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3.
Vaccine ; 38(46): 7213-7216, 2020 10 27.
Artigo em Inglês | MEDLINE | ID: mdl-33012602

RESUMO

To rapidly evaluate the safety and efficacy of COVID-19 vaccine candidates, prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration. Mathematical and statistical forecast models can inform the process of site selection, integrating available data sources and facilitating comparisons across locations. We recommend the use of ensemble forecast modeling - combining projections from independent modeling groups - to guide investigators identifying suitable sites for COVID-19 vaccine efficacy trials. We describe an appropriate structure for this process, including minimum requirements, suggested output, and a user-friendly tool for displaying results. Importantly, we advise that this process be repeated regularly throughout the trial, to inform decisions about enrolling new participants at existing sites with waning incidence versus adding entirely new sites. These types of data-driven models can support the implementation of flexible efficacy trials tailored to the outbreak setting.


Assuntos
Betacoronavirus/imunologia , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/efeitos adversos , Vacinas Virais/imunologia , Infecções por Coronavirus/imunologia , Previsões/métodos , Humanos , Modelos Teóricos
4.
Oncology (Williston Park) ; 34(10): 432-441, 2020 10 09.
Artigo em Inglês | MEDLINE | ID: mdl-33058111

RESUMO

Worldwide incidence and mortality due to the coronavirus disease 2019 (COVID-19) pandemic is greatest in the United States, with the initial epicenter in New York. In Nassau County, New York, where we practice, our institution has had more than 2500 cases and has discharged from the hospital more than 1000 patients. As many academic and private institutions have swiftly shifted their clinical and research priorities to address the pandemic, data are emerging regarding both the impact of malignancy on COVID-19 outcomes as well as the challenges faced in assuring that cancer care remains unimpeded. Of concern, recent studies of cancer patients primarily in China and Italy have suggested that advanced malignancy is associated with increased susceptibility to severe COVID-19 infection. At present, more than 500 clinical trials are underway investigating the pathogenesis and treatment of COVID-19, including expanded use of oncology drugs, such as small molecular inhibitors of cytokine pathways. Here, we begin by reviewing the latest understanding of COVID-19 pathophysiology and then focus our attention on the impact of this virus on hematologic and oncologic practice. Finally, we highlight ongoing investigational treatment approaches that are so relevant to the care of oncology patients during this extraordinary pandemic.


Assuntos
Antineoplásicos , Betacoronavirus , Infecções por Coronavirus , Assistência à Saúde , Controle de Infecções , Oncologia , Neoplasias , Pandemias , Pneumonia Viral , Antineoplásicos/classificação , Antineoplásicos/farmacologia , Betacoronavirus/efeitos dos fármacos , Betacoronavirus/patogenicidade , Betacoronavirus/fisiologia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Assistência à Saúde/organização & administração , Assistência à Saúde/normas , Assistência à Saúde/tendências , Drogas em Investigação/farmacologia , Humanos , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Oncologia/métodos , Oncologia/normas , Neoplasias/epidemiologia , Neoplasias/terapia , New York/epidemiologia , Pandemias/prevenção & controle , Assistência ao Paciente/métodos , Assistência ao Paciente/normas , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Risco Ajustado/métodos , Medição de Risco
5.
Medicine (Baltimore) ; 99(43): e22840, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-33120812

RESUMO

Up-to-date information on the current progress made in the research and development to control the global COVID-19 pandemic is important. The study aimed to analyze the clinical trial characteristics and vaccine development progress of the new Coronavirus Disease 2019 (COVID-19) registered with the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP).A comprehensive search of COVID-19 clinical trials since the establishment of the ICTRP to June 11, 2020, was conducted to record and analyze relevant characteristics. Chi-Squared test was used to compare the statistical differences between different research types, interventions, and sources.A total of 3282 COVID-19 clinical trials in 17 clinical trial registration centers were registered with the WHO ICTRP. The main research sources for the present study were ClinicalTrials.gov and ChiCTR. There were significant differences in the parameters of study location (P = .000), number of participants (P = .000), study duration (P = .001), research stage (P = .000), randomization procedure (P = .000), and blinding method (P = .000) between the 2 registration sources. There were significant differences in all the parameters between different kinds of intervention methods. Hydroxychloroquine, plasma therapy, and Xiyanping injection were the high-frequency research drugs used. Ten different vaccine studies were registered under phases I-II.Amongst the studies researched, heterogeneity existed for various parameters. Differences in the type of study, interventions, and registration sources of the studies led to significant differences in certain parameters of the COVID-19 clinical trials. The statistics of high-frequency drugs and the progress of vaccine trials may provide an informative reference for the prevention and control of COVID-19.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Sistema de Registros , Projetos de Pesquisa , Organização Mundial da Saúde , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias , Melhoria de Qualidade , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos , Vacinas Virais
6.
PLoS One ; 15(9): e0239486, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32946505

