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J Pediatr ; 239: 67-73.e3, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1479656


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.

COVID-19/epidemiology , Clinical Trials as Topic/organization & administration , Canada/epidemiology , Child , Europe/epidemiology , Humans
J Prev Alzheimers Dis ; 8(4): 513-519, 2021.
Article in English | MEDLINE | ID: covidwho-1308555


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.

Advisory Committees , Alzheimer Disease/drug therapy , Biomedical Research , COVID-19 , Clinical Trials as Topic , Digital Technology , Biomedical Research/organization & administration , Clinical Trials as Topic/organization & administration , European Union , Humans , United States
Clin Trials ; 18(5): 615-621, 2021 10.
Article in English | MEDLINE | ID: covidwho-1280563


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.

COVID-19 Vaccines/therapeutic use , COVID-19 , Clinical Trials as Topic/standards , Pandemics , COVID-19/prevention & control , Clinical Trials as Topic/organization & administration , Humans , Pandemics/prevention & control , State Medicine , United Kingdom/epidemiology
Contemp Clin Trials ; 106: 106438, 2021 07.
Article in English | MEDLINE | ID: covidwho-1230388


With billions of dollars in research and development (R&D) funding continuing to be invested, the novel coronavirus disease 2019 (COVID-19) has become into a singular focus for the scientific community. However, the collective response from the scientific communities have seen poor return on investment, particularly for therapeutic research for COVID-19, revealing the existing weaknesses and inefficiencies of the clinical trial enterprise. In this article, we argue for the importance of structural changes to existing research programs for clinical trials in light of the lessons learned from COVID-19.

Biomedical Research/organization & administration , COVID-19/epidemiology , COVID-19/therapy , Clinical Protocols/standards , Clinical Trials as Topic/organization & administration , Biomedical Research/economics , Biomedical Research/standards , Clinical Trials as Topic/economics , Clinical Trials as Topic/standards , Humans , SARS-CoV-2
Clin Trials ; 18(4): 511-513, 2021 08.
Article in English | MEDLINE | ID: covidwho-1195906


The proposed triple aim of health care-enhanced patient experience, improved population health, and reduced per capita costs-can be applied to clinical research. A triple aim for clinical research would (1) improve the individual research participant's experience; (2) promote the health of populations; and (3) reduce per capita costs of clinical research. Such an approach is possible by designing trials around the needs of participants rather than sites, embracing digital measures of health, and advancing decentralized studies. Recent studies, including those evaluating therapies for COVID-19, have demonstrated the value of such an approach. Accelerating the adoption of these methods can help fulfill this new triple aim of clinical research.

Clinical Trials as Topic/methods , Goals , Population Health , Research Subjects , Research Support as Topic , Biomedical Research/economics , Biomedical Research/methods , Biomedical Research/organization & administration , Clinical Trials as Topic/economics , Clinical Trials as Topic/organization & administration , Costs and Cost Analysis , Health Promotion , Humans , Patient Satisfaction , Telemedicine