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.

El rol de la enfermera en los ensayos clínicos: un nuevo reto para la Enfermería / Nurses’ role in clinical trials: a novel challenge in nursing

OBJETIVO: describir el rol de la enfermera en ensayos clínicos (EC), definirlas competencias, funciones y responsabilidades que debe tener y de qué manera mejora la calidad y la fiabilidad de cualquier EC. MÉTODO: se efectuó una revisión bibliográfica de los últimos 20 años en las bases de datos: CINHAL, Medline (Pubmed). Se utilizaron las palabras clave: enfermera coordinadora, enfermera de ensayos clínicos, ensayo clínico y rol de enfermera coordinadora. RESULTADOS: el análisis de los 30 artículos seleccionados permitió que se generaran dos categorías principales en las que se describe el rol quela enfermera desempeña en los EC: "Importancia de la enfermera coordinadora de EC" (además de recopilar datos, incluye el manejo de los mismos, y con frecuencia presta atención y tratamiento en un contexto complejo y aislado, lo que exige conocimiento y aplicación de responsabilidades éticas y profesionales), y "Funciones de la misma" (según Green (2011), son seis: 1. Persona de referencia para el paciente; 2.Persona de referencia y contacto entre los distintos miembros del equipo investigador; 3. Manejo de los datos; 4. Recogida de muestras biológicas;5. Administración de fármacos y medicamentos; y 6. Conocimiento de protocolos y monitorización).CONCLUSIONES: el rol de la enfermera coordinadora resulta esencial para asegurar la calidad y rigurosidad de cualquier EC, ya que hace de enlace entre paciente, promotor y resto del equipo investigador, minimizando errores y aumentando la adherencia al tratamiento

PURPOSE: to describe the role of nurses in clinical trials (CT), to define competences, tasks and responsibilities nurses should have and the way they can improve quality and reliability in any CT. METHODS: a literature search and review was carried out covering the last 20 years; the following databases were used: CINHAL, Medline (Pubmed). Searching keywords were: coordinating nurse, clinical trials nurse, clinical trial and coordinating nurse role. RESULTS: a review of 30 selected articles showed two main categories reporting nurses' role in CT: Importance of a CT coordinating nurse(besides data collection, nurse's role includes data management, and frequently care and treatment in a complex and isolated setting, which requires expertise, along with ethical and professional competences),and Tasks of a CT coordinating nurse (according to Green, the following six tasks: 1- Reference staff member for patients, 2- Reference member and person in charge of contact among research team members, 3- Data management, 4- Biological samples collection, 5-Drugs and medicines administration, and 6- Knowledge of protocols and monitoring).CONCLUSIONS: the role of a coordinating nurse is critical to ensure quality and rigor in any CT, acting as a liaison between patients, sponsor and other members of the research team, minimizing mistakes, and enhancing adherence to therapy

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.

Heparinización versus salinización en catéteres periféricos cortos para extracciones de sangre en ensayos clínicos / Heparinization versus salinization in short peripheral catheters for blood draws in clinical trials

Objetivo: explorar si el comportamiento dinámico del torrente venoso es adecuado, siendo la prioridad el reflujo venoso, tras realizar repetidas extracciones de sangre en el marco de un ensayo clínico, a fin de poder realizar una extracción que se considere limpia y de calidad para las determinaciones posteriores. Método: la población estuvo constituida por pacientes con cáncer de ovario, glioblastoma cerebral y cáncer de mama localmente avanzado, con tratamiento en el marco de ensayos clínicos Fase I, donde el sistema venoso periférico no está previamente tratado ni dañado. Se estudiaron 83 puntos de extracción, dentro de las primeras24 horas de la colocación del catéter, eliminando del estudio el primer punto de punción, donde no hay conservación previa. Resultados: en relación a la facilidad para el reflujo, la vía heparinizada refluye fácilmente en un 82,9% de los casos, con dificultad en un 14,6% y no refluye en un 2,4% de los casos. En las vías salinizadas, refluye fácilmente en un 39,5% de los casos, con dificultad en un 55,8% y no refluye en un 4,7%. Referente a la calidad de la muestra extraída, medida a través de la hemólisis de la misma, en las vías mantenidas con suero heparinizado, se observa que las muestras se hemolizan en un 19,5% de los casos, y en las vías mantenidas con suero salino las muestras se hemolizan en un 39,5%.Conclusiones: la heparina sódica a baja concentración (20 UI/ml) en comparación con suero salino, disminuye los problemas asociados al reflujo del catéter, incrementando el número de catéteres periféricos que refluyen sin dificultad a la vez que disminuye el grado de hemólisis de la muestra, si bien hay que tener en cuenta que las vías no permanecen en las mismas condiciones que al principio pasadas las primeras horas de su canalización aunque se mantienen un período muy corto de tiempo, máximo 24 horas (AU)

