Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 5.801
Filtrar
3.
Clin Trials ; 18(2): 226-233, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33530721

RESUMEN

Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution's research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors' experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.


Asunto(s)
/terapia , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/organización & administración , Investigación Biomédica/ética , Investigación Biomédica/organización & administración , Comités de Ética en Investigación , Ética en Investigación , Prioridades en Salud , Recursos en Salud , Humanos , Proyectos de Investigación
4.
Ethics Hum Res ; 43(2): 19-27, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33565280

RESUMEN

Employees are often considered a vulnerable research population due to concerns about consent and confidentiality, but there is insufficient guidance regarding their ethical inclusion in research. In the context of Covid-19, frontline health care workers comprise a particularly relevant research population in light of their risks of viral exposure and psychological strain, among other factors. They may therefore be targeted for research conducted at their place of employment and benefit from participating in such research. Beyond Covid-19, there are other circumstances in which health care workers may be considered for inclusion in research conducted by or with the involvement of their colleagues and employers. As investigators, sponsors, institutional review boards, and others assess the ethical permissibility of these scenarios, as well as relevant protections, we recommend systematic consideration of social and scientific value, validity, fairness, risks and benefits, voluntary consent, respect, and independent review. There is often good reason to specifically target health care workers for inclusion in Covid-19 research (beyond convenience), and they should not be excluded from research offering the prospect of direct benefit. However, additional safeguards may be necessary in employer-based research to avoid scientific bias, promote voluntariness, and solicit stakeholder input. Research personnel should be permitted to enroll in their own Covid-19 studies only when participation offers them the prospect of unique benefits.


Asunto(s)
Comités de Ética en Investigación , Personal de Salud/ética , Investigadores , Investigación , Personal de Salud/organización & administración , Humanos
5.
Mayo Clin Proc ; 96(1): 165-173, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33413815

RESUMEN

Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.


Asunto(s)
Investigación Biomédica/ética , Eticistas , Comités de Ética en Investigación , Ética en Investigación , Bancos de Muestras Biológicas , Humanos , Pandemias
6.
Trials ; 22(1): 90, 2021 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-33494785

RESUMEN

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.


Asunto(s)
Aspirina/administración & dosificación , Aterosclerosis/prevención & control , Comités de Ética en Investigación/normas , Proyectos de Investigación/normas , Prevención Secundaria/métodos , Adulto , Aspirina/efectos adversos , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Humanos , Consentimiento Informado/normas , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto/ética , Estudios Multicéntricos como Asunto/normas , Participación del Paciente , Ensayos Clínicos Pragmáticos como Asunto/ética , Ensayos Clínicos Pragmáticos como Asunto/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Medición de Riesgo/normas , Resultado del Tratamiento
7.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artículo en Inglés | MEDLINE | ID: mdl-33341309

RESUMEN

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.


Asunto(s)
Investigación Biomédica/ética , /prevención & control , Experimentación Humana/ética , Consentimiento Informado/ética , /patogenicidad , Antivirales/administración & dosificación , /inmunología , Comités de Ética en Investigación/organización & administración , Voluntarios Sanos , Experimentación Humana/legislación & jurisprudencia , Humanos , Selección de Paciente/ética , Vacunación/ética , Organización Mundial de la Salud
8.
Pediatrics ; 147(3)2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33334920

RESUMEN

It is widely agreed that an effective response to the coronavirus disease 2019 pandemic needs to include a vaccine that is safe and effective for minors. However, many current vaccine trials have no plans for when to enroll minors. Others have recently proposed enrolling minors as young as 12 years old. This lack of a systematic approach raises 2 concerns. Waiting too long to enroll minors could unjustly deny minors and their families the benefits of a vaccine and has the potential to delay an effective response to the pandemic by a year or longer. At the same time, enrolling minors too soon runs the risk of exposing them to excessive risks. With these concerns in mind, in the present article, we propose recommendations for when and how to enroll minors in vaccine trials for the coronavirus disease 2019.


