Nurses' role in platelet transfusion clinical trials.

This article describes the crucial role of research nurses in studies coordinated by the NHS Blood and Transplant Clinical Trials Unit (CTU), using two recent trials studying platelet transfusions in adults and neonates as examples. CTU studies are coordinated by trial managers, most of whom are or were registered nurses, which supports relationships with research nurses in participating hospitals. During trials the CTU sustains research nurses with ongoing education and training, and establishes cooperative working between nurses and the unit, and between nurses in different locations. Regular feedback from research nurses guides the design and management of clinical trials.

An international comparison of the clinical trials nurse role.

The collaborative role of clinical trials nurses (CTNs) is crucial to the management of research protocols in clinical settings. As part of a literature review of ten articles, comparisons were made of CTN roles in countries across North America, Europe and the Asia-Pacific region. The research looked at collaborative competencies relating to issues ranging from protocol assessment and informed consent to the research team and study site management. It found that this aspect of CTNs' advanced specialty role in clinical trials research meets the requirements of standards of professional nursing practice in the US, but that in some nations CTNs have different scopes of practice, so more research is needed to clarify and standardise the role.

Treatment with lenalidomide modulates T-cell immunophenotype and cytokine production in patients with chronic lymphocytic leukemia.

BACKGROUND: Lenalidomide, an immunomodulatory agent, has activity in lymphoproliferative disorders. The authors, therefore, evaluated its effects on T-cell immunophenotype and cytokine production in patients with chronic lymphocytic leukemia (CLL). METHODS: To study the immunomodulatory effects of lenalidomide in CLL, the authors recruited 24 patients with untreated CLL enrolled in a phase 2 clinical trial of lenalidomide and obtained peripheral blood specimens for immunologic studies consisting of enumeration of T cells and assessing their ability to synthesize cytokines after activation through T-cell receptor (TCR). RESULTS: After 3 cycles of therapy, patients had a significant reduction in percentage (%) and absolute lymphocyte count (ALC) and an increase in percentage of T cells, percentage of activated CD8(+) T cells producing IFN-γ, and percentage of regulatory T (T(R) ) cells when compared with their respective levels before treatment. After 15 cycles of treatment, responder patients had significant reduction in percentage of lymphocytes and ALC, percentage of activated CD4(+) T cells producing IL-2, IFN-γ, or TNF-α, and percentage of T(R) cells when compared with their perspective levels after 3 cycles of treatment. Furthermore, the numbers of activated CD4(+) T cells producing IL-2, IFN-γ, or TNF-α, activated CD8(+) T cells producing IFN-γ, and T(R) cells normalized to the range of healthy subjects. CONCLUSIONS: Treatment with lenalidomide resulted in the normalization of functional T-cell subsets in responders, suggesting that lenalidomide may modulate cell-mediated immunity in patients with CLL.

The essential role of the clinical research nurse (CRN).

In an age of increasing focus on expanding the opportunity of clinical research trial participation to broader patient populations, the clinical research nurse (CRN) has become an essential member of the clinical research team. The CRN is responsible for many roles and aspects of clinical trial management. Clarification of these roles and responsibilities will be provided in this article.

Gene therapy and informed consent decision making: nursing research directions.

Recent gene therapy clinical trials have demonstrated significant promise for treating a number of genetic neuromuscular disorders. Although nurses are experienced in educating patients and families about the benefits and risks of conventional therapeutics, there are significant challenges for guiding patients through the decision-making phase of gene therapy clinical trial participation. The first part of this review provides an overview and update on neuromuscular gene therapy, including viral delivery principles and historical progress. The second part discusses risk/benefit perception of gene therapy and factors affecting the decision making for patients interested in participating in a trial. Future challenges for gene therapy are targeted high-efficiency delivery, and additional research on developing patient-centered decision support interventions.

Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.

Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.

Nurse research and the law in competent adults.

This article is a summary of issues which nurses face when carrying out research involving competent adults. A recent case of a nurse in Teeside who was struck off as a result of irregularities in conduct during a clinical research trial highlights the importance of standards of care in research being met. The authors focus on two aspects of research - the problems of the consent procedure and the different obligations that might arise from involvement in research. Nurses have a very important role to play in the conduct of research. They, like any other health-care professionals, must make sure that they conduct themselves in accordance with the standards of care of their profession and are accountable for their research conduct.

