Background: Clinical trials represent a significant percentage of the time and cost to bring a drug through the development process and to Food and Drug Administration approval. Despite how critical these trials are to the drug development process, many studies are underpowered due to low accrual. This translates to valuable questions regarding the safety and effectiveness of new agents being left unanswered, requiring additional time and studies. A call for reform of the industry has been made by stakeholders in the clinical research enterprise; however, national change is slow. Thus sites that conduct clinical research must find methods to increase efficiency within the burdensome system currently in place. Throughout cancer centers adhering to the National Cancer Institute (NCI) Cancer Center Support Grant guidelines, efficiencies have been explored individually; however, there is a gap in knowledge on what factors affect sites system-wide. This dissertation seeks to examine factors that affect clinical trial efficiency in the areas of study activation looking at the outcome of local clinical trial accrual. Methods: Protocol and site-specific clinical trial administration data was collected regarding closed, interventional treatment and supportive care clinical trials from cancer centers adhering to NCI Cancer Center Support Grant guidelines during a five-year time period (2009-2014). Study characteristic analyses and hierarchical regression modeling was used to explore the effect of feasibility committee use and protocol workload on the outcomes of clinical trial accrual and time to activate a clinical trial. Sensitivity analyses were utilized when considering protocol workload to account for studies that had not yet closed to accrual, and thus were not included in this dataset. In addition, protocol- and site-specific variables were used to build regression models used to predict clinical trial accrual. Sensitivity, specificity, and accuracy were compared to the current standard, the institutional disease team. Results: Sixteen centers contributed a total of 5,787 protocols (range 93-697 studies). These studies accrued 49,319 subjects. Of all studies, 1,053 (18%) accrued zero subjects. Disease teams predicted 221% of actual accrual. Seven institutions submitted protocol workload information for 2,133 studies (36.9%) and 14,229 accruals (28.9%). Controlling for effect modifiers and interactions, and adjusting for institution, a statistically significant increase in clinical trial accrual and decrease in activation time was seen with the use of a feasibility committee. Regulatory protocol workload was significantly associated with clinical trial accrual and activation time; however, a single, definitive protocol workload was not identified that both minimized activation time and maximized clinical trial accrual. Protocol workload most often maximized accrual at workloads of between 3.5 and 5.0 protocols per staff member/FTE and minimized activation time at workloads between 1.0 and 1.9 protocols per staff member/FTE. Regression models predicted accrual more accurately than disease teams at all 16 centers, with site-specific models consistently having the best performance (versus an adjusted, hierarchical model). Conclusion: Despite institutional differences in variable association with accrual and activation times, the utilization of a feasibility committee was shown to improve clinical trial accrual as well as decrease activation time. Using systematic methods for examining study activation and accrual efficiencies resulted in the development of models that predicted clinical trial accrual better than the current standard (disease team prediction) at all participating centers. Further research is needed to better define and determine optimal workload. This information and these models may better inform study planning and resource allocation decisions by local stakeholders (administrators and investigators) in the clinical research enterprise.

Esta dissertação tem como foco a Pesquisa Clínica em Emergência e, em primeiro lugar, procura definir e determinar situações de emergência. Apresentamos os aspectos próprios do setor de emergência e tentamos caracterizar as pessoas que buscam esse tipo de atendimento. Realizamos uma pesquisa nacional e internacional sobre as normas regulamentadoras que orientam a pesquisa clínica tentando apontar os aspectos regulatórios que interessam à Pesquisa Clínica em Emergência. Percorremos o Código de Nuremberg, a Declaração de Helsinque e as normas regulatórias de pesquisa no Brasil, nos EUA e na Europa. Foram pesquisadas regulamentações que autorizam o início de projetos de pesquisa clínica sem a obtenção de consentimento informado, muito embora seja obrigatória a sua coleta na primeira oportunidade viável, proveniente do próprio participante ou de seu representante. Foram discutidos, igualmente, os aspectos éticos das pesquisas clínicas, especialmente os princípios, as virtudes e os direitos dos participantes e pesquisadores envolvidos. Foram realizados levantamentos do volume de pesquisas realizadas em Emergência que estão cadastradas no Clinical Trials e no sistema GPPG 8.0. No mundo as pesquisas em Emergência totalizam 0,68% dos projetos cadastrados. No Brasil, utilizando os dados do Clinical Trials, esta frequência se reduz a 0,24%. No HCPA as pesquisas em Emergência representam 0,79% dos projetos realizados. Por fim, elaboramos um produto, na forma de uma lista de recomendações, relativa às questões importantes ao propor a adesão de uma pessoa à pesquisa e também ao conduzir projeto de pesquisa clínica na emergência. Essa lista deve ser conferida e confirmada pelo pesquisador antes de iniciar a pesquisa. O produto elaborado é fundamental para a realização adequada de pesquisas clínicas em ambiente de Emergência, envolvendo questões relativas à Dignidade, Liberdade, Vulnerabilidade e Integridade do participante e do pesquisador, assim como o método a ser empregado. / This dissertation focuses on Emergency Clinical Research