Asunto(s)
Ensayos Clínicos como Asunto/normas , Voluntarios Sanos , Menores , Adolescente , /efectos adversos , Niño , Ensayos Clínicos como Asunto/ética , Participación de la Comunidad , Comités de Ética en Investigación , Humanos , Consentimiento Informado de Menores , Pandemias/prevención & control
10.
Recurso de Internet en Portugués | LIS - Localizador de Información en Salud | ID: lis-47998

RESUMEN

A Plataforma Brasil é uma base nacional e unificada de registros de pesquisas envolvendo seres humanos para todo o sistema CEP/Conep. Ela permite que as pesquisas sejam acompanhadas em seus diferentes estágios - desde sua submissão até a aprovação final pelo CEP e pela Conep, quando necessário - possibilitando inclusive o acompanhamento da fase de campo, o envio de relatórios parciais e dos relatórios finais das pesquisas (quando concluídas).O sistema permite, ainda, a apresentação de documentos também em meio digital, propiciando ainda à sociedade o acesso aos dados públicos de todas as pesquisas aprovadas. Pela Internet é possível a todos os envolvidos o acesso, por meio de um ambiente compartilhado, às informações em conjunto, diminuindo de forma significativa o tempo de trâmite dos projetos em todo o sistema CEP/CONEP.


Asunto(s)
Gestión de la Información en Salud/organización & administración , Comités de Ética en Investigación/organización & administración
11.
Int. j. odontostomatol. (Print) ; 14(4): 685-693, dic. 2020. tab, graf
Artículo en Inglés | LILACS | ID: biblio-1134558

RESUMEN

ABSTRACT: The purpose of this study was to evaluate the changes in vital signs and laboratory tests of patients with odontogenic infections who required hospitalization as well as checking their effectiveness in determining the severity of the case and possible correlations with the length of stay. Patients with odontogenic infections who required hospitalization were assessed prospectively between October 2016 and April 2018. The patients were divided into two groups considered as simple (Group 1) or complex (Group 2) cases according to the length of stay. The personal data, comorbidities, signs and symptoms, vital signs and laboratory tests were analyzed. In this study, 84 cases of maxillofacial infections were detected and 50 cases of odontogenic infections were included. There were significant increases in heart rate (p = 0.012), leukocytosis (p = 0.037), neutrophilia (p = 0.021), neutrophil/lymphocyte (N/L) ratio (p = 0.044) and C-reactive protein (CRP) levels (p = 0.004) in Group 2. Additionally, there were positive correlations between the length of stay and the following variables: heart rate (p = 0.028), leukocytosis (p = 0.045), neutrophilia (p = 0.033), N/L ratio (p = 0.041) and CRP level (p = 0.003). The N/L ratio was found to have a greater value in regression analysis. It was concluded that there were significant increases in heart rate, leukocytosis, neutrophilia, N/L ratio and CRP levels for the complex cases. There were also positive correlations between the length of stay and the following variables: heart rate, leukocytosis, neutrophilia, N/L ratio and CRP level.


RESUMEN: El propósito de este estudio fue evaluar los cambios en los signos vitales y las pruebas de laboratorio de pacientes con infecciones odontogénicas que requirieron hospitalización, así como verificar su efectividad para determinar la gravedad del caso y las posibles correlaciones con la duración de la internación. Pacientes con infecciones odontogénicas que requirieron hospitalización fueron evaluados prospectivamente entre octubre de 2016 y abril de 2018. Los pacientes se dividieron en dos grupos considerados como casos simples (Grupo 1) o complejos (Grupo 2) según la duración de la internación. Se analizaron los datos personales, comorbilidades, signos y síntomas, signos vitales y pruebas de laboratorio. En este estudio, se detectaron 84 casos de infecciones maxilofaciales y se incluyeron 50 casos de infecciones odontogénicas. Hubo aumentos significativos en la frecuencia cardíaca (p = 0,012), leucocitosis (p = 0,037), neutrofilia (p = 0,021), relación neutrófilos / linfocitos (N/L) (p = 0,044) y niveles de proteína C reactiva (PCR) (p = 0,004) en el Grupo 2. Además, hubo correlaciones positivas entre la duración de la internación y las siguientes variables: frecuencia cardíaca (p = 0,028), leucocitosis (p = 0,045), neutrofilia (p = 0,033), relación N/L (p = 0,041) y nivel de PCR (p = 0,003). Se encontró que la relación N/L tenía un mayor valor en el análisis de regresión. En conclusión, hubo aumentos significativos en la frecuencia cardíaca, leucocitosis, neutrofilia, relación N/L y niveles de PCR para los casos complejos. También hubo correlaciones positivas entre la duración de la internación y las siguientes variables: frecuencia cardíaca, leucocitosis, neutrofilia, relación N/L y nivel de PCR.


