The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under controlled, in-patient conditions using healthy … Read more

This paper introduces the term “structural coercion” to underscore the ways in which broader social, economic, and political contexts act upon individuals to compel them to enroll as subjects in clinical research. The paper challenges the adequacy of the concepts of “coercion” and “undue influence” in determining when research participation is voluntary. Acknowledging structural coercion … Read more

Aggregate data about pharmaceutical research and development (R&D) tend to examine Phase III trials. Hence, there are few published data about investigational drugs in earlier phases of clinical development that might fail. It is also unclear how well R&D corresponds to disease burden. We track the pharmaceutical pipeline using data from industry publications that provide … Read more

OBJECTIVE: The purpose of the research was to assess real-time location systems (RTLS) that have been implemented in U.S. hospitals. We examined the type of uses to which RTLS have been put, the degree of functionality of the various technologies and software, and the organizational effects of implementing RTLS. METHODS: The project was a 3-year … Read more

OBJECTIVE: Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus reshaping their professional identities. The purpose of this study was to identify how research coordinators manage role and ethical conflicts within clinical research trials. METHODS: A qualitative study combining observation and 63 semistructured … Read more

Establishing contacts and gaining permission to conduct ethnographic or qualitative research can be time-consuming and stressful processes. Gaining access can be especially challenging when representatives of prospective research sites see their work as being sensitive and would prefer to avoid outside scrutiny altogether. One result of this dynamic is that many organizations that exert a … Read more

How does contemporary science contribute to our understanding about what it means to be women or men? What are the social implications of scientific claims about differences between “male” and “female” brains, hormones, and genes? How does culture influence scientific and medical research and its findings about human sexuality, especially so-called normal and deviant desires … Read more

We systematically reviewed evidence on adjuvant treatment of phenylketonuria (PKU) and evidence for a target phenylalanine (Phe) level to minimize cognitive impairment., We searched MEDLINE, PsycINFO, Embase Drugs and Pharmacology, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), the National Agricultural Library (AGRICOLA), and the reference lists of included studies. We searched the … Read more