Context Of Clinical Research Research Articles

Exploratory study of the feasibility and utility of the colored eco-genetic relationship map (CEGRM) in women at high genetic risk of developing breast cancer.

We report here the results of an exploratory feasibility study of the colored eco-genetic relationship map (CEGRM), a novel, recently-developed psychosocial assessment tool, which incorporates features of the genetic pedigree, family systems genogram, and ecomap. The CEGRM presents a simple, concise, visual representation of the social interaction domains of information, services, and emotional support through the application of color-coded symbols to the genetic pedigree. The interactive process of completing the CEGRM was designed to facilitate contemporary genetic counseling goals of: (a) understanding the client in the context of her/his social milieu; (b) bolstering client self-awareness and insight; (c) fostering active client participation and mutuality in the counseling interaction; (d) eliciting illuminating social narratives; and (e) addressing outstanding emotional issues. Twenty women participating in a breast imaging study of women from families with BRCA1/2 mutations completed and evaluated various aspects of the CEGRM. We found that efficient construction of the CEGRM was feasible, and that compliance was excellent. Participants developed insights into their social milieu through observing the visual pattern of relationships illustrated by the CEGRM. The process of co-constructing the CEGRM fostered the participant's active involvement in the session, marked by mutuality and increased empathy. In this clinical research context, the participants felt free to share poignant stories about their friends and families. Further studies are planned to refine the CEGRM and to examine its utility in cancer genetics research.

Central challenges facing the national clinical research enterprise.

Medical scientists and public health policy makers are increasingly concerned that the scientific discoveries of the past generation are failing to be translated efficiently into tangible human benefit. This concern has generated several initiatives, including the Clinical Research Roundtable at the Institute of Medicine, which first convened in June 2000. Representatives from a diverse group of stakeholders in the nation's clinical research enterprise have collaborated to address the issues it faces. The context of clinical research is increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants. These factors have contributed to 2 major obstacles, or translational blocks: impeding the translation of basic science discoveries into clinical studies and of clinical studies into medical practice and health decision making in systems of care. Considering data from across the entire health care system, it has become clear that these 2 translational blocks can be removed only by the collaborative efforts of multiple system stakeholders. The goal of this article is to articulate the 4 central challenges facing clinical research at present--public participation, information systems, workforce training, and funding; to make recommendations about how they might be addressed by particular stakeholders; and to invite a broader, participatory dialogue with a view to improving the overall performance of the US clinical research enterprise.

Privacy Enhancing Techniques

To introduce some of the privacy protection problems related to genomics based medicine and to highlight the relevance of Trusted Third Parties (TTPs) and of Privacy Enhancing Techniques (PETs) in the restricted context of clinical research and statistics. Practical approaches based on two different pseudonymisation models, both for batch and interactive data collection and exchange, are described and analysed. The growing need of managing both clinical and genetic data raises important legal and ethical challenges. Protecting human rights in the realm of privacy, while optimising research potential and other statistical activities is a challenge that can easily be overcome with the assistance of a trust service provider offering advanced privacy enabling/enhancing solutions. As such, the use of pseudonymisation and other innovative Privacy Enhancing Techniques can unlock valuable data sources.

Adverse effects: a Pandora’s box for oncology

The provocative report by Shakespeare et al. (1) raises a number of fundamental questions not only for radiation oncology, but for all of oncology. This simple survey opens a true Pandora’s box of ethical and clinical practice issues that are in need of discussion: Do we have adequate evidence to properly characterize the risk of acute and delayed effects from cancer treatment? If not, do we have an obligation to generate the necessary data? If our evidentiary basis for risk is lacking or inferior, what are the implications for the informed consent process and our ability to fairly present treatment alternatives? Additional questions naturally follow: How exactly do we measure adverse effects or “harms” in oncology, and how do we balance them against the benefits? How do we determine “acceptable risk” and who should define it? In this editorial, we reflect on a few of these issues within the context of modern oncology practice and clinical research.

In defense of expert opinion.

Evidence-based medicine, centered on the incorporation of evidence from clinical trials and systematic reviews into the teaching and practice of clinical medicine, explicitly attempts to supplant expert opinion, which is viewed as an antiquated and unreliable form of medical authority. The epistemology of evidence-based medicine categorizes expert opinion as the lowest form of medical evidence, superseded even by methodologically flawed clinical research. When derived from direct clinical experience, however, expert opinion represents an alternative form of medical knowledge, one that may be complementary to empirical evidence. Input from clinical experts is vital to informing the context of clinical research and an appeal to alternate forms of medical knowledge, including expert opinion, is necessary to overcome the intrinsic gap between clinical research and the care of individual patients. Even when the quality and quantity of empirical medical evidence are ideal, expert opinion will remain an integral part of the multifaceted knowledge required for the optimal practice of clinical medicine.

