French national survey on breast cancer care: caregiver and patient views.

PURPOSE: To improve the quality of care for patients with breast cancer, an analysis of the health-care pathway, considering feedback from both health-care practitioners (HCPs) and patients, is needed. METHODS: Between 2020 and 2022, we conducted a survey at French breast cancer centers and analyzed information from questionnaires completed by HCPs and patients. We collected information on center organization, diagnostic processes, treatment decisions and modalities, supportive care, patient advocacy groups, and work issues. RESULTS: Twenty-three breast cancer centers were included and questionnaires completed by 247 HCPs and 249 patients were analyzed. The centers closely followed the legal French framework for cancer treatments, which includes formal diagnostic announcements, multidisciplinary tumor boards, personalized treatment summaries, and supportive care access. HCPs and patients were satisfied with the time to diagnosis (≤ 2 weeks as evaluated by 75% of patients), time to surgery (mean 61 days), time between surgery and chemotherapy (mean 47 days), and time between surgery and radiotherapy (mean 81 days). Fertility preservation counseling for women under 40 years of age was systematically offered by 67% of the HCPs. The majority (67%) of the patients indicated that they had received a personalized treatment summary; the topics discussed included treatments (92%), tumor characteristics (84%), care pathways (79%), supportive care (52%), and breast reconstruction (33%). Among HCPs, 44% stated that reconstructive surgery was offered to all eligible patients and 57% and 45% indicated coordination between centers and primary care physicians for adverse effects management and access to supportive care should be improved, for chemotherapy and radiotherapy, respectively. Regarding patient advocacy groups, 34% of HCPs did not know whether patients had contact and only 23% of patients declared that they had such contact. For one-third of working patients, work issues were not discussed. Twenty-eight percent of patients claimed that they had faced difficulties for supportive care access. Among HCPs, 13% stated that a formal personalized survivorship treatment program was administered to almost all patients and 37% almost never introduced the program to their patients. Compliance to oral treatments was considered very good for 75-100% of patients by 62% of HCPs. CONCLUSIONS: This study provides an updated analysis of breast cancer care pathways in France. Overall, the initial processes of diagnosis, announcement, and treatment were swift and were in agreement with the best care standards. No barriers to accessing care were identified. Based on the study findings, we proposed several strategies to improve the quality of care for patients in supportive care, coordination with primary care physicians, reconstructive surgery, and fertility preservation access.

Controlled human infection trials: Legitimacy and conditions of implementation in France.

This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called "infectious challenge" trials or "Controlled Human Infection Models", "CHIM") recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability. The recommendations on which the participants of the Round Table came to an agreement are presented as the analysis progresses.

Italian good practice recommendations on management of persons with Long-COVID.

A significant number of people, following acute SARS-CoV-2 infection, report persistent symptoms or new symptoms that are sustained over time, often affecting different body systems. This condition, commonly referred to as Long-COVID, requires a complex clinical management. In Italy new health facilities specifically dedicated to the diagnosis and care of Long-COVID were implemented. However, the activity of these clinical centers is highly heterogeneous, with wide variation in the type of services provided, specialistic expertise and, ultimately, in the clinical care provided. Recommendations for a uniform management of Long-COVID were therefore needed. Professionals from different disciplines (including general practitioners, specialists in respiratory diseases, infectious diseases, internal medicine, geriatrics, cardiology, neurology, pediatrics, and odontostomatology) were invited to participate, together with a patient representative, in a multidisciplinary Panel appointed to draft Good Practices on clinical management of Long-COVID. The Panel, after extensive literature review, issued recommendations on 3 thematic areas: access to Long-COVID services, clinical evaluation, and organization of the services. The Panel highlighted the importance of providing integrated multidisciplinary care in the management of patients after SARS-CoV-2 infection, and agreed that a multidisciplinary service, one-stop clinic approach could avoid multiple referrals and reduce the number of appointments. In areas where multidisciplinary services are not available, services may be provided through integrated and coordinated primary, community, rehabilitation and mental health services. Management should be adapted according to the patient's needs and should promptly address possible life-threatening complications. The present recommendations could provide guidance and support in standardizing the care provided to Long-COVID patients.