and, firstly, seeks to define and determine emergency situations. We present the aspects of the emergency sector and try to characterize the people who seek this type of care. We conduct national and international research on regulatory standards that guide clinical research by attempting to identify the regulatory aspects of Emergency Clinical Research. We went through the Nuremberg Code, the Helsinki Declaration and the regulatory standards of research in Brazil, the US and Europe. We searched for regulations that authorize the initiation of clinical research projects without obtaining Informed Consent, although it is mandatory to collect it at the earliest possible opportunity, from the participant himself or his representative. The ethical aspects of clinical research, especially the principles, virtues and rights of the participants and researchers involved, were also discussed. Surveys on the volume of research carried out in Emergency, registered in Clinical Trials and in the GPPG 8.0 system were done. In the world, the surveys in Emergency totaled 0.68% of the registered projects. In Brazil, using Clinical Trials data, this frequency is reduced to 0.24%. In the HCPA, the researches in Emergency represent 0,79% of the realized projects. Ultimately, we have developed a product in the form of recommendations on important issues in proposing a person's adherence to research and also in conducting a clinical research project in the emergency room. This list must be checked and confirmed by the researcher before starting the research. The elaborated product is fundamental for the proper conduct of Clinical Research in Emergency environment, involving issues related to Dignity, Freedom, Vulnerability and Integrity of the participant and the researcher, as well as the method to be used.

I argue for two main theses that are at odds with the positions of many clinical researchers and philosophers who write on the ethics of clinical research. The first is that certain types of clinical trials, namely, randomized clinical trials with double or triple blinding and a placebo group are generally necessary to establish that a medical intervention is effective in treating a certain type of disease or disorder. The second main thesis is that such trials are generally not ethically impermissible. My minimalist defense of clinical trials differs from most defenses of clinical trials found in the literature. I feel that the ethical permissibility of clinical trials can be judged by answering yes to the following questions: 1) Is the potential experimental subject competent to exercise his autonomy and his right of self determination in order to enroll in the clinical trial? 2) Is the potential experimental subject informed about the nature of risk and benefit involved in his participation in the clinical trial? 3) Is the trial scientifically/ epistemically valid? 4) Will the trial attempt to answer a scientific question or questions of value? I argue that competent persons have the right to enroll in scientifically valid clinical trials so long as they are informed and consent to participate.

Magister Curationis - MCur / Clinical research nurses are at the frontline of clinical research. They act as nurse leaders in the area of patient-orientated research. This leadership role requires that they work independently with limited support from other nurses. The nursing practice of clinical research nurses’ associates patient care with research protocols, administration duties, management responsibilities, and role specific authority. At hospitals in the Western Cape, clinical research nurses support principal investigators in the conducting of clinical research. It was unclear how clinical research nurses in nursing units in southern suburbs, Cape Town, Western Cape Province experienced their self-leadership role in nursing practice. The aim of the study was to explore and describe the experiences of clinical research nurses’ self- leadership role in nursing practice in nursing units in the southern suburbs of Cape Town, Western Cape. In this study; a phenomenological, exploratory, descriptive, and contextual design was followed. The population consisted of all the clinical research nurses (n = 22) at Western Cape hospitals and health care institutions in the southern suburbs. Purposive sampling was applied according to selection criteria. Unstructured individual interviews were conducted until data saturation occurred. These interviews took place at a private office in the southern suburbs of the Cape Town and lasted between 45 minutes and an hour. Observation and field notes were taken during the interviews. Data was analysed by using open coding and data triangulation. The researcher applied Lincoln and Guba’s (1985) model of trustworthiness. Four themes and twenty one categories emerged from the data analysis. The findings emphasised that the clinical research nurses’ experienced their self-leadership role in nursing as an evolutionary process. The evolutionary role required that they needed to develop strategies with the aim of surviving the initial tedious and daunting phase that facilitated the development of skills needed for collaborative partnerships with stakeholders. As her general confidence increased, the clinical research nurse would be able to recognise her professional attributes and use self-leadership behaviour to enhance her daily practice. Appropriate self-leadership behaviour would assist the clinical research nurse to successfully navigate the complex, dynamic clinical research environment. Guidelines were developed from the four themes that were the result of the data analysis; namely the initial tedious and daunting phase, working in pursuit of collaborative action, personal traits of the clinical research nurse, and self-leadership behaviour. The UWC Higher Degree Committee at the Faculty of Community and Health Sciences and the Senate Research Committee respectively approved this research project. No risks were anticipated for participants in the study.