Towards clarification of the role of research nurses in New Zealand: a literature review.

The demand for research nurses has increased markedly in recent years due to a rapidly expanding clinical research environment. Research nursing is becoming increasingly specialised and nurses now hold central positions in the coordination of clinical trials and management of trial related patient care. However, as a role in transition, research nursing is currently under-recognised and has yet to establish a clear identity and position for itself within nursing and within research. Therefore, the aim of this literature review is to describe the current role of research nurses in clinical trials and explore the professional issues surrounding the role. To provide greater clarification of the role in New Zealand, these findings are examined against the Nursing Council of New Zealand competency requirements for registered nurses. In examining the professional issues surrounding the role, current barriers to adequate recognition of the role are identified and potential strategies to clarify the role and the position of research nurses are put forward.

Proactive nurse management guidelines for managing intensive chemotherapy regimens in patients with advanced gastric cancer.

Patients with advanced gastric cancer have a poor prognosis. Intensive chemotherapy regimens may be effective for the treatment of this disease but may be associated with a significant number of severe adverse events. Optimal management of these adverse events can improve outcome for the patient. Currently, there is little information in the literature about the nursing management of this particular group of patients. This American study involved the nursing management of all patients with gastric or gastroesophageal cancer enrolled in clinical trials at a single center. Patients had close contact with research nurses and received education about adverse events and how to deal with them. Patients completed a detailed treatment diary for each cycle of treatment. Protocols were established for the management of emergent adverse events. The guidelines developed during this study could help to underpin the role of the specialist oncology nurse and improve the management of patients undergoing intensive chemotherapy for gastric and gastroesophageal cancer, with the potential of improving outcome, or at least quality of life, for the patients. The nurses' role should be pivotal in the management of intensive chemotherapy for gastric and gastroesophageal cancer.

Standardized nursing care plan: a case study on developing a tool for clinical research.

The National Institutes of Health have developed a new organizational consortium through a funding mechanism called the Clinical and Translational Science Award. This program funds academic institutions to create a platform for research that expedites the development and delivery of new treatments through open interdisciplinary collaboration. As a result, the adult clinical research center at San Francisco General Hospital is now part of the Clinical and Translational Science Institute at the University of California San Francisco. Nurses on this research unit have begun to employ a standardized nursing care plan that focuses on the particular needs of the research participant, an advancement that if implemented nationwide among all adult clinical research centers will be of paramount importance in fostering a collaborative relationship within the new organizational structure. This standardized nursing care plan will provide research nurses with a tool that will enable them to provide safe and quality patient care.

A process to manage recruitment to multiple competing studies.

Although strategies for decreasing barriers to research participation have been previously published, specific strategies for managing recruitment in the context of multiple, competing studies have not been addressed. This article addresses the development and implementation of a coordinated recruitment core aimed at managing recruitment to multiple studies competing for patients within a breast cancer clinic. The discussion centers around the process used to define the problem and need for change, the proposed change, steps in implementing the change, strategies to facilitate implementation of the change, and initial evaluation, including expected and unexpected benefits. Also included is a discussion of future directions.

Patient and physician attitudes regarding clinical trials in neurofibromatosis 1.

Neurofibromatosis 1 (NF1) is a multisystem genetic disorder that primarily affects the skin (freckling and café-au-lait macules), nervous system (neurofibromas, optic gliomas, and learning disabilities), and skeletal system (pseudoarthroses). The interest in pharmacological intervention for patients with NF1 has grown in recent years. However, little is known about the attitudes and priorities of patients, families, and physicians regarding participation in clinical trials. We surveyed 74 adult patients or parents of patients with NF1 and 69 care providers participating in a neurofibromatosis clinic to assess their willingness to participate in clinical trials and their opinions about which conditions they thought were most important to treat. Both patients and care providers are willing to participate in clinical trials for NF1 and both groups rate malignant peripheral nerve sheath tumors as the most urgent for new treatments. There are concordant views among patients and physicians concerning clinical trials for NF1, and patients do not dismiss participation in placebo-controlled trials. Neuroscience nurses are poised to facilitate the research process from conception through implementation as they take the viewpoints of our study populations into consideration.