Elaboration of guideline for monitoring in relative bioavailability / pharmaceutical bioequivalence study by the sponsor / Elaboração de diretriz para monitoramento em biodisponibilidade relativa / estudo de bioequivalência farmacêutica pelo patrocinador / Elaboración de la directriz para el seguimiento en la biodisponibilidad relativa / estudio de bioequivalencia farmacéutica por parte del promotor

For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified.

Para registro de medicamentos genéricos e similares, é necessária a realização de testes de equivalência farmacêutica (EF) e bioequivalência farmacêutica (BF). Para a realização desses testes, são contratados centros de pesquisa devidamente habilitados, que precisam ser monitorados pelo patrocinador legalmente responsável pelas atividades. Há também a recomendação do Documento das Américas de realizar monitoramentos periódicos para verificar o cumprimento dos requisitos de qualidade, Procedimentos Operacionais Padrão, Boas Práticas Clínicas (BPC), Boas Práticas de Laboratório (BPL), de marco regulatório aplicável, bem como de cumprimento do protocolo do estudo. Assim, o monitoramento é um processo metódico e documentado para avaliar o grau de adesão do centro ao desenho planejado para a avaliação das formulações. Para tanto, a implantação de uma diretriz padronizada e de fácil preenchimento é uma ferramenta muito importante para garantir uma avaliação consistente e manter a memória organizacional dos itens avaliados por monitores designados pelo patrocinador, contribuindo para a melhoria constante dos centros contratados e apoiando rastreabilidade dos estudos. Este artigo forneceu uma visão sistêmica do processo de evidência relacionado principalmente à bioequivalência farmacêutica, com a diretriz de monitoramento resumindo os itens de maior relevância a serem verificados.

Para el registro de medicamentos genéricos y similares, es necesario realizar pruebas de equivalencia farmacéutica (EP) y de bioequivalencia farmacéutica (PB). Para llevar a cabo estas pruebas se contratan centros de investigación debidamente cualificados, que deben ser supervisados por el promotor, que es el responsable legal de las actividades. Para ello, es la recomendación del Documento de las Américas, el monitoreo periódico para verificar el cumplimiento de los requisitos de calidad, los Procedimientos Operativos Estándar, las Buenas Prácticas Clínicas (BPC), las Buenas Prácticas de Laboratorio (BPL), del marco regulatorio aplicable, así como del cumplimiento del protocolo del estudio. Así, la monitorización es un proceso metódico y documentado para evaluar el grado de adhesión del centro al diseño previsto para la evaluación de las formulaciones. Para ello, la implantación de una pauta estandarizada y de fácil cumplimentación es una herramienta muy importante para garantizar una evaluación consistente y mantener la memoria organizativa de los elementos evaluados por parte de los monitores designados por el promotor, contribuyendo a la mejora constante de los centros contratados y apoyando la trazabilidad de los estudios. Este trabajo proporcionó una visión sistémica del proceso de evidencia relacionado principalmente con la bioequivalencia farmacéutica, con la pauta de monitoreo que resume los ítems de mayor relevancia a ser verificados.

Management of Children with Acute Asthma Attack: A RAND/UCLA Appropriateness Approach.

Bronchial asthma is the most frequent chronic disease in children and affects up to 20% of the pediatric population, depending on the geographical area. Asthma symptoms vary over time and in intensity, and acute asthma attack can resolve spontaneously or in response to therapy. The aim of this project was to define the care pathway for pediatric patients who come to the primary care pediatrician or Emergency Room with acute asthmatic access. The project was developed in the awareness that for the management of these patients, broad coordination of interventions in the pre-hospital phase and the promotion of timely and appropriate assistance modalities with the involvement of all health professionals involved are important. Through the application of the RAND method, which obliges to discuss the statements derived from the guidelines, there was a clear increase in the concordance in the behavior on the management of acute asthma between primary care pediatricians and hospital pediatricians. The RAND method was found to be useful for the selection of good practices forming the basis of an evidence-based approach, and the results obtained form the basis for further interventions that allow optimizing the care of the child with acute asthma attack at the family and pediatric level. An important point of union between the primary care pediatrician and the specialist hospital pediatrician was the need to share spirometric data, also including the use of new technologies such as teleconsultation. Monitoring the progress of asthma through spirometry could allow the pediatrician in the area to intervene early by modifying the maintenance therapy and help the patient to achieve good control of the disease.