No description available.

Centros de pesquisa clínica (CPC) devem ter infraestrutura adequada, equipe treinada e gerenciamento de processos bem definidos, para atender as particularidades dos projetos científicos, as Boas Práticas Clínicas (BPC), e as diretrizes e normas nacionais e internacionais que regem este ambiente. Um sistema de gestão da qualidade é fator primordial para o sucesso de um CPC durante a condução de ensaios clínicos. Neste contexto, a ANVISA instituiu em 2009 a Instrução Normativa nº 4 (IN4) que dispõe sobre o guia de Inspeção em BPC. O objetivo deste estudo foi desenvolver e validar um questionário eletrônico capaz de medir o desempenho dos centros participantes da Rede Nacional de Pesquisa Clínica (RNPC) em uma auditoria de qualidade baseada nas BPC. Avaliamos a correlação do nosso instrumento com o guia de inspeção em BPC disposto na IN4 ANVISA e estudamos a influência de um gerente de qualidade em relação ao cumprimento aos requisitos. Foi realizado um estudo transversal nos 32 centros participantes da RNPC, por meio da aplicação de um questionário eletrônico, legitimado por uma validação de conteúdo. As questões foram agrupadas em três domínios (infraestrutura, estrutura organizacional (EO) e processos). Os dados foram pontuados de acordo com o cumprimento (1) ou não cumprimento (0) em BPC. As questões do nosso questionário foram arbitrariamente correlacionadas aos itens da IN Nº 4, atribuímos (0) ponto às questões conformes e (1) para não conforme. Esta correlação foi realizado por meio de coeficiente de correlação de postos de Spearman. O índice de cumprimento para atendimento aos itens críticos e maiores (ICCM) foi calculado para cada domínio usando a equação ICCM = -1 * (Escore IN4) + valor total escore para dado domínio e comparado usando ANOVA não-paramétrica. Os dados foram agrupados de acordo com a presença ou ausência de um gerente de qualidade no centro de pesquisa e os escores foram comparados usando o teste de Mann-Whitney, com P valor <0.05. 27 centros responderam ao questionário (84,4%). Nosso instrumento representa aproximadamente 40% dos itens do roteiro de inspeção da IN4 ANVISA. A pontuação obtida com o questionário correlaciona-se significativamente ao escore correspondente à IN4/ANVISA (r-=0,95, -0,89 a -0,98, CI95%, P<0.0001). A mediana do ICCM foi menor que 75% em todos os domínios estudados. Apenas 14,81% dos centros contam com a presença de um gerente de qualidade. A presença de um gerente de qualidade foi associada ao melhor desempenho nos domínios infraestrutura e estrutura organizacional (P<0.05). O instrumento desenvolvido para medir o desempenho em BPC apresenta alta correlação com a Instrução Normativa Nº 4 ANVISA e poderia ser utilizado para auditoria interna de qualidade. A IN4/ANVISA mostrou ser muito rigorosa e todos os centros participantes da RNPC apresentaram pelo menos uma não conformidade em itens críticos ou maiores. A presença de um gerente de qualidade pode ajudar a melhorar o desempenho em qualidade em centros de pesquisa clínica / Clinical research centers (CRC) must have an adequate infrastructure, trained staff and well defined management process in order to conduct scientific clinical research protocols with distinct demands and to fulfill the regulatory rules including good clinical practices (GCP) and national or international additional regulatory rules. A quality management system plays a significant role in the success or failure of a CRC in conducting clinical trials. In this context, the Brazilian Health Surveillance Agency (ANVISA), published in 2009 a guide regarding quality audits in the CRC (The Normative Statute #4 of the Agência Nacional de Vigilância Sanitária - IN4 ANVISA). The aim of this study was to develop and validate an electronic questionnaire to measure how CRC that is part of the National Clinical Research Network (Rede Nacional de Pesquisa Clínica/RNPC) performed in a quality audit, using as a source document the GCP. We also evaluated the correlation between our instrument and IN4/ANVISA guide and studied the influence of a quality manager on the level of compliance with quality requirements. It was a transversal study that evaluated 32 CRC of the RNPC. They fulfilled an electronic questionnaire, validated by contend valid index. The questions were divided into tree domains (infrastructure (I), organization structure (OS), focused on human resources and process (P)). Data were scored according compliance (1) or non-compliance (0) with