Strategies for Hospital-Wide Dissemination of Psychiatric Rehabilitation Interventions

Abstract An ultimate goal in the development of effective rehabilitation interventions within clinical-research contexts is the dissemination of these techniques to the “typical” treatment setting. Often however, hospital administrators at such settings either see this goal as unattainable, or do not implement a carefully integrated process of staff training and administrative support. In this paper, we describe the steps in an ongoing effort to implement psychiatric rehabilitation practices hospital-wide in a state psychiatric facility. This process has involved a number of critical components including time-limited use of outside experts, focused administrative support and quality assurance, continuing education opportunities, and the establishment of both a unit specializing in rehabilitation interventions that serves as an ongoing training environment for hospital staff, and a core group of practitioners from this program who provide regular external consultation to other hospital programs. These and ...

A decent proposal: ethical review of clinical research

Why Ethical Review? The Moral Context of Clinical Research The Main Job: Protecting Interests of the Research Subject Research Design and Methodology: Built-in Risks Experimental Clinical Practice Balancing Risks and Benefits What is This Thing Called Consent? The Value of a Committee - Expertise Representation and Accountability Good Ethical Review in Practice The Pro-Forma Application Form and its Requirements Ethical Review and the Law Why Local? - The Importance of Variable Circumstances The Special Challenge of Multi-Location Research The Future of Ethical Review.

International use, application and performance of health-related quality of life instruments

Two years ago, scientists at Burroughs Wellcome Company and the Bowman Gray School of Medicine began discussions about the role of patient-based measures of individual function, wellbeing and satisfaction within the context of crosscultural clinical research. These discussions led to a decision to convene an international Board of Advisors (the names appear at the end of this preface) in Research Triangle Park, North Carolina, USA on 25-26 August 1992 to review the present status and future directions for the use, application and performance of health-related quality of life (HRQL) instruments within the context of international clinical trial research. The document (referred to as the White Paper’) that served as the point of departure for the meeting was written by Dr Sally Schumaker and her colleagues, Drs Roger Anderson and Michelle Naughton, of the Bowman Gray School of Medicine in Winston-Salem, North Carolina. Iterative reviews of the document were provided by the Advisory Board members and integrated into the final document. The entire project was supported by the Burroughs Wellcome Company. The need for cross-nationally valid HRQL measures for use in international clinical trials is now recognized by social and medical scientists throughout the world. New and exciting challenges have emerged because the field of clinical research has evolved to the point where drug efficacy is assessed beyong the traditional markers of morbidity and mortality. Questions requiring attention include: “Among experts in the field, are there agreed upon standards to evaluate international HRQL measures?” and ‘What minimum criteria should be required to validate an instrument cross-nationally?’ These were among the issues addressed at the 1992 gathering in North Carolina. HRQL research faces special challenges within the context of international efficacy trials. Vari-

Patient-oriented models for linking primary care and mental health care

Although there has been much importance attached to the relationship between mental health care and general health care, there have been few attempts to systematically describe the nature of the relationships between these two domains of health care. The author reviews other attempts to develop models of interaction between the two systems, describes the dimensions of a patient-oriented set of models for the linkage between mental health and general health care providers, and suggests how these models fit into the overall context of clinical services research at the interface between these two systems of care.

Remote Data Entry and Retrieval: The Human and Administrative Aspects

There has been intense activity during the past 2 years in exploring the applications of personal or microcomputers (PCs) as a means of capturing data emanating from clinical investigations. A number of pharmaceutical companies, including Ives Laboratories, have explored this method. Conceptually, this idea is very appealing. Properly posed to management or the medical monitor, the presenter can argue that this method of capturing data is the most effective (both in cost and time) and superior to other currently available procedures. However, detailed examination of this technology reveals that before this method of data collection can be accepted as viable and effective, especially on a large scale, a number of issues must be resolved. The purpose of this paper is to examine these issues, especially in the context of clinical research as sponsored by the pharmaceutical industry. An alternative approach to remote data entry, utilizing the currently available facsimile transceiver technology, is discussed.