Aproximación al estado del arte de los comités de monitoreo de datos en ensayos clínicos / Approach to the state of the art of data monitoring committees in clinical trials

Introducción: En 1967 se estableció, por primera vez, un comité de monitoreo de datos, en un estudio de mortalidad cardiovascular; desde entonces su uso se ha incrementado debido a su valor para garantizar la seguridad de los sujetos participantes en ensayos clínicos y la validez e integridad de los datos. Se realizó una exploración documental de los últimos 20 años, sobre aspectos relacionados con los requisitos de creación y funcionamiento de los comités de monitoreo de datos a nivel mundial, con los objetivos de mostrar el desarrollo alcanzado en el establecimiento de los comités de monitoreo de datos e identificar sus características fundamentales. Desarrollo: Existe un incremento en la producción documental sobre los comités de monitoreo de datos, liderado por angloparlantes de países desarrollados, con franco aumento de publicaciones sobre el tema en el último quinquenio, superior en 50 por ciento a los 15 años anteriores. Este fenómeno lo provoca el auge de la industria farmacéutica y biotecnológica, los altos costos de investigación y desarrollo de medicamentos, la necesidad de introducir nuevos fármacos y el incremento de las exigencias regulatorias. Se describen las características estructurales, requisitos clínicos y metodológicos para el establecimiento de los comités. Conclusiones: Existe alto desarrollo de los comités de monitoreo de datos en los ensayos clínicos, con tendencia al incremento de su uso en los últimos años. Los comités de monitoreo de datos se caracterizan por requerimientos clínicos y metodológicos para su establecimiento(AU)

Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the validity and integrity of the data. A documentary exploration of the last 20 years was carried out, on aspects related to the requirements for the creation and operation of data monitoring committees worldwide, with the aim of showing the development achieved in the establishment of data monitoring committees and identify its fundamental characteristics. Development: There is an increase in documentary production on data monitoring committees, led by English speakers from developed countries, with a clear increase in publications on the subject, in the last five-year period, 50% higher than in the previous 15 years. This phenomenon is caused by the rise of the pharmaceutical and biotechnology industry, the high costs of drug research and development, the need to introduce new drugs and the increase in regulatory requirements. The structural characteristics, clinical and methodological requirements for the establishment of the committees are described. Conclusions: There is a high development of data monitoring committees in clinical trials, with a tendency to increase their use in recent years. Data monitoring committees are characterized by clinical and methodological requirements for their establishment(AU)

Socio-economic burden and resource utilisation in Italian patients with chronic urticaria: 2-year data from the AWARE study.

INTRODUCTION: In Italy, the real-world evidence on the extent of adherence to guidelines and the benefits of recommended therapeutic medications and their impact on the quality of life (QoL) of H1-antihistamines (H1-AH) refractory chronic urticaria (CU) patients is limited. METHODS: AWARE (A World-wide Antihistamine-Refractory chronic urticaria patient Evaluation) was a global prospective, non-interventional study of CU in real-world setting which included patients aged ≥18 years with a medically confirmed diagnosed of CU present for more than 2 months. In this study, the disease characteristics, pharmacological treatments and patient-reported outcomes (PROs) are reported. RESULTS: In total, 159 patients from 24 study centres in Italy completed the study. At baseline, 221 (89.5%) and 8 (3.2%) patients had chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), respectively, while 18 (7.3%) patients had concomitant CSU and CIndU. For CSU patients, mean dermatology life quality index and CU quality of life questionnaire scores reduced to 3.0 ± 4.9 and 14.6 ± 18.6 at Month 24 from baseline scores of 7.5 ± 6.6 and 33.2 ± 19.5, respectively, indicating an improvement in QoL. This was reflected in their work-life as work productivity impairment reduced considerably after 2 years. Only 71.9% CSU patients had a prior treatment, while during the study, 96.8% of the patients were treated with a medication. At baseline, only 52.9% CSU patients reported nonsedating H1-antihistamines as first-line of treatment in prior medication, this increased to 89.6% during current medication. CONCLUSION: This study shows that CSU has a considerable socio-economic burden and an improvement in QoL can be achieved in CSU patients if an appropriate therapeutic path is followed.

[A survey on French hospital physicians'certification to the good clinical practices]. / Enquête sur la certification aux bonnes pratiques cliniques en recherche académique.

Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitalière network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals.

Creating a "Good Clinical Practices Inspection" Authentic Online Learning Environment through Educational Design Research.