GCP. The questions between our questionnaire where arbitrary related to IN4/ANVISA guide and scored as non-conformity (1) or conformity (0). The correlation of the two measurements above was done using a Spearman rank method. The critical and major non-conformities index (ICCM) obtained with IN4/ANVISA score was calculated for each study domain using the equation ICCM=-1*score + maximal domain score and compared using non-parametric ANOVA. Data were grouped according the presence or absence of a CRC quality manager and the scores compared using Mann-Whitney rank test. The P valor was set to <0.05. Results: 27 CRCs answered the questionnaire (84,4%). Our instrument covered around 40% of all items checked by IN4/ANVISA inspection quality guide. The score obtained with our questionnaire significantly correlates with IN4/ANVISA score (r-=0,95, -0,89 to -0,98, CI95%, P<0.0001). The median of ICCM was lesser than 75% for all domain studied. Only 14,8 % of CRCs had a quality manager. The presence of a quality manager was associated with best performance in infrastructure and OS scores studied (P<0.05). The instrument designed to measure performance GCP showed high correlation with IN4/ANVISA guide and could be used to perform the internal quality audit. The IN4/ANVISA guide showed to be very strict and all CRC presented at least one critical or major quality non-conformities. The presence of quality manager could help CRC improve quality performance

Centros de pesquisa clínica (CPC) devem ter infraestrutura adequada, equipe treinada e gerenciamento de processos bem definidos, para atender as particularidades dos projetos científicos, as Boas Práticas Clínicas (BPC), e as diretrizes e normas nacionais e internacionais que regem este ambiente. Um sistema de gestão da qualidade é fator primordial para o sucesso de um CPC durante a condução de ensaios clínicos. Neste contexto, a ANVISA instituiu em 2009 a Instrução Normativa nº 4 (IN4) que dispõe sobre o guia de Inspeção em BPC. O objetivo deste estudo foi desenvolver e validar um questionário eletrônico capaz de medir o desempenho dos centros participantes da Rede Nacional de Pesquisa Clínica (RNPC) em uma auditoria de qualidade baseada nas BPC. Avaliamos a correlação do nosso instrumento com o guia de inspeção em BPC disposto na IN4 ANVISA e estudamos a influência de um gerente de qualidade em relação ao cumprimento aos requisitos. Foi realizado um estudo transversal nos 32 centros participantes da RNPC, por meio da aplicação de um questionário eletrônico, legitimado por uma validação de conteúdo. As questões foram agrupadas em três domínios (infraestrutura, estrutura organizacional (EO) e processos). Os dados foram pontuados de acordo com o cumprimento (1) ou não cumprimento (0) em BPC. As questões do nosso questionário foram arbitrariamente correlacionadas aos itens da IN Nº 4, atribuímos (0) ponto às questões conformes e (1) para não conforme. Esta correlação foi realizado por meio de coeficiente de correlação de postos de Spearman. O índice de cumprimento para atendimento aos itens críticos e maiores (ICCM) foi calculado para cada domínio usando a equação ICCM = -1 * (Escore IN4) + valor total escore para dado domínio e comparado usando ANOVA não-paramétrica. Os dados foram agrupados de acordo com a presença ou ausência de um gerente de qualidade no centro de pesquisa e os escores foram comparados usando o teste de Mann-Whitney, com P valor <0.05. 27 centros responderam ao questionário (84,4%). Nosso instrumento representa aproximadamente 40% dos itens do roteiro de inspeção da IN4 ANVISA. A pontuação obtida com o questionário correlaciona-se significativamente ao escore correspondente à IN4/ANVISA (r-=0,95, -0,89 a -0,98, CI95%, P<0.0001). A mediana do ICCM foi menor que 75% em todos os domínios estudados. Apenas 14,81% dos centros contam com a presença de um gerente de qualidade. A presença de um gerente de qualidade foi associada ao melhor desempenho nos domínios infraestrutura e estrutura organizacional (P<0.05). O instrumento desenvolvido para medir o desempenho em BPC apresenta alta correlação com a Instrução Normativa Nº 4 ANVISA e poderia ser utilizado para auditoria interna de qualidade. A IN4/ANVISA mostrou ser muito rigorosa e todos os centros participantes da RNPC apresentaram pelo menos uma não conformidade em itens críticos ou maiores. A presença de um gerente de qualidade pode ajudar a melhorar o desempenho em qualidade em centros de pesquisa clínica / Clinical research