Asunto(s)
Humanos , Masculino , Femenino , Adulto , Enfermedades Dentales/tratamiento farmacológico , Técnicas de Laboratorio Clínico , Signos Vitales , Infecciones/tratamiento farmacológico , Admisión del Paciente , Infecciones Bacterianas/microbiología , Proteína C-Reactiva , Factores de Riesgo , Estadísticas no Paramétricas , Comités de Ética en Investigación , Distribución por Edad y Sexo , Hospitalización , Tiempo de Internación
12.
PLoS One ; 15(12): e0241783, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33382683

RESUMEN

BACKGROUND: Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. METHODS: An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. RESULTS: Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants' rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study's scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. CONCLUSIONS: An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.


Asunto(s)
Investigación Biomédica/ética , Comités de Ética en Investigación/ética , Investigadores/psicología , Percepción Social/psicología , Adulto , Ética en Investigación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Singapur , Encuestas y Cuestionarios
13.
Rev Esp Salud Publica ; 942020 Nov 03.
Artículo en Español | MEDLINE | ID: mdl-33140740

RESUMEN

OBJECTIVE: The health crisis caused by COVID-19 required the prompt launch of research in order to generate scientific evidence pertaining to the new disease oriented to control its devastating effects and continuous spread. Therefore, it was essential to adapt the work flow of Research Ethics Committees, to prioritize and to accelerate the evaluation of projects related to this disease. METHODS: This work analyses the evaluation conducted by our Regional Ethics Committees during the initial period of the health emergency (between 13th March and 28th May 2020). RESULTS: 81 research projects were evaluated, 73 of them of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure. CONCLUSIONS: The most important research procedures to be analysed in this context are those related to the methodology and informed consent process. It is also essential to address aspects related to the privacy of personal data, and to take into account the workload of the researchers. As an improvement proposal, we think that greater collaboration between the different research teams should be encourage to obtain more robust results.


Asunto(s)
Infecciones por Coronavirus/epidemiología , Comités de Ética en Investigación , Neumonía Viral/epidemiología , Proyectos de Investigación/normas , Flujo de Trabajo , Betacoronavirus , Humanos , Consentimiento Informado , Pandemias , España
14.
Gastroenterol. hepatol. (Ed. impr.) ; 43(9): 540-550, nov. 2020.
Artículo en Español | IBECS | ID: ibc-197970

RESUMEN

Este artículo tiene como objetivo compartir nuestra experiencia con los que se plantean dedicarse a investigar. Así, se enumeran las características, cualidades o competencias que, a nuestro criterio, un buen investigador debería cumplir, y por tanto las claves que pueden ayudarle a lograr una carrera investigadora exitosa. La intención del presente artículo no es enumerar sin más una serie de recomendaciones teóricas, sino compartir algunas sugerencias personales basadas en nuestra experiencia y, por tanto, de índole eminentemente práctica. Las cualidades fundamentales que se tratarán son: Ética y honestidad. Curiosidad, pasión, entusiasmo y motivación. Persistencia, dedicación y disciplina. Ambición y liderazgo. Compromiso y responsabilidad. Organización y planificación. Adquirir conocimientos sobre metodología de la investigación. Actitud crítica y positiva ante las dificultades y el fracaso. Priorización de objetivos y gestión del tiempo. La importancia de un buen mentor. Establecimiento de una red de colaboradores y trabajo en equipo. Mantener un equilibrio entre actividad clínica e investigadora. Combinar investigación pública y privada. Equilibrio entre la vida profesional y personal. Y, finalmente, humildad, generosidad y agradecimiento. La investigación representa un pilar fundamental de la actividad médica y es evidente que la mayor calidad asistencial surge de la integración de una práctica clínica y una actividad investigadora excelentes. Con la filosofía de que la mayoría de las cualidades para desarrollar una actividad investigadora de excelencia dependen de la actitud, y pueden aprenderse, desarrollarse y mejorarse, en el presente manuscrito compartimos con el lector una serie de recomendaciones que consideramos esenciales para ser un buen investigador