Educational design research (EDR) was applied to address the challenge of providing more public health professionals with opportunities to develop their knowledge and skills related to Good Clinical Practices (GCP) inspections. The conduct of clinical research in accordance with the principles of GCP is necessary to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. The safety and efficacy of pharmaceuticals, medical devices, and other healthcare products depend upon the application of GCP. The World Health Organization has been providing a global face-to-face GCP Inspection course in Indonesia for a decade, but budget constraints only allow this course to be offered once a year to 15 participants. This paper describes how the move from a face-to-face course to an online authentic learning environment was accomplished through EDR and concludes with a discussion of design principles derived from the research. The results of a beta test of the new online course with 12 participants are also described in the paper.

Creating and testing a GCP game in an asynchronous course environment: The game and future plans.

INTRODUCTION: The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions. METHODS: Students were invited to participate in the GCP Kaizen game as part of their 100% online academic Masters during the Spring 2019 semester. The structure of the game consisted of 75 original multiple choice and 25 repeated questions stemming from fictitious vignettes that were distributed across 10 weeks. Each question presented a teachable rationale after the answers were submitted. At the end of the game, a satisfaction survey was issued to collect player satisfaction data on the game platform, content, experience as well as perceptions of GCP learning and future GCP concept application. RESULTS: There were 71 total players who participated and answered at least one question. Of those, 53 (75%) answered all 100 questions. The game had a high Cronbach's alpha, and item analyses provided information on question quality, thus assisting us in future quality edits before re-testing and wider dissemination. CONCLUSIONS: The GCP Kaizen game provides an alternative method for mandated GCP training using principles of gamification. It proved to be a reliable and an effective educational method with high player satisfaction.

Arranging good clinical practices training and trial monitoring for a vaccine efficacy study during a public health emergency of international concern.

The 2014-2015 outbreak of Ebola Virus Disease (EVD) in West Africa was unprecedented in size and scope. The World Health Organization, government of Guinea and other partners undertook a field trial of efficacy of an Ebola vaccine in Guinea, with a parallel immunogenicity study in front-line workers. However, several obstacles had to be overcome. One was the need to teach Good Clinical Practices to a large group of field workers who had never participated in vaccine clinical trial research. Because the trial design was complex, performing this efficacy trial during an Ebola outbreak would have been challenging even for experienced investigators. For field workers who had never previously participated in a clinical trial, this constituted a daunting challenge. Another challenge was to provide independent monitoring to document the quality and validity of the field trial data to support future regulatory agency licensure. Here we discuss how these challenges were overcome, and what lessons can be drawn for the future. Intensive GCP was expeditiously arranged for 251 clinical study staff on-site in Guinea. The trials were initiated within days after completion of training. Monitoring (100% of participants in the efficacy trial and 50% in the immunogenicity trial) began at the onset of the trials. Early monitoring detected many minor errors but prompt feedback and guidance from the monitors, who explained the mistakes and proposed corrective actions, diminished error frequency as the trials progressed. Monitoring later in the trials showed what one would expect in a study conducted by experienced investigators. Should a vaccine field trial have to be hastily arranged during a future emerging disease outbreak in a developing country setting, our methods of training and monitoring could provide a model.

Clinical trial master file migration: A preordained step for a centralized electronic trial master file.

The need to speed up clinical trial processes in a cost-effective manner, increased importance of data integrity, and ensuring timely compliance to regulatory requirement updates regarding the Trial Master File (TMF), has made the pharmaceutical industry delineate the requirement to maintain a centralized TMF with quality control. With the exponential increase in the number of sponsors using centralized electronic TMF (eTMF), the shift of trend positively impacts the need for data migration requirements in the TMF space. With an objective to serve the readers handling migration projects, this review article discusses the data migration requirements in clinical operations and eTMF in clinical trials, possible techniques to consider avoiding anticipated roadblocks, and a few other key points. The article also focuses on steps to be taken post migration to ensure meeting the quality of the migrated data in terms of regulatory compliance.

Issues and Ethical Considerations in Pharmaco-oncogenomics.

The rapid advancements of treatment modalities and vast amounts of information being generated through novel technologies, paint the picture of a very promising future, one that will allow for a more efficient and precise DNA sequencing and potentially more tailored cancer therapies for patients. However, with all these advances we must address the ethical and legal considerations each one of these technologies will raise. This is a necessity in order for advancement, not to stand in the way of science and development, but as a safeguard in protecting humanity and our personal genetic information.

Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Evaluating the effects of food on health in a world of evolving operational challenges.

In a context of rising interest in food and supplement clinical trials, operational considerations for the set-up and conduct of these research projects remain difficult to address in the absence of a harmonized referential. Food trials tend to be more pragmatic than drug trials which are usually more elucidatory. However, comparing them is difficult because the objectives they serve are different. Food trials are usually conducted to evaluate the effect of food products on the prevention or mitigation of symptoms, not the treatment or cure of a condition. In this article we explain these main differences and discuss several key operational and regulatory aspects to consider when dealing with clinical research evaluating the effect of food products on health-related biomedical or behavioral outcomes.

Right to try? fosfoetanolamina, di bella e stamina: uma análise Ítalo-Brasileira / Right to try? phosphoethanolamine, di bella and stamina cases: an Italo-Brazilian analysis

Este trabalho possui como objetivo a análise do fornecimento judicial de medicamentos em fase de teste laboratorial, por meio de um estudo comparado dos casos italianos di Bella e Stamina e do caso brasileiro da fosfoetanolamina da Universidade de São Paulo. Para tanto, foram considerados os percursos judiciais dos três casos, as opiniões doutrinárias e repercussões médicas anunciadas pela mídia e pelos órgãos oficiais interessados. Como resultado, observou-se, no Brasil, uma tendência jurisprudencial que desponta, ainda que não confirmada, no sentido de que a realização do direito à saúde não pode prescindir da segurança médica, afastando-se, em princípio, a obrigação do Estado de fornecer tratamentos experimentais por meio de sua rede de saúde. Na Itália, por outro lado, após a experiência judicial e médica negativa decorrente de dois casos emblemáticos, a Corte Constitucional italiana (Corte Costituzionale) parece ter mudado de orientação, no sentido da não obrigação do fornecimento de tratamento experimental por parte do Servizio Sanitario Nazionale. No âmbito das ações com pretensão de curas compassivas, as normas técnicas, representadas pelas boas práticas clínicas, surgem como zíper de união entre o direito, a ciência e a ética.

This paper reports on an analysis of court orders that determine experimental therapies and provides a comparative study of the Italian Di Bella and Stamina cases and the Brazilian Phosphoethanolamine case. The judicial sentences on the three cases were considered, along with their medical outcome and media repercussion. As a result of the comparison, it was observed that the Brazilian Constitutional Court is tending towards the non-recognition of a “right to try”, even though the Court’s official opinion remains to be seen. In Italy, on the other hand, after the negative judicial and medical experience concerning two emblematic cases, the opinion of the Italian Constitutional Court seems to have changed, indicating that the State is no longer forced to provide experimental therapies through the public health system. In the scope of these judicial lawsuits that claim compassionate cures, the technical framework, represented by the good clinical practices guidelines, comes about as the “zipper” that binds together law, science and ethics.

Dificultades percibidas por expertos relacionadas con la ejecución de ensayos clínicos en Cuba / Difficulties in performing clinical assays in Cuba found by experts

Introducción: los ensayos clínicos constituyen la piedra angular de la investigación clínica actual. Su número se ha incrementado en los últimos años en Cuba por el desarrollo acelerado de la industria médico-farmacéutica y biotecnológica. Este tipo de investigación requiere que las instituciones donde se ejecutan cuenten con condiciones estructurales que garanticen el cumplimiento de las buenas prácticas clínicas. Objetivos: analizar las dificultades percibidas por expertos para la ejecución de ensayos clínicos en el Sistema Nacional de Salud. Métodos: se realizó una investigación cualitativa de tipo descriptiva entre los meses de febrero-octubre de 2013. Se entrevistaron 15 expertos divididos en dos grupos según función: grupo 1, con 7 diseñadores de protocolos y grupo 2, con 8 investigadores clínicos. La información se analizó y clasificó en unidades de significado y categorías. Resultados: ambos grupos consideraron que la presión asistencial, la falta de estimulación al investigador, escasos recursos materiales y deficiente capacitación de los recursos humanos, constituyeron dificultades significativas. Adicionalmente, los expertos del grupo I señalaron como barrera la poca cantidad de sitios certificados y la lenta aprobación de los ensayos clínicos por los comités de ética. Conclusiones: las dificultades percibidas por ambos grupos de expertos hablan a favor del insuficiente apoyo institucional que tienen los ensayos clínicos, que además no son vistos como una necesidad del Sistema para dar respuesta a problemas de salud(AU)