centers (CRC) must have an adequate infrastructure, trained staff and well defined management process in order to conduct scientific clinical research protocols with distinct demands and to fulfill the regulatory rules including good clinical practices (GCP) and national or international additional regulatory rules. A quality management system plays a significant role in the success or failure of a CRC in conducting clinical trials. In this context, the Brazilian Health Surveillance Agency (ANVISA), published in 2009 a guide regarding quality audits in the CRC (The Normative Statute #4 of the Agência Nacional de Vigilância Sanitária - IN4 ANVISA). The aim of this study was to develop and validate an electronic questionnaire to measure how CRC that is part of the National Clinical Research Network (Rede Nacional de Pesquisa Clínica/RNPC) performed in a quality audit, using as a source document the GCP. We also evaluated the correlation between our instrument and IN4/ANVISA guide and studied the influence of a quality manager on the level of compliance with quality requirements. It was a transversal study that evaluated 32 CRC of the RNPC. They fulfilled an electronic questionnaire, validated by contend valid index. The questions were divided into tree domains (infrastructure (I), organization structure (OS), focused on human resources and process (P)). Data were scored according compliance (1) or non-compliance (0) with GCP. The questions between our questionnaire where arbitrary related to IN4/ANVISA guide and scored as non-conformity (1) or conformity (0). The correlation of the two measurements above was done using a Spearman rank method. The critical and major non-conformities index (ICCM) obtained with IN4/ANVISA score was calculated for each study domain using the equation ICCM=-1*score + maximal domain score and compared using non-parametric ANOVA. Data were grouped according the presence or absence of a CRC quality manager and the scores compared using Mann-Whitney rank test. The P valor was set to <0.05. Results: 27 CRCs answered the questionnaire (84,4%). Our instrument covered around 40% of all items checked by IN4/ANVISA inspection quality guide. The score obtained with our questionnaire significantly correlates with IN4/ANVISA score (r-=0,95, -0,89 to -0,98, CI95%, P<0.0001). The median of ICCM was lesser than 75% for all domain studied. Only 14,8 % of CRCs had a quality manager. The presence of a quality manager was associated with best performance in infrastructure and OS scores studied (P<0.05). The instrument designed to measure performance GCP showed high correlation with IN4/ANVISA guide and could be used to perform the internal quality audit. The IN4/ANVISA guide showed to be very strict and all CRC presented at least one critical or major quality non-conformities. The presence of quality manager could help CRC improve quality performance

The continued investigation into the experiences of individuals with schizophrenia who participate in biomedical research trials is necessary in order to understand participants’ perspectives, motivations, attitudes, values, and beliefs. As important stakeholders in the clinical research process, participant feedback is significant and can help shed light on, not only their experiences, but also deepen understandings when it comes to clinical trial participants’ perceptions of informed consent and personal autonomy. Conducting ethical research demands the exploration of these issues and specifically targeting this vulnerable group helped to address a gap in the literature. This study was conducted for InSite Clinical Research and gathered data in the form of in-depth semi-structured interviews and a short survey instrument with 20 low-income adults diagnosed with schizophrenia that participate in clinical research trials. Findings indicate overall positive research experiences, with motivations aligning with previous research when it comes to trial participation including: altruism, personal benefit, access to medications, financial incentives, and psychosocial treatment. Learning about their illness and themselves, autonomy, and debriefing were also particularly important within this group. Unique to this sample were findings of friendship. Trust in the research staff was identified as a major underlying value and shaping factor impacting informed consent decisions. These conclusions have implications for recruitment and informed consent practices at InSite Clinical Research.