RESUMO

Biomarkers can be used to enrich a clinical trial for patients at higher risk for an outcome, a strategy termed "prognostic enrichment." Methodology is needed to evaluate biomarkers for prognostic enrichment of trials with time-to-event endpoints such as survival. Key considerations when considering prognostic enrichment include: clinical trial sample size; the number of patients one must screen to enroll the trial; and total patient screening costs and total per-patient trial costs. The Biomarker Prognostic Enrichment Tool for Survival Outcomes (BioPETsurv) is a suite of methods for estimating these elements to evaluate a prognostic enrichment biomarker and/or plan a prognostically enriched clinical trial with a time-to-event primary endpoint. BioPETsurv allows investigators to analyze data on a candidate biomarker and potentially censored survival times. Alternatively, BioPETsurv can simulate data to match a particular clinical setting. BioPETsurv's data simulator enables investigators to explore the potential utility of a prognostic enrichment biomarker for their clinical setting. Results demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics such as reducing sample size or trial costs. In addition to the quantitative analysis provided by BioPETsurv, investigators should consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria. BioPETsurv is freely available as a package for the R statistical computing platform, and as a webtool at www.prognosticenrichment.com/surv.


Assuntos
Biomarcadores/análise , Ensaios Clínicos como Assunto/métodos , Software , Área Sob a Curva , Ensaios Clínicos como Assunto/estatística & dados numéricos , Simulação por Computador , Humanos , Estimativa de Kaplan-Meier , Seleção de Pacientes , Prognóstico , Tamanho da Amostra
7.
Nat Med ; 26(9): 1351-1363, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32908284

RESUMO

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.


Assuntos
Inteligência Artificial , Ensaios Clínicos como Assunto/métodos , Projetos de Pesquisa/normas , Humanos
10.
J Alzheimers Dis ; 77(4): 1805-1813, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32986671

RESUMO

BACKGROUND: The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. OBJECTIVE: To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. METHODS: We describe participants' clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. RESULTS: A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. DISCUSSION: The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.


Assuntos
Doença de Alzheimer/terapia , Ensaios Clínicos como Assunto , Infecções por Coronavirus , Pandemias , Assistência ao Paciente , Pneumonia Viral , Idoso , Instituições de Assistência Ambulatorial , Betacoronavirus , Técnicas de Laboratório Clínico , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Feminino , Humanos , Masculino , Pandemias/prevenção & controle , Assistência ao Paciente/métodos , Assistência ao Paciente/tendências , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Espanha/epidemiologia , Telemedicina/métodos , Terapias em Estudo/métodos
11.
Zhejiang Da Xue Xue Bao Yi Xue Ban ; 49(4): 531-536, 2020 Aug 25.
Artigo em Chinês | MEDLINE | ID: mdl-32985168

RESUMO

Clinical trial management system is independently developed by our hospital, which basically realized the whole process management and data collection of clinical trials. Based on the platform, the functional architecture of data remote monitoring and auditing was established. By desensitizing and encrypting of data, the project and subject hologram were visualized to facilitate to review of data. The data remote monitoring and auditing cloud platform adopts the B/S architecture pattern. Users register to apply for an account through the cloud platform, and access to the account via HTTPS security protocol. The authorized users were able to view the relevant items online to ensure the secure data transmission and easy operating. The electronic management of data is the direction of future efforts. By compliance with laws and regulations, the remote monitoring/auditing can be realized, and the data security and personal privacy can be ensured with the application of information technology. In this paper, the feasibility of remote monitoring/auditing mode is explored, specific technical schemes and system functions are suggested, and the realization scenarios are conceived in case of major public health emergencies.


Assuntos
Ensaios Clínicos como Assunto , Auditoria Administrativa , Consulta Remota , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Segurança Computacional
12.
J Korean Med Sci ; 35(36): e329, 2020 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-32924344

RESUMO

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.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Continuidade da Assistência ao Paciente , Infecções por Coronavirus/epidemiologia , Indústria Farmacêutica , Comitês de Ética em Pesquisa , Fidelidade a Diretrizes , Humanos , Controle de Infecções , Consentimento Livre e Esclarecido , Estudos Multicêntricos como Assunto , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , República da Coreia/epidemiologia , Projetos de Pesquisa , Pesquisadores , Viagem
14.
Trials ; 21(1): 784, 2020 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-32917258

RESUMO

The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial processes, working closely with other members of the research team. This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers' Network (UKTMN), a national network of trial management professionals managing non-commercial trials.In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collection and management and intervention delivery. In many cases, recruitment has been paused whilst mitigations have been put in place to continue data collection. Innovative solutions have been implemented to ensure we continue, where possible, to deliver high-quality clinical trials. Technology has provided many solutions to these challenges, and trial managers have adapted to new ways of working whilst continuing to deliver their clinical trials. Trial management groups are now faced with new uncertainties around re-starting clinical trials, and it is unclear currently how this will go, though working together with sponsors, funders and site teams is clearly a priority.Clinical trial teams have worked together to ensure their trials have adapted quickly whilst ensuring participant safety is given utmost importance. There are clear examples where the trial community have come together to share experiences and expertise, and this should continue in the future to ensure the innovative practices developed become embedded in the design and conduct of clinical trials in the future.