Introduction: clinical assays are the cornerstone of present clinical research. They have increased in the last few years in Cuba due to the accelerated development of the drug and biotechnological industry. This type of research work requires that institutions where it is performed have adequate structural conditions in place to guarantee the compliance with good clinical practices.Objectives: to analyze the difficulties found by two groups of experts as to the performance of clinical assays in the national health care system.Methods: descriptive-type qualitative research study conducted from February to October 2013. Fifteen experts were interviewed and divided into two groups by their type of function: group 1 with 7 protocol designers and group 2 with 8 clinical researchers. The gathered information was analyzed and classified into meaning units and categories.Results: both groups considered that pressure upon medical assistance, lack of incentives for the researcher, few material resources and poor training of human resources were the most significant difficulties. Additionally, the members of Group I stated that the low number of certified sites and the slow approval of clinical assays by the ethical commissions are barriers to work.Conclusions: the difficulties that both groups of experts found reveal the little support of institutions for the clinical assay performance that is not seen as a need of the health care system to resolve health problems(AU)

Dificultades percibidas por expertos relacionadas con la ejecución de ensayos clínicos en Cuba / Difficulties in performing clinical assays in Cuba found by experts

Introducción: los ensayos clínicos constituyen la piedra angular de la investigación clínica actual. Su número se ha incrementado en los últimos años en Cuba por el desarrollo acelerado de la industria médico-farmacéutica y biotecnológica. Este tipo de investigación requiere que las instituciones donde se ejecutan cuenten con condiciones estructurales que garanticen el cumplimiento de las buenas prácticas clínicas. Objetivos: analizar las dificultades percibidas por expertos para la ejecución de ensayos clínicos en el Sistema Nacional de Salud. Métodos: se realizó una investigación cualitativa de tipo descriptiva entre los meses de febrero-octubre de 2013. Se entrevistaron 15 expertos divididos en dos grupos según función: grupo 1, con 7 diseñadores de protocolos y grupo 2, con 8 investigadores clínicos. La información se analizó y clasificó en unidades de significado y categorías. Resultados: ambos grupos consideraron que la presión asistencial, la falta de estimulación al investigador, escasos recursos materiales y deficiente capacitación de los recursos humanos, constituyeron dificultades significativas. Adicionalmente, los expertos del grupo I señalaron como barrera la poca cantidad de sitios certificados y la lenta aprobación de los ensayos clínicos por los comités de ética. Conclusiones: las dificultades percibidas por ambos grupos de expertos hablan a favor del insuficiente apoyo institucional que tienen los ensayos clínicos, que además no son vistos como una necesidad del Sistema para dar respuesta a problemas de salud(AU)

Introduction: clinical assays are the cornerstone of present clinical research. They have increased in the last few years in Cuba due to the accelerated development of the drug and biotechnological industry. This type of research work requires that institutions where it is performed have adequate structural conditions in place to guarantee the compliance with good clinical practices. Objetives: to analyze the difficulties found by two groups of experts as to the performance of clinical assays in the national healthcare system. Methods: descriptive-type qualitative research study conducted from February to October 2013. Fifteen experts were interviewed and divided into two groups by their type of function: group 1 with 7 protocol designers and group 2 with 8 clinical researchers. The gathered information was analyzed and classified into meaning units and categories. Results:: both groups considered that pressure upon medical assistance, lack of incentives for the researcher, few material resources and poor training of human resources were the most significant difficulties. Additionally, the members of Group I stated that the low number of certified sites and the slow approval of clinical assays by the ethical commissions are barriers to work. Conclusions: the difficulties that both groups of experts found reveal the little support of institutions for the clinical assay performance that is not seen as a need of the health care system to resolve health problems(AU)

Sitios clínicos, eslabón fundamental en la calidad de un ensayo clínico / Clinical sites, a fundamental pillar for the quality of a clinical assay