Objective: to explore whether the dynamic behavior of the venous blood stream is suitable, with the priority being the venous reflux, following repeated blood draws as part of a clinical trial, in order to perform an extraction we consider to be clean and of quality for subsequent determinations. Method: the population consisted of patients with ovarian cancer, brain glioblastoma and locally advanced breast cancer, with treatment as part of Phase I clinical trials, where the peripheral venous systemis not pre-treated or damaged. 83 extraction sites were studied, within the first 24 hours of catheter insertion, eliminating from the study the first puncture site, where there is no prior preservation. Results: regarding the ease of reflux, the heparinised route refluxed more easily in 82,9% of cases, with difficulty in 14,6% of cases, and did not reflux in 2,4% of cases. In salinized routes, it refluxed easily in 39,5% of cases, with difficulty in 55,8% of cases, and did not refluxin 4,7% of cases. Concerning the quality of the extracted sample, as measured by the hemolysis of the sample, from the routes maintained with heparinized saline solution, samples lysed in 19,5%of cases, and in routes maintained with saline solution, samples lysed in 39,5% of cases. Conclusions: at low concentrations, sodium heparin (20 IU/ml) compared with saline solution reduces the problems associated with catheter reflux, increasing the number of peripheral catheters that refluxed easily while decreasing the degree of hemolysis of the sample. However, it should be noted that the routes do not remain in the same conditions as in the beginning past the first hours of canalization although they are maintained for a very short period of time, maxi -mum 24 hours (AU)

Clinical trial nurse's role in safety reporting.

The clinical trial nurse (CTN) can have a substantial amount of responsibility for clinical trials and can perform many roles in the management of clinical trials. Although new opportunities for the registered nurse in clinical trials have emerged in recent years, there remains to be a dearth of literature surrounding the important roles of the CTN in clinical trials. The CTN is a specialty-nursing role that is unfamiliar to many, including some nurses. Therefore, it is important to address this gap in the literature and enlighten the nursing profession and others about the roles of the nurse in clinical trials. This article aims to explore and provide an overview of the CTN's role in safety reporting. Safety reporting is a significant component of clinical trials by protecting the rights, safety, and welfare of subjects. The CTN integrates and utilizes his or her knowledge, experience, skills, and sound ethical principles when performing the duties of this role. This allows the CTN to be a vital member in the safety-reporting process and in the protection of subjects.

Clinical trials in integrative therapies.

OBJECTIVES: To review clinical trials in natural products and mind-body therapies for oncology symptom management, to discuss issues related to developing clinical trials in this area, and outline examples of rigorous and innovative study design. DATA SOURCES: Peer reviewed literature. CONCLUSION: Most of the evidence for the integrative therapies reviewed is derived from phase II trials, and is considered preliminary. More research is needed in these therapies to clearly articulate their role in the management of oncology symptoms. Innovative strategies and methodologies for studying integrative therapies have been demonstrated. IMPLICATIONS FOR NURSING PRACTICE: It is necessary to critically evaluate the literature to be able to educate patients about integrative therapies. Investigators should expand on well-designed studies that demonstrate clinically important effects. Dissemination trials may be a good strategy, once data exists, to move integrative therapies into the care of patients.

The role of the clinical trial nurse in Italy.

