RESUMEN
This Viewpoint discusses the proliferation of decentralized clinical trials during the COVID-19 pandemic and the need for rigorous studies to inform whether decentralized approaches promote or prevent access to clinical trials for people facing health disparities.
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Ensayos Clínicos como Asunto , Equidad en Salud , Humanos , Disparidades en Atención de Salud , Pandemias , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/organización & administraciónAsunto(s)
Betacoronavirus/aislamiento & purificación , Ensayos Clínicos como Asunto , Infecciones por Coronavirus , Ética en Investigación , Pandemias/prevención & control , Neumonía Viral , Investigación , COVID-19 , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/organización & administración , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/terapia , Salud Global/ética , Humanos , Evaluación de Necesidades , Selección de Paciente/ética , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Neumonía Viral/terapia , Investigación/organización & administración , Investigación/normas , SARS-CoV-2RESUMEN
Clinical trial managers play a vital role in the design and conduct of clinical trials in the UK. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the COVID-19 pandemic. Academic clinical trial units and departments are struggling to recruit trial managers to vacant positions, and multiple influences are affecting the retention of this highly skilled workforce. Without tackling this issue, we face major challenges in the delivery on the Department of Health and Social Care's Future of UK Clinical Research Delivery implementation plan. This article, led by a leading network of and for UK Trial Managers, presents some of the issues and ways in which national stakeholders may be able to address this.
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Ensayos Clínicos como Asunto , Recursos Humanos , COVID-19 , Ensayos Clínicos como Asunto/organización & administración , Humanos , Pandemias , Proyectos de InvestigaciónRESUMEN
An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.
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Ensayos Clínicos como Asunto/organización & administración , Casas de Salud/organización & administración , Anciano , COVID-19/epidemiología , Femenino , Humanos , Masculino , Pandemias , SARS-CoV-2 , Estados Unidos/epidemiologíaRESUMEN
Clinical development of vaccines in a pandemic situation should be rigorous but expedited to tackle the pandemic threat as fast as possible. We explored the effects of a novel vaccine trial strategy that actively identifies and enrolls subjects in local areas with high infection rates. In addition, we assessed the practical requirements needed for such a strategy. Clinical trial simulations were used to assess the effects of utilizing these so-called "hot spot strategy" compared to a traditional vaccine field trial. We used preset parameters of a pandemic outbreak and incorporated realistic aspects of conducting a trial in a pandemic setting. Our simulations demonstrated that incorporating a hot spot strategy shortened the duration of the vaccine trial considerably, even if only one hot spot was identified during the clinical trial. The active hot spot strategy described in this paper has clear advantages compared to a "wait-and-see" approach that is used in traditional vaccine efficacy trials. Completion of a clinical trial can be expedited by adapting to resurgences and outbreaks that will occur in a population during a pandemic. However, this approach requires a speed of response that is unusual for a traditional phase III clinical trial. Therefore, several recommendations are made to help accomplish rapid clinical trial setup in areas identified as local outbreaks. The described model and hot spot vaccination strategy can be adjusted to disease-specific transmission characteristics and could therefore be applied to any future pandemic threat.
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COVID-19/prevención & control , Ensayos Clínicos como Asunto/organización & administración , Pandemias , Eficacia de las Vacunas , Humanos , SARS-CoV-2/inmunología , Factores de TiempoAsunto(s)
Tratamiento Farmacológico de COVID-19 , Evaluación Preclínica de Medicamentos , África , Amidas , Amodiaquina , Artesunato , Sulfato de Atazanavir , COVID-19/fisiopatología , COVID-19/prevención & control , COVID-19/transmisión , Vacunas contra la COVID-19/provisión & distribución , Carbamatos , Ensayos Clínicos como Asunto/organización & administración , Citidina/análogos & derivados , Citidina/economía , Citidina/uso terapéutico , Aprobación de Drogas , Reposicionamiento de Medicamentos , Quimioterapia Combinada , Humanos , Hidroxilaminas/economía , Hidroxilaminas/uso terapéutico , Imidazoles , Ivermectina , Naftiridinas , Nitrocompuestos , Pregnenodionas , Pirazinas , Pirrolidinas , Ritonavir , Tamaño de la Muestra , Tiazoles , Valina/análogos & derivados , Organización Mundial de la SaludRESUMEN
OBJECTIVE: To capture the early effects of the coronavirus disease 2019 (COVID-19) pandemic on pediatric clinical research. STUDY DESIGN: Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the interpretation of results through pan-European group discussions. Based on first detection dates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), countries formed 1 early detecting and 1 late detecting cluster. We tested the hypothesis that this clustering influenced clinical research. RESULTS: Research sites were first impacted by the pandemic in mid-March 2020 (March 16 ± 10 days, the same date as lockdown initiation; P = .99). From first impact up until early June, site initiation and feasibility analysis processes were affected for >50% of the sites. Staff were redirected to COVID-19 research for 44% of the sites, and 75.5% of sites were involved in pediatric COVID-19 research (only 6.3% reported COVID-19 cases in their other pediatric trials). Mitigation strategies were used differently between the early and late detecting country clusters and between countries with and without a pediatric COVID-19 research taskforce. Positive effects include the development of teleworking capacities. CONCLUSIONS: Through this collaborative effort from pediatric research networks, we found that pediatric trials were affected and conducted with a range of unequally applied mitigations across countries during the pandemic. The global impact might be greater than captured. In a context where clinical research is increasingly multinational, this report reveals the importance of collaboration between national networks.