Introducción: el Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) tiene como función fundamental la realización de ensayos clínicos a nuevos productos de la Industria Biotecnológica y Farmacéutica cubana. Desde el año 2008 tiene implementado un Sistema de Gestión de la Calidad que trabaja basado en la mejora continua de sus procesos. Un factor de suma importancia para el buen desarrollo y garantía de los resultados de sus investigaciones, es el trabajo que brindan los sitios clínicos. Objetivo: determinar las principales dificultades detectadas en los monitoreos realizados en los sitios clínicos. Métodos: la evaluación de la calidad del trabajo de los sitios clínicos en el primer semestre del año 2011, se realizó teniendo en cuenta el cumplimiento o no de los requisitos planteados en la Guía de Buena Práctica Clínica para la investigación clínica. Resultados: las principales dificultades se enmarcaron en los acápites de la institución, en los requisitos correspondientes a los recursos necesarios, a aspectos vinculados con el Comité Ética Institucional y en lo referido a las calificaciones y acuerdos con el investigador; aspectos estos que inciden en el cumplimiento de las Buenas Prácticas Clínicas por parte de los sitios clínicos, lo cual repercute en la calidad del servicio brindado por el CENCEC. Conclusiones: este trabajo sirve como punto de partida para la mejora continua del Sistema de Gestión de Calidad de la organización a fin de encaminar los esfuerzos a la total aplicación del principio de las relaciones mutuamente beneficiosas con los proveedores(AU)

Introduction: the National Coordinating Center of Clinical Assays (CENCEC in Spanish) has the fundamental function of performing clinical assays in new products from the Cuban biotechnological and drug industry. Since 2008, the Center has the quality management system in place to continuously improve its processes. A key factor for good development and assurance of the results of its research is the work of the clinical sites. Objective: to find out the main difficulties in the monitoring of the clinical sites. Methods: the evaluation of the work quality of the clinical sites in the first semester of 2011 took into consideration the fulfillment or non-fulfillment of the requirements set in the Good Clinical Practice Guide for the clinical research. Results: the main difficulties are found in the sections of the institutions, in the requirements for necessary resources, in issues linked to the institutional ethics committee and in qualifications and agreements with the researcher; these are aspects having an impact on the fulfillment of Good Clinical Practices by the clinical sites, which also affects the quality of service rendered by CENCEC. Conclusions: this paper may serve as a starting point for ongoing improvement of the quality management system of the organization in order to direct our efforts to the total implementation of the principle of mutually beneficial relationships with the suppliers(AU)

Certificación en Buenas Prácticas Clínicas de un sitio clínico / Certification of Good Clinical Practice of a clinical center

El mundo desarrollado con su creciente competitividad impone aún mayores exigencias en el cumplimiento de los estándares para el registro de los productos médicos y ha comenzado la certificación de los sitios clínicos para la realización de los ensayos clínicos, lo cual le brinda mayor credibilidad a los resultados obtenidos de las investigaciones realizadas en ellos y por ende, le da mayor prestigio y competitividad al producto. El objetivo de este trabajo es mostrar la implementación de un sistema de Buenas Prácticas Clínicas en la ejecución de los ensayos clínicos para la Certificación en Buenas Prácticas Clínicas. Se realizó un estudio descriptivo en el Hospital General Dr Juan Bruno Zayas Alfonso en Santiago de Cuba, entre Junio 2010 y Agosto 2011. La investigación constó de tres momentos y abarcó todas las acciones realizadas durante la implementación. Finalmente se estableció un sistema de Buenas Prácticas Clínicas que resultó en la Certificación del Hospital en Buenas Prácticas Clínicas por parte del Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos para la realización de ensayos clínicos(AU)

The developed world with its increasing competitiveness imposes even greater demands in meeting the medical product registration standards and certification. According to this, it has begun the certification of the clinical centers conducting clinical trials, which gives more credibility to the results from research carried out there and therefore greater prestige and competitiveness to the product. The objective of this paper was to show the implementation of a Good Clinical Practice system in the performance of clinical trials in order to attain the Certification. A descriptive study was made in Dr Juan Bruno Zayas Alfonso general hospital from June 2010 and August 2011 in Santiago de Cuba province. The research consisted of three stages and included all the actions taken during the implementation. Finally, a Good Clinical Practice system was put in place that allowed the Certification of Good Clinical Practices for conduction of clinical trials to be given to the hospital by the Regulatory Center of State Control of Drugs and Medical Equipment and Devices(AU)