This article aims to share our experience with those who consider dedicating themselves to research. In this way, the characteristics, qualities or competences that, in our opinion, a good researcher should fulfill are listed, and therefore the keys that can help you achieve a successful research career. The intention of this article is not to simply list a series of theoretical recommendations but to share some personal suggestions based on our experience and, therefore, of an eminently practical nature. The fundamental qualities to be discussed are: Ethics and honesty. Curiosity, passion, enthusiasm and motivation. Persistence, dedication and discipline. Ambition and leadership. Compromise and responsibility. Organization and planning. Acquire knowledge of research methodology. Critical and positive attitude towards difficulties and failure. Prioritization of objectives and time management. The importance of a good mentor. Establishment of a network of collaborators and teamwork. Maintain a balance between clinical and research activity. Combine public and private investigation. Balance between professional and personal life. And, finally, humility, generosity and thanks. Research represents a fundamental pillar of medical activity and it is evident that the highest quality of care arises from the integration of excellent clinical practice and research activity. With the philosophy that most of the qualities to develop an excellent research activity depend on attitude, and can be learned, developed and improved, in this manuscript we share with the reader a series of recommendations that we consider essential to be a good researcher


Asunto(s)
Humanos , Investigadores/normas , Publicaciones/normas , Ciencia , Guías como Asunto/normas , Mentores , Comités de Ética en Investigación/organización & administración , Comités de Ética en Investigación/normas , Conocimiento , Motivación
15.
J Med Internet Res ; 22(11): e22302, 2020 11 19.
Artículo en Inglés | MEDLINE | ID: mdl-33112758

RESUMEN

BACKGROUND: With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. OBJECTIVE: This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. METHODS: A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. RESULTS: The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. CONCLUSIONS: Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members' screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.


Asunto(s)
Infecciones por Coronavirus , Comités de Ética en Investigación/estadística & datos numéricos , Hospitales Universitarios , Internet , Pandemias , Neumonía Viral , Encuestas y Cuestionarios , Comunicación por Videocoferencia/estadística & datos numéricos , Infecciones por Coronavirus/epidemiología , Comités de Ética en Investigación/organización & administración , Humanos , Japón/epidemiología , Neumonía Viral/epidemiología , Comunicación por Videocoferencia/organización & administración
17.
J Korean Med Sci ; 35(36): e329, 2020 Sep 14.
Artículo en Inglés | MEDLINE | ID: mdl-32924344