Introdução: O Hospital das Clínicas da Universidade Federal de Pernambuco (HCPE) faz parte da rede de hospitais universitários que são gerenciados pela Empresa Brasileira de Serviços Hospitalares (EBSERH). Em 2014, a EBSERH lançou o Programa de Pesquisas Clínicas Estratégicas para o Sistema Único de Saúde visando a implementação de um modelo de gestão de pesquisas clínicas na rede e, em 2016, o HCUFPE obteve financiamento para implantar um Centro de Pesquisa Clínica na instituição. Objetivo: Desenvolver o planejamento estratégico para a implantação do Centro de Pesquisa Clínica do HCUFPE através do método do Balanced Scorecard. Método: Estudo observacional e descritivo com mapeamento de dados sobre as pesquisas da instituição. Foi desenvolvido o instrumento de coleta de dados no REDCap© com questões fechadas relativas ao perfil do grupo de pesquisa e questões abertas, para composição da matriz SWOT. A aplicação do instrumento foi realizada através de entrevistas com os líderes de grupos de pesquisa. Foi realizada a análise de conteúdo de Bardin através do software Nvivo© e a partir desta, foi elaborado o planejamento estratégico através do método do Balanced Scorecard (BSC). Resultados: Foram identificados90 grupos de pesquisa, a partir da consulta aos registros no setor de pesquisa do hospital. No período de 2015 a 2017, foram registrados 381 projetos de pesquisa, dos quais 91% vinculados às atividades de ensino do hospital e da universidade. Foram entrevistados 29 líderes de pesquisa que pontuaram como pontos fortes para a realização de projetos de pesquisa no hospital o fato de já existirem grupos de pesquisa bem estruturados e a possiblidade de geração de conhecimento e como oportunidades, os avanços na prática clínica. As principais dificuldades citadas foram a inexistência de área física própria e a obtenção e gerenciamento de recursos financeiros para a pesquisa. Conclusão: A partir do mapeamento situacional da pesquisa no HC-UFPE, e da determinação das necessidades dos pesquisadores foi possível traçar iniciativas estratégicas com o objetivo de implementar o Centro de Pesquisa Clínica. O gerenciamento das atividades de pesquisa parece ser essencial para que as metas estabelecidas sejam alcançadas em curto espaço de tempo. / Introduction: The clinical hospital of the federal university of Pernambuco (HC-UFPE) is part of the network of university hospitals that are managed by the brazilian company of hospital services (EBSERH). In 2014, EBSERH launched the strategic clinical research program for the unified health system to implement a clinical research management model in the network and in 2016, the HC-UFPE obtained funding to establish a clinical research center in the institution. Objective: to develop the strategic planning for the implementation of the HCUFPEClinical Research Center through the balanced scorecard method. Method: observational and descriptive study with mapping of data about the institution's research. Conducted interviews with leaders of hospital research groups who were recorded and transcribed to perform SWOT analysis and Bardin content analysis. Results: a total of 90 research groups were identified, from the consultation to the records in the hospital's research sector. Registered 381 research projects in the hospital, from 2015 to 2017, of which, 159 residences, 132 graduate, 40 graduation, 35 clinical trials, 12 pbic, and 3 others. We applied questionnaires to 29 research leaders on the scientific production and infrastructure demand of the research center. the strengths of the institution are: the existence of well-structured research groups, the possibility of generating knowledge, producing improvements in clinical practice and give visibility to the hospital. The main difficulties cited were the acquisition and management of financial and human resources for research, the inexistence of its own physical area and material for research in the institution. Conclusion: Established strategic initiatives: create a course of good clinical practices, offer advice on the Plataforma Brasil to researchers, elaborate internal regulations for the research, reduce time of submission in the CEP and debureaucracy. The use of the BSC method was adequate as a strategy to manage university hospital research.