Assuntos
Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Projetos de Pesquisa , Betacoronavirus/patogenicidade , Comitês de Monitoramento de Dados de Ensaios Clínicos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Confiabilidade dos Dados , Coleta de Dados , Interações Hospedeiro-Patógeno , Humanos , Segurança do Paciente , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Medição de Risco , Fatores de Risco , Fatores de Tempo , Fluxo de Trabalho
15.
Expert Rev Clin Pharmacol ; 13(9): 1067-1072, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32795214

RESUMO

BACKGROUND: The different features between non-industry-sponsored medicine trials conducted in Europe and the USA to treat COVID-19 patients registered in the first trimester of the pandemic are unknown. METHODS: A search was conducted on four databases looking for ongoing medicine randomized controlled trials (RCTs) and non-RCTs registered current through April 25, 2020. All trials assessing medicines on prophylaxis, special populations, assessing non-medicines and convalescent plasma, were excluded. Of each trial, medicines assessed, design, sample size, registration date, study start and study completion dates, and type of patients were registered. RESULTS: 106 trials were identified, 62 in Europe and 46 in the USA ─with two conducted in both regions. In Europe, 90% were on hospitalized patients, and 70% in the USA (p<0.01). Mean of the estimated time to completion were 7.8 and 13.6 (p<0.001) months for European and USA trials . Multicenter trials were more frequent in Europe (63%) than in the USA (41%) (p=0.031). Masked RCTs were more frequently run in the USA than in Europe (p<0.001). RCTs on hospitalized patients were more commonly conducted in Europe (91%) than in the USA (65%) (p<0.01). CONCLUSIONS: Features of early registered COVID-19 RCTs with medicines in Europe and America had remarkable differences.


Assuntos
Antivirais/uso terapêutico , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Projetos de Pesquisa , Europa (Continente) , Humanos , Pandemias , Estados Unidos
18.
Cancer Treat Rev ; 89: 102061, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32738737

RESUMO

Renal cell cancer (RCC) is the third most diagnosed genitourinary malignancy in the world. Nearly a half of the diagnoses and 60% of related deaths occur in low-middle income countries (LMs), where prognosis is generally poor. We conducted a systematic research of ClinicalTrials.gov, searching RCC ongoing studies for adult patients. We included 205 trials in the final analysis. The enrolling centers were mainly distributed in high-income settings (88.9%). We estimated 94.6% of the trial population was enrolled in only five countries and none in LMs. Clinical drug development for RCC is driven by early phase studies, mainly assessing small molecule tyrosine kinase inhibitors and immunotherapy or the combination. Sixty percent of the trials were industry sponsored. Only a minority of the trials were in the early setting of care, adjuvant or neoadjuvant therapy. Disparities in drug development in LMs mirror a common underestimation of the value of research among the national priorities in cancer health planning, resulting in poor ethnic diversity and inclusiveness. This commonly results in incomplete knowledge of activity and safety of medicines across different ethnic groups, with consequences on priorities for cancer interventions and estimates of benefit in LMs patients. The use of RCC as a case study for inclusiveness suggests poor inclusion of non- Caucasian populations in the trials, especially trials testing new immunotherapy and targeted agents where RCC drug development is more pronounced, resulting in issues of generalizability in other ethnic groups when these compounds are approved with no ethnic restrictions or specifications.


Assuntos
Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Neoplasias Renais/tratamento farmacológico , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Desenvolvimento de Medicamentos/métodos , Humanos , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Medicine (Baltimore) ; 99(34): e21591, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846767

RESUMO

BACKGROUND: Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common, chronic sleep disease. As the incidence of OSAHS increases, it has seriously threatened people's health. There have been an increasing number of clinical trials of OSAHS in recent years. However, the clinical trials of OSAHS have heterogeneous outcomes, surrogate outcomes, subjective outcomes, and composite outcomes, as well as the lack of endpoints or patient perspectives. The best method is to develop a core outcomes sets (COSs) for OSAHS's clinical trials. METHODS: The development of COSs of OSAHS will include 5 stages: RESULTS:: The results of our study will be published in a peer-reviewed journal. DISCUSSION: The development of the COSs of OSAHS will improve the design and operation of OSAHS clinical trials to conform to international standards and ensure the credibility of the outcomes. In addition, this study will involve different stakeholder groups to help ensure that the developed COSs will be suitable and well accepted. TRIAL REGISTRATION NUMBER: 1544.


Assuntos
Ensaios Clínicos como Assunto/métodos , Apneia Obstrutiva do Sono/terapia , Humanos , Resultado do Tratamento
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