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COVID-19/epidemiología , Ensayos Clínicos como Asunto/organización & administración , Canadá/epidemiología , Niño , Europa (Continente)/epidemiología , HumanosAsunto(s)
Vacunas contra la COVID-19/genética , Vacunas contra la COVID-19/provisión & distribución , COVID-19/inmunología , COVID-19/virología , Inmunogenicidad Vacunal/inmunología , SARS-CoV-2/genética , SARS-CoV-2/inmunología , Vacunas contra la COVID-19/inmunología , Ensayos Clínicos como Asunto/organización & administración , Humanos , Organización Mundial de la SaludAsunto(s)
Investigación Biomédica/organización & administración , Ensayos Clínicos como Asunto/organización & administración , Infecciones por Coronavirus/epidemiología , Industria Farmacéutica/organización & administración , National Institutes of Health (U.S.)/organización & administración , Osteocondrodisplasias/tratamiento farmacológico , Neumonía Viral/epidemiología , Animales , COVID-19 , Vacunas contra la COVID-19 , Niño , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/prevención & control , Aprobación de Drogas/organización & administración , Humanos , Masculino , Osteocondrodisplasias/psicología , Pandemias , Estrés Psicológico , Incertidumbre , Estados Unidos , Vacunas Virales/inmunologíaAsunto(s)
Betacoronavirus/efectos de los fármacos , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/organización & administración , Infecciones por Coronavirus/tratamiento farmacológico , Industria Farmacéutica/métodos , Hidroxicloroquina/farmacología , Hidroxicloroquina/uso terapéutico , Neumonía Viral/tratamiento farmacológico , COVID-19 , Infecciones por Coronavirus/virología , Desarrollo de Medicamentos/métodos , Desarrollo de Medicamentos/organización & administración , Desarrollo de Medicamentos/tendencias , Industria Farmacéutica/organización & administración , Humanos , Pandemias , Selección de Paciente , Neumonía Viral/virología , SARS-CoV-2 , Factores de Tiempo , Estados Unidos , United States Food and Drug Administration/legislación & jurisprudenciaRESUMEN
The COVID-19 pandemic brought about major changes in cancer clinical trials. In its aftermath, the community has an opportunity to incorporate some of these changes as part of the future of trial conduct to make it more patient centered.
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COVID-19 , Ensayos Clínicos como Asunto , Neoplasias , Academias e Institutos , COVID-19/prevención & control , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Ensayos Clínicos como Asunto/organización & administración , Industria Farmacéutica , Agencias Gubernamentales , Humanos , Control de Infecciones , National Cancer Institute (U.S.)/organización & administración , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Antivirales/uso terapéutico , Vacunas contra la COVID-19 , COVID-19 , Ensayos Clínicos como Asunto/organización & administración , Experimentación Humana/normas , SARS-CoV-2 , COVID-19/inmunología , COVID-19/prevención & control , COVID-19/terapia , Ensayos Clínicos como Asunto/ética , HumanosRESUMEN
The 2020 COVID-19 pandemic has disrupted Alzheimer's disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer's Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.
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Comités Consultivos , Enfermedad de Alzheimer/tratamiento farmacológico , Investigación Biomédica , COVID-19 , Ensayos Clínicos como Asunto , Tecnología Digital , Investigación Biomédica/organización & administración , Ensayos Clínicos como Asunto/organización & administración , Unión Europea , Humanos , Estados UnidosAsunto(s)
COVID-19 , Ensayos Clínicos como Asunto , Terminación Anticipada de los Ensayos Clínicos , Oncología Médica/métodos , Neoplasias/terapia , Investigación Biomédica/organización & administración , Investigación Biomédica/tendencias , COVID-19/epidemiología , COVID-19/prevención & control , Ensayos Clínicos como Asunto/clasificación , Ensayos Clínicos como Asunto/organización & administración , Ensayos Clínicos como Asunto/estadística & datos numéricos , Control de Enfermedades Transmisibles/métodos , Terminación Anticipada de los Ensayos Clínicos/efectos adversos , Terminación Anticipada de los Ensayos Clínicos/estadística & datos numéricos , Predicción , Humanos , Estudios Observacionales como Asunto/estadística & datos numéricos , SARS-CoV-2RESUMEN
The COVID-19 pandemic has resulted in unprecedented challenges for healthcare systems worldwide. It has also stimulated research in a wide range of areas including rapid diagnostics, novel therapeutics, use of technology to track patients and vaccine development. Here, we describe our experience of rapidly setting up and delivering a novel COVID-19 vaccine trial, using clinical and research staff and facilities in three National Health Service Trusts in Cambridgeshire, United Kingdom. We encountered and overcame a number of challenges including differences in organisational structures, research facilities available, staff experience and skills, information technology and communications infrastructure, and research training and assessment procedures. We overcame these by setting up a project team that included key members from all three organisations that met at least daily by teleconference. This group together worked to identify the best practices and procedures and to harmonise and cascade these to the wider trial team. This enabled us to set up the trial within 25 days and to recruit and vaccinate the participants within a further 23 days. The lessons learned from our experiences could be used to inform the conduct of clinical trials during a future infectious disease pandemic or public health emergency.