Introduction : Depuis les premiers implants dentaires Bränemark, les techniques chirurgicales et les matériaux implantaires ont évolué. La référence en terme de matériau implantaire est le Titane. Cependant, d’autres matériaux comme le Zircone ont été proposés pour suppléer le Titane en cas d’allergie au Titane mais aussi pour améliorer la bio-intégration de l’implant dentaire et l’esthétique. Les facteurs de risques d’échec implantaire des implants en Titane incluent, entre autre, l’hygiène orale, la consommation de tabac et la mise en charge immédiate. Objectif : L’étude ZIR-ROC a donc été menée dans le but d’étudier le taux de survie de ces implants zircone après 2 ans de suivi, de recueillir des informations sur l’intégration tissulaire des implants et de rechercher les facteurs de risque d’échec des implants en Zircone. Matériel et méthode : l’étude ZIR-ROC a été menée dans le service de chirurgie orale du CHU de Montpellier sur des implants monobloc en Zircone de la société Paris Implant®. La pose de 43 implants a été déterminée pour permettre l’analyse statistique des résultats. Le forage et l’insertion des implants ont été réalisés à l’aide du système de chirurgie guidée 2ingis®. La variable principale pour évaluer l’ostéo-intégration des implants a été le score délivré par le Periotest®. 22 variables secondaires ont été recueillies tels que les indices gingivaux et de plaque ainsi que l’analyse rétro-alvéolaire. Les données ont été relevées juste avant la chirurgie implantaire, ainsi qu’à 1 semaine, 4 semaines, 5 mois, 1 an et 2 ans. La méthode de Kaplan-Meier, le modèle de Cox et les analyses en composantes principales ont été utilisés pour l’analyse statistique. Résultats : Tous les implants ont présenté une bonne stabilité primaire post-opératoire (valeurs du Periotest comprises entre -8 et +1 ; moyenne à -5,7). Le taux d’échec implantaire a atteint 31% après les 5 premiers mois d’ostéo-intégration. Une mobilité clinique a été observée pour les implants perdus. Les facteurs de risque décrits dans la littérature ont été retrouvés dans le modèle de Cox avec une significativité pour la consommation de tabac et d’alcool et sans significativité statistique pour la densité osseuse ou encore la mise en place d’une couronne provisoire. Par ailleurs, la présence de plaque et d’inflammation gingivale a été observée en faible quantité sur les implants en Zircone. Discussion et conclusion : Le Zircone apparaît comme un matériau biocompatible pour des implants dentaires. Les causes des échecs implantaires précoces observés sont probablement multiples et cette étude n’a pas permis de démontrer l’implication seule de la Zircone dans ces échecs. La recherche des facteurs d’échecs implantaires a conduit à évaluer la technique chirurgicale utilisée pour cette étude mais aussi le dessin de l’implant. De plus, une étude in vitro comparant des implants à base de Zircone et de Titane a été entreprise pour évaluer l’affinité de cellules souches d’origine dentaire pour les 2 matériaux. / Introduction: Since first Bränemark dental implants were implanted, operative surgery and materials for implantation have evolved. Titanium was the gold standard for dental implant material. But others materials like Zirconium were studied in replacement of Titanium due to allergy, bio-integration end aesthetic reasons. Contributing risk factors of Titanium implant failure include oral hygiene, tabacco and early loading among others factors. Objective: The aim of this clinical study was to evaluate survival rate of Zircon implants after 2 years, to collect information for tissue integration of Zirconium implant and to identify risk factors for Zircon implant failure. Material and Methods: ZIR-ROC study, conducted in the Oral Surgery Departement in Montpellier University Hospital, used zircon monobloc (ZIR-ROC®) implants (Paris Implant Society®). 43 implants were required for statistical analysis. Drilling and implantation were conducted with 2ingis® surgical guide system. The Periotest® value was the first endpoint for the implant osseointegration analysis. Gingival and dental plaque indices as well as intraoral X-ray analysis were part of the 22 secondary variables. Data were collected just after implantation surgery, and then, 1 week, 4 weeks, 5 months, 1 year and 2 years after implantation. Kaplan-Meier method, Cox regression model and principal component analysis were used for statistical analysis. Results: All implants showed postoperative optimal primary stability (Periotest® values between -8 and +1; mean: -5,7). Implants failure rate reached 31 percent after the 5 initial months of osseointegration. Clinical mobility was observed for the failed implants. Risk factors published in the scientific literature were observed in the Cox regression model with significant statistical effect for tobacco and alcohol consumption but without significant statistical effect for osseous density or even temporary crown insertion. Furthermore, gingival inflammation and dental plaque presence were low on Zircon implant. Discussion and Conclusion: Zirconium remains a biocompatible material for dental implantation but there were probably many reasons for the observed early implant failures and this study could not demonstrate the only involvement of Zirconium based material. Operative surgery used in this clinical study and the design of the implants were studied for researching other risk factors. In addition, an in vitro study comparing Zirconium versus Titanium as gold standard, was conducted for testing affinity of dental stems cells on Titanium and Zirconium-based dental materials.