RESUMEN

BACKGROUND: The number of clinical trials conducted in Korea continues to increase and an increasing proportion focus on severe and rare incurable diseases. After the start of the severe acute respiratory syndrome, coronavirus disease 2019 (COVID-19), Korea Centers for Disease Control and Prevention (KCDC) developed guidelines to prevent the spread of infection. This study evaluated the impact of COVID-19 and the KCDC guideline on the conduct of clinical research in Korea. The purpose was to develop recommendations on how to minimize the risk of infection while enabling subjects to take part in the trials if no better alternative treatment options were available. METHODS: The impact on subject's scheduled visits and major milestones of clinical trials in Korea were measured by conducting a survey among clinical project manager (CPMs) working at global clinical research organization. The policy on monitor's access to hospital and site initiation meetings was investigated through correspondence with clinical trial center of 39 hospitals. The Top 25 pharmaceutical companies' official press and public clinical trial registry database were used to analyze companies' trial strategy during the pandemic and COVID-19 clinical research status, respectively. RESULTS: Of 85 CPMs, 12% reported that trial subjects' scheduled visits had been affected in their project. Monitors' access to hospital for source data verification was restricted at all sites in February 2020. Accordingly, 43% of 105 CPMs reported that the COVID-19 epidemic had an effect on study major milestones and data cleaning and database lock accounted for > 60% of milestones affected. In addition, 87% sites advised not to have site initiation meetings and 52% pharmaceutical companies suspended recruitment or new study start-up due to the pandemic. On the other hands, the number of COVID-19 related clinical trials increased rapidly in Korea and worldwide, with investigator-initiated trials accounting for 47% and 63% of all trials locally and globally, respectively. Most trials were phase 2 and were in the recruitment stage. CONCLUSION: The COVID-19 and the KCDC guideline influenced all parties involved in clinical trials in Korea. In order to ensure the safety and well-being of trial subjects during the pandemic, new approaches are required for clinical trials to respond to the impact actively. Method of non-contact is developed to replace and supplement the face-to-face contact and alternatives to reduce the travel is introduced to decrease the risk of infection for all trial participants in whole trial process. The relevant regulations should be developed and the guidelines for foreign countries need to be adopted in accordance with the situation in Korea. COVID-19 trial is rapidly increasing worldwide and continuous support of health authorities, regulation, and facilities is required for developing the treatments with protecting all trial participants.


Asunto(s)
Betacoronavirus , Ensayos Clínicos como Asunto/métodos , Infecciones por Coronavirus/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Continuidad de la Atención al Paciente , Infecciones por Coronavirus/epidemiología , Industria Farmacéutica , Comités de Ética en Investigación , Adhesión a Directriz , Humanos , Control de Infecciones , Consentimiento Informado , Estudios Multicéntricos como Asunto , Neumonía Viral/epidemiología , Guías de Práctica Clínica como Asunto , República de Corea/epidemiología , Proyectos de Investigación , Investigadores , Viaje
18.
PLoS One ; 15(8): e0235618, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32756563

RESUMEN

BACKGROUND: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. METHODS: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. RESULTS: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical. CONCLUSION: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.


Asunto(s)
Comités de Ética en Investigación , Consentimiento Informado/ética , Comités de Ética en Investigación/ética , Ética en Investigación , Grupos Focales , Humanos , Investigación Cualitativa , Proyectos de Investigación , Investigadores/ética , Bancos de Tejidos/ética
19.
PLoS One ; 15(7): e0236079, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32735597

RESUMEN

In this preregistered study, we investigated whether the statistical power of a study is higher when researchers are asked to make a formal power analysis before collecting data. We compared the sample size descriptions from two sources: (i) a sample of pre-registrations created according to the guidelines for the Center for Open Science Preregistration Challenge (PCRs) and a sample of institutional review board (IRB) proposals from Tilburg School of Behavior and Social Sciences, which both include a recommendation to do a formal power analysis, and (ii) a sample of pre-registrations created according to the guidelines for Open Science Framework Standard Pre-Data Collection Registrations (SPRs) in which no guidance on sample size planning is given. We found that PCRs and IRBs (72%) more often included sample size decisions based on power analyses than the SPRs (45%). However, this did not result in larger planned sample sizes. The determined sample size of the PCRs and IRB proposals (Md = 90.50) was not higher than the determined sample size of the SPRs (Md = 126.00; W = 3389.5, p = 0.936). Typically, power analyses in the registrations were conducted with G*power, assuming a medium effect size, α = .05 and a power of .80. Only 20% of the power analyses contained enough information to fully reproduce the results and only 62% of these power analyses pertained to the main hypothesis test in the pre-registration. Therefore, we see ample room for improvements in the quality of the registrations and we offer several recommendations to do so.


Asunto(s)
Comités de Ética en Investigación , Tamaño de la Muestra , Estadística como Asunto/métodos
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...