical research: Coordinators’ orientation to their professional roles

Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus re-shaping their professional identities

United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study

There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities

Peering into the pharmaceutical “pipeline”: Investigational drugs, clinical trials, and industry priorities

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered

Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?

Background/aims Financial compensation for research participation is a major focus of ethical concern regarding human subject recruitment. Phase I trials are sometimes considered to be a lucrative source of income for healthy volunteers, encouraging some people to become "professional guinea pigs." Yet, little is known about how much these clinical trials actually pay and how much healthy volunteers earn from them. Methods As part of a mixed-methods, longitudinal study of healthy volunteers, we required participants to complete clinical trial diaries, or surveys that captured detailed information about screening and enrollment in Phase I trials. Over a 3-year period, participants provided information online or via telephone about each clinical trial for which they screened (e.g. the clinic name, the study's therapeutic area, the length of the trial, the number of nights spent in the clinic, and the study compensation), and whether they qualified for trial inclusion. Clinical trial diaries generated data about whether participants continued to screen for and enroll in clinical trials and how much money they earned from their participation. Results 131 participants routinely completed clinical trial diaries or confirmed that they had not screened for any new clinical trials. Together, these participants screened for 1001 clinical trials at 73 research facilities during a 3-year period. Overall, the median clinical trial compensation was US$3070 (range=US$150-US$13,000). Participants seeking new healthy volunteer trials tended to screen for three studies per year, participate in one or two studies, and earn roughly US$4000 annually. Participants who were unemployed earned the most income from clinical trials compared to those with full-time or part-time jobs, and those individuals whom we label "occupational" participants because of their persistent pursuit of clinical trials earned more than people who screened occasionally. Notably, the median annual trial compensation was well below US$10,000 for all employment groups, and most occupational healthy volunteers also earned less than US$10,000 each year. The 10% of participants who earned the most had a median annual income of US$18,885 from clinical trials, and there was significant volatility in these individuals' earnings from year to year. Conclusion Despite the perception that Phase I enrollment can generate significant earnings, it was exceedingly rare for anyone in this study to make more than US$20,000 in a single year, and unusual to earn even between US$10,000 and US$20,000. From an ethics perspective, individual trials might appear to unduly induce enrollment by offering significant sums of money, but given our findings, the larger problem for low-income participants may be the unrealistic perception that clinical trials alone could be a way of earning a living

Peripheral Artery Disease Prevalence and Incidence Estimated From Both Outpatient and Inpatient Settings Among Medicare Fee‐for‐Service Beneficiaries in the Atherosclerosis Risk in Communities (ARIC) Study

BACKGROUND: Outpatient ascertainment of peripheral artery disease (PAD) is rarely considered in the measurement of PAD clinical burden; therefore, the clinical burden of PAD likely has been underestimated while contributing to a decreased awareness of PAD in comparison to other circulatory system disorders. METHODS AND RESULTS: The purpose of this study was to estimate the age-standardized annual period prevalence and incidence of PAD in the outpatient and inpatient settings using data from the Atherosclerosis Risk in Communities (ARIC) study linked with Centers for Medicare and Medicaid Services claims. The majority (>70%) of all PAD encounters occurred in the outpatient setting. The weighted mean age-standardized prevalence and incidence of outpatient PAD was 11.8% (95% CI 11.5-12.1) and 22.4 per 1000 person-years (95% CI 20.8-24.0), respectively. Black patients had higher weighted mean age-standardized prevalence (15.6%; 95% CI 14.6-16.4) compared with white patients (11.4%; 95% CI 11.1-11.7). Black women had the highest weighted mean age-standardized prevalence (16.9%; 95% CI 16.0-17.8). Black patients also had a higher incidence rate of PAD (31.3 per 1000 person-years; 95% CI 27.3-35.4) compared with white patients (25.4 per 1000 person-years; 95% CI 23.5-27.3). PAD prevalence and incidence did not differ by sex alone. CONCLUSIONS: This study provides comprehensive estimates of PAD in the inpatient and outpatient settings where the majority of PAD burden was found. PAD is an important circulatory system disorder similar in prevalence to stroke and coronary heart disease