A strategy for learning principles and elements of informed consent.

Nurses frequently provide potential study participants with informed consent forms and information regarding involvement in research studies However, there is little information in the nursing literature that emphasizes how to evaluate informed consent documents for appropriateness. The authors present an instructional project for critiquing informed consent documents for content, clarity, readability, and conciseness.

Understanding the placebo effect. Part 2: underlying psychological & neurobiological processes.

Placebo and nocebo effects are interesting and complex phenomena. In this article, I discuss some findings about the psychological and neurobiological processes that may underlie these effects on the basis of studies of pain, Parkinson's disease, and depression. From a psychological perspective, expectancy and conditioning theories have been used to explain placebo and nocebo effects. These psychological processes may be translated into physiological effects through overlapping brain circuits that are important for cognitive information processing, analgesia, and reward expectations. These brain circuits may represent a fundamentally important common underlying pathway that mediates placebo and nocebo effects in many conditions. Understanding these effects is important for designing clinical treatment studies and interpreting their results and is highly relevant for clinical practices.

The role of the clinical trial nurse in the informed consent process.

The purpose of this descriptive study was to elicit information about the current practice of clinical trial nurses in the informed consent process. A 50-item self-administered anonymous questionnaire was completed by a sample of 95 nurses from hospitals affiliated with McGill University in Montreal, Quebec, Canada, who were members of a clinical trial research team whose principal investigator was a physician and whose research participants were competent adults. The nurses were all members of the provincial nurses' association. Clinical trial nurses were found to have an important role in the informed consent process and to experience conflict of interest and other ethical dilemmas as members of clinical trial research teams. There is a need to develop specific practical and ethical guidelines for nurses involved with clinical trial research and to develop educational programs for nurses working in clinical research.

Clinical research and the development of new devices: considerations for nurses.

New investigational drugs and devices are commonly used in critically ill patients. The development of new drugs and the role of the critical care nurse caring for subjects in clinical trials are crucial to the success of the research process. The purpose of this article is to discuss the Food and Drug Administration's regulatory approval process for significant risk investigational devices.

Clinical nurse specialist influence in the conduct of research in a clinical agency.

Clinical nurse specialists (CNSs) have a unique view and understanding of patients in their environment and are a valuable resource that has not been adequately engaged in research, even when CNSs assist researchers in the conduct of research. The purpose of this article is to outline activities for supporting the conduct of research that capitalize on the clinical strengths of the CNS from an ecological framework. To illustrate the contributions of CNSs in the conduct of research, 3 clinical research studies are described. Discussion of these studies within the context of an ecological framework offers a systematic approach to describing the potential involvement of the CNS in the implementation of nursing research.

[Study nurses in Germany--a survey of job-related activities in clinical trials as a basis for a job description and for training curricula]. / Study Nurses in Deutschland--eine Untersuchung ihrer Tätigkeiten bei der Durchführung klinischer Studien.

Until now, the conducting of clinical trials by nurses has scarcely come under scientific examination. Particularly in Germany, the field of activity has only been treated marginally in the health-care and nursing sciences. In Germany, the term 'Study Nurse' is used not only for members of the nursing profession but across disciplines; it is one of the most widely used terms. An explorative, descriptive study has been conducted employing a modified version of the Work Sampling Method. 79 Study Nurses were anonymously surveyed using a self-administered workload catalogue. 85 participated in the survey that focused on demographics, qualifications, and salary. In every workload catalogue, contact with other colleagues as well as job activities and the time spent on each activity were documented over twenty days. Study Nurses are mostly members of the nursing profession. They work mostly at university clinics and are responsible for conducting clinical trials. This applies to all trials that license medicinal products but also for trials initiated by investigators. While trial-specific documentation is their most time-intensive task, the overall role of Study Nurses encompasses a very broad range of activities. For the most part, they work alone and independently but have various contacts mainly to patients and the investigator. Future research should take into consideration the motivation for opting for the job of Study Nurse and the question of whether through their training and experience nurses are better qualified than other healthcare professionals.