PURPOSE: To assess the role of the Clinical Trials Nurse (CTN) and to evaluate the quality of the job performed by Clinical Trials Nurses (CTNs) in Italy. METHODS: The study design was descriptive. The sample included 30 CTNs in Italy who were involved in conducting clinical trials in the last years. Respondents completed the Italian Clinical Trials Nursing Questionnaire (CTNQ) developed to measure frequency and importance of clinical trials nursing activities. Data analyses included descriptive statistics, Student's t-test and Chi-Square test. RESULTS: Thirty out of 34 CTNs consented to participate. Respondents were more involved in the experimental drug management, in the protocol implementation and, partially, in the informed consent process. CTNs have a marginal position with respect to the protocol assessment and planning, subject recruitment, data management. CTNs reported high rates for the importance evaluation. Number of years in the nursing role was significantly associated with data management related activities (p = 0.016). Items with minor response rate differences between frequency and importance were not statistically significant (p values ranging from 0.087 to 0.911). The CTNs reported to be autonomous and competent; however, they lack and/or do not perform some nursing-related responsibilities and/or activities. CONCLUSIONS: Although CTNs are not involved in all of the activities listed on the CTNQ, most of them are fully aware to be a key member of research teams. Overall, the Italian CTN role is mostly practical task-oriented and focuses little on data management and organizational activities.

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.

El cumplimiento de la buena práctica de enfermería en los ensayos clínicos / O cumprimento da boa prática da enfermagem nos ensaios clínicos / Fulfillment of good nursing practices in clinical trials

La ejecución de ensayos clínicos exige dedicación y adherencia a un conjunto de procedimientos y normativas esenciales con el propósito de obtener resultados válidos para la evaluación y posible registro sanitario de un nuevo producto. En este artículo se muestra la propuesta cubana para el cumplimiento de altos estándares de calidad en las Buenas Prácticas Clínicas para la participación de enfermería en este tipo de estudios.

Clinical trial execution demands dedication and adherence to a group of procedures and essential rules, to obtain valid results to evaluate and the possible sanitary registry of a new product. In this article the Cuban proposal for high standard quality in Good Clinical Practices for the participation of nursing in this type of studies is shown.

A execução de ensaios clínicos exige dedicação e aderência a um conjunto de procedimentos e regulamentos essenciais com o propósito de obter resultados válidos para a avaliação e possível registro sanitário de um novo produto. Neste artigo se mostra a proposta cubana para o cumprimento de altos padrões de qualidade nas Boas Práticas Clínicas para a participação de enfermagem neste tipo de estudos.

Evaluation of factors associated with recruitment in hematological clinical trials: a retrospective cohort study.

The objectives of this study were to measure the recruitment, to study characteristics associated with recruitment, and to explore reasons for non-recruitment in clinical trials for malignant hematological diseases. Trials opened between 2002 and 2008 were selected. If the patient fulfilled the main criteria of the protocol, all eligibility criteria of the protocol were assessed. A total of 1394 patients-protocol were identified in 17 protocols (697 patients, since a patient could have been eligible for more than one protocol) and 195 patients-protocol (186 patients) of these fulfilled the main criteria of the protocol. Among the 195 patients-protocol, 133 (68·2%) fulfilled all the eligibility criteria and 45 (23·1%) were recruited. Patients, physicians, and protocol characteristics were not associated with recruitment. The most common reasons for not being recruited were as follow: 40·7%, not fulfilling all eligibility criteria; 31·3%, protocol not being proposed according to the chart; and 22·7%, patients' refusal.

Delineating the role of a cohort of clinical research nurses in a pediatric cooperative clinical trials group.

PURPOSE/OBJECTIVES: To describe the roles and responsibilities of the clinical research nurse (CRN). DESIGN: A descriptive design was used to reveal the roles of pediatric oncology CRNs. SETTING: The Children's Oncology Group (COG) password protected Web site. SAMPLE: 85 nurses who performed clinical research associate work within COG. METHODS: The Clinical Trials Nursing Questionnaire was used to investigate the roles and responsibilities of CRNs. MAIN RESEARCH VARIABLES: Protocol assessment, protocol planning, subject recruitment, informed consent process, investigational product, implementation and evaluation, data management, and professional nursing role. FINDINGS: The study found that 55% of respondents (n = 47) were employed in a hospital setting, the majority (81%) had more than five years of oncology experience, and the average age of respondents was 45.56 years (range = 24-65 years). CRNs rated all role components as very important, with the consent process being of greatest importance. Eighty-nine percent reported experiencing autonomy and independence in the role. CONCLUSIONS: Clinical specialization of RNs has increased significantly in the past several decades. Acknowledging that nurses are responsible for performing many different roles that are critical to the successful completion of clinical trials is crucial. IMPLICATIONS FOR NURSING: Evaluation of this dual role is still in its infancy, but articulating the role of CRNs in the conduct and context of clinical research is an important first step.

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.

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.