Clinical trials integrity: a CRO perspective

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.     

Empirically supported ethical research practice: the costs and benefits of research from the participants' view

Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

论美与数学

"美”与"数学”似乎是相隔遥远的两个领域.美现实而单纯,数学抽象而复杂.数学美正是本文要诠释的观点.     

The influence of religious and ethnic differences on marital intimacy: intermarriage versus intramarriage

The influence of religious and ethnic differences on marital intimacy was examined by administering the Personal Assessment of Intimacy in Relationships and a demographic/attitudinal questionnaire to 25 Jewish couples (intramarried) and 25 couples with one Jewish partner (intermarried). All couples were childless and in the first 5 years of their first marriage. Results indicated that the groups did not differ regarding couple level of intimacy, similarity of intimate experience, or mutual understanding. However, in-depth interviews revealed differences in the pathways by which these two groups arrived at a similar level of intimacy. Intramarried couples appear to experience greater personal similarity and mutual understanding rooted in their ethnic bond, which aids the development of intimacy. Intermarried couples appear to find that the very process of negotiating ethnic differences leads to greater mutual understanding and intimacy. These findings indicate that clinicians and religious leaders should not assume that intermarriage constrains levels of intimacy. Nor should it be assumed that intramarriage assures high intimacy.     

Facilitating a multidisciplinary parent support & education group guided by Allen's developmental health nursing model

Parents are generally the primary source of support and nurturing for children experiencing an eating disorder; yet, they often feel blamed for the illness. Guided by the developmental health model, the group focused on parents' competence and helped them share solutions; reframed situations related to development in adolescence and mid-life; and shifted the emphasis to process to help parents understand behaviors. Parents became partners in helping their children recover by sharing solutions and creating learning opportunities from adversity.     

A randomized trial of emotion-focused therapy for couples in a training clinic

Forty married couples participated in a randomized trial comparing 8 weekly sessions of emotion-focused therapy (EFT) for couples to a group of couples who were placed on an 8-week waiting list. A composite marital satisfaction score was created from scores on the Dyadic Adjustment Scale, Positive Feelings Questionnaire, and Personal Assessment of Intimacy in Relationships scale. Controlling for pretest scores, participants in the treatment group had significantly higher levels of marital satisfaction after 8 weeks than wait-list participants. Supplementary analyses identified variables associated with gains in therapy and with dropping out of the study.     

Health maintenance behaviors of individuals with severe and persistent mental illness in a state prison

The purpose of this grounded theory study is to define health and health-seeking behaviors of incarcerated individuals experiencing severe and persistent mental illness (SPMI) in a state prison. The strategies used to prevent loss of control and maintain health in the prison environment were examined. Nineteen incarcerated individuals with SPMI were interviewed in a state prison. Constant comparative analysis of the data revealed that while establishing a "fit" with the core variable "loss of control" and its identified properties, differences were found in the enactment of health maintenance behaviors related to properties in the prison environment. Several of these behaviors are inconsistent with behaviors expected of individuals in a community day treatment center and reflect a need for bridging programs to facilitate entry into the "free" world. Correctional nurses and mental health providers in this system can advocate for incarcerated individuals with SPMI by developing programs that provide cost-effective intermediate care and collaborating with community health systems for continuity of care. The findings related to alcohol and drug abuse among incarcerated individuals with SPMI challenges mental health providers in both correctional facilities and community-based programs to generate appropriate and effective substance abuse treatment programs for these individuals.     

Marijuana use and depression

The primary goal of this study is to examine the association between marijuana use and adult depressive symptomatology. The key independent variables examined are age of marijuana initiation, frequency of current marijuana use, the use of other licit and illicit drugs, and whether marijuana was used to cope with problems. The relationships among these variables are assessed using data from the Young Men and Drugs Survey (n = 1,941), a nationally representative sample of men from the 1944-1954 birth cohort. Results show that early marijuana initiation appears to be weakly associated with increased depression in adulthood. This effect, however, is mediated by educational attainment, employment status, marital status, and other drug use, notably alcohol and tobacco use. Adult frequency of marijuana use is not significantly associated with increased depression in adulthood. Finally, marijuana users who use the drug to cope with problems are more depressed than those who do not use to cope with problems.