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This chapter discusses the two means of data collection (case record reviews and interviews); the description of study variables, predictors, and outcomes; and the response rate, the handling of missing data, and how the data were weighted to adjust for interview nonresponse.

This introductory chapter discusses the magistrates and their possible roles in debt, marriage, and land disputes. It begins with the data sources used by the author, namely the Qing official law, original case records, and the collections of judicial decisions. The latter part of the chapter introduces two fundamental issues, namely: the Qing approach to matters concerning land, debt, and marriage, and the multiple roles of the magistrate in terms of his responsibilities.

Chapter 5 of Practice Research in the Human Services: A University-Agency Partnership Model focuses on studies of child welfare practice in county human service agencies. An early multi-county project explored the tensions that arise in interprofessional relationships within the juvenile dependency system, using interviews and focus groups with legal and child welfare professionals, as well as foster youth and caregivers. A second project developed innovative qualitative data mining methods to examine an array of practice issues that included parental substance use, child trauma, and skillful social work practice with youth, using the case record documents created by child welfare workers as the data source. Practice research principles derived from the projects relate to the essential role of communications throughout the research process, the contrasting time frames that operate in agency and academic research settings, and the need for awareness of the potential for political sensitivity surrounding study findings.

The main objective is to help physicians carry out those aspects of clinical trials described in this book. . . .Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). . . . . . . —[ICH-GCP 2.8]. . . It is hardly rational to expect people to do things properly unless they are shown how, so that the importance of formal training and education for everyone involved with the pharmaceutical industry should be self-evident. The perpetuation of bad habits by those who are poorly trained and educated, whether in pharmaceutical companies or at investigator sites, is one of the root causes of the inefficiencies in drug development. Yet, while few people (whether or not they actually educate people properly) would dispute the importance of well-trained employees, it is uncommon for most companies to insist that all of those upon whom they depend are properly trained as well. Among those who are rarely trained to meet the required standards of excellence are CRO staff and investigators and their site staff. Negotiations with CROs rarely involve an assessment of how the various tasks are performed and whether or not they are carried out to the standards expected by the sponsor staff. This is not to imply that sponsor employees are better at what they do than CRO staff. What is true, however, is that sponsor employees should know how to do things the way the sponsor wants them done, which in turn should correspond to the sponsor’s notion of excellence. CROs will always profess to have all the processes requested by a sponsor, so that a laissez-faire attitude pervades negotiations. However, CROs quite understandably have their own ways of working, and unless alternatives are specified contractually, what the CRO does is what the sponsor gets. The next logical step after specifying what is wanted is to provide the necessary training for CRO staff. Where education and training are most needed and are carried out most poorly is in the case of clinical trial investigators.

Clinical trial processes are what we repeatedly do in clinical research, but, unfortunately, the habit of excellence is not as prevalent as it might be. Processes are only as good as the ways in which they are carried out, so this aspect is worth looking at before examining the processes themselves. Excellence means the very best that is achievable in a given situation with the knowledge and resources available, and it is not to be confused with perfection, which is rarely attainable, and trying to achieve it is a waste of time. Although the rational implementation of the various approaches described later can help to make the clinical development process significantly more efficient, this will not in itself achieve excellence. Implementation needs to take place in a cultural, intellectual, and operational environment that lends the necessary support. There are many possible components of such an environment, but one can go far by • instituting some basic behavioral elements; • doing things as well as they can be done all the time; • simplifying processes; • not allowing regulations to develop into liabilities. I have included this section risking that it might be considered unnecessary and patronizing by some. After all, everybody believes that their behavior is impeccable, just as everybody is a perfect driver. It only takes a few people to behave badly to poison an organization (or to injure others). . . . Laws control the lesser man. Right conduct controls the greater one. . . . . . .—Chinese proverb. . . . . .Good behavior is the last refuge of mediocrity.. . . . . . —Henry S. Haskins, stockbroker who was expelled for alleged misconduct and published his aphorisms anonymously. . . Can principles be applied that encourage positive, ethical, complex, and intelligent behavior without retreating into the lowest common denominator of mediocrity? One can argue the extent to which principles can help to achieve these objectives, but what is undeniable is that, in their absence, the results can be extremely damaging. This is exemplified not only by the poor performance metrics but also by the poor reputation of the pharmaceutical industry in the public’s view.