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1.
Trials ; 22(1): 153, 2021 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-33602275

RESUMO

BACKGROUND: The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is not the norm, but the unprecedented pandemic caused by SARS-CoV-2 may serve as an impetus for greater data sharing. We sought to assess the data sharing intentions of interventional COVID-19 trials as declared in trial registrations and publications. METHODS: We searched ClinicalTrials.gov and PubMed for COVID-19 interventional trials. We analyzed responses to ClinicalTrials.gov fields regarding intent to share individual participant level data and analyzed the data sharing statements in eligible publications. RESULTS: Nine hundred twenty-four trial registrations were analyzed. 15.7% were willing to share, of which 38.6% were willing to share immediately upon publication of results. 47.6% declared they were not willing to share. Twenty-eight publications were analyzed representing 26 unique COVID-19 trials. Only seven publications contained data sharing statements; six indicated a willingness to share data whereas one indicated that data was not available for sharing. CONCLUSIONS: At a time of pressing need for researchers to work together to combat a global pandemic, intent to share individual participant-level data from COVID-19 interventional trials is limited.


Assuntos
/terapia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Disseminação de Informação , Publicações/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , /epidemiologia , Humanos , Intenção , Pandemias/prevenção & controle
2.
Theranostics ; 11(4): 1690-1702, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33408775

RESUMO

The global outbreak of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) highlighted a requirement for two pronged clinical interventions such as development of effective vaccines and acute therapeutic options for medium-to-severe stages of "coronavirus disease 2019" (COVID-19). Effective vaccines, if successfully developed, have been emphasized to become the most effective strategy in the global fight against the COVID-19 pandemic. Basic research advances in biotechnology and genetic engineering have already provided excellent progress and groundbreaking new discoveries in the field of the coronavirus biology and its epidemiology. In particular, for the vaccine development the advances in characterization of a capsid structure and identification of its antigens that can become targets for new vaccines. The development of the experimental vaccines requires a plethora of molecular techniques as well as strict compliance with safety procedures. The research and clinical data integrity, cross-validation of the results, and appropriated studies from the perspective of efficacy and potently side effects have recently become a hotly discussed topic. In this review, we present an update on latest advances and progress in an ongoing race to develop 52 different vaccines against SARS-CoV-2. Our analysis is focused on registered clinical trials (current as of November 04, 2020) that fulfill the international safety and efficacy criteria in the vaccine development. The requirements as well as benefits and risks of diverse types of SARS-CoV-2 vaccines are discussed including those containing whole-virus and live-attenuated vaccines, subunit vaccines, mRNA vaccines, DNA vaccines, live vector vaccines, and also plant-based vaccine formulation containing coronavirus-like particle (VLP). The challenges associated with the vaccine development as well as its distribution, safety and long-term effectiveness have also been highlighted and discussed.


Assuntos
/epidemiologia , Desenvolvimento de Medicamentos/tendências , Pandemias/prevenção & controle , /imunologia , Antígenos Virais/genética , Antígenos Virais/imunologia , /transmissão , Ensaios Clínicos como Assunto/estatística & dados numéricos , Aprovação de Drogas , Desenvolvimento de Medicamentos/estatística & dados numéricos , Humanos , Segurança do Paciente , Fatores de Tempo , Resultado do Tratamento , Proteínas Estruturais Virais/genética , Proteínas Estruturais Virais/imunologia
7.
Medwave ; 20(9): e8051, 2020 Oct 26.
Artigo em Espanhol, Inglês | MEDLINE | ID: mdl-33141813

RESUMO

Introduction: The World Health Organization declared the disease caused by the novel coronavirus (SARS-CoV-2), a pandemic on March 11, 2020. Several studies have been proposed and started since then, mainly covering prevention, diagnosis, management, and treatment. Objective: To identify and categorize all intervention studies up to the end of May related to SARS-CoV-2 infection, according to population and geo-graphical location (emphasis in Latin America) and to verify if there is any correlation according to purpose, phase, and recruitment status. Methods: One thousand six hundred seventy-two trials were selected from 1705 until May 24 on the World Health Organization clinical trials platform related to COVID-19. Jupyter and Python tools were used for data processing and cleaning. Results: One thousand six hundred seventy-two intervention studies related to SARS-CoV-2 infection were found. China, The United States, Iran, France, and Spain are the countries participating in the largest number of studies, while only 4,1% are from Latin America (mostly Brazilian). 28 studies are focusing only on older adults, and ten studies are based exclusively on populations under 19 years of age. Conclusion: The worldwide interest in this new disease is reflected in the increasing number of intervention studies that are being carried out to date. How-ever, the studies analyzed do not cover the most vulnerable age groups proportionally and do not have equitable participation of all the coun-tries. In Latin America, this problem is exacerbated by the region's social, economic, and political limitations. Because it is an emerging disease, there is still not enough information to establish strong correlations between the analyzed variables, and the standardization of protocols is not yet definite because most of the studies are in progress.


Assuntos
Betacoronavirus/isolamento & purificação , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Seleção de Pacientes , Pneumonia Viral/diagnóstico , Pneumonia Viral/prevenção & controle
8.
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
9.
Medwave ; 20(9)30-10-2020.
Artigo em Inglês, Espanhol | LILACS | ID: biblio-1141139

RESUMO

Introducción La infección por SARS CoV-2 fue declarada pandemia el 11 de marzo de 2020. Desde entonces, se han propuesto e iniciado numerosos estudios, cuyo propósito incluye prevención, diagnóstico, manejo y tratamiento de esta nueva enfermedad. Objetivo Identificar y categorizar los estudios intervencionales hasta mayo de 20202 relacionados con la infección por SARS-CoV-2, de acuerdo con población y ubicación geográfica (con énfasis en Latinoamérica) y comprobar si existe correlación según el propósito, fase y estado de reclutamiento de los mismos. Metodología Se seleccionaron 1672 de los 1705 estudios disponibles en la plataforma de ensayos clínicos de la Organización Mundial de la Salud (OMS) relacionados con COVID-19. Se utilizaron las herramientas Jupyter y Python para el procesamiento y depuración de datos. Resultados Se encontraron 1672 estudios de tipo intervencional relacionados con la infección por SARS-CoV-2. China, Estados Unidos, Irán, Francia y España son los países que participan en mayor cantidad de estudios, mientras que solamente 4,1% proviene de América Latina (mayoritaria-mente brasileños). Las investigaciones que se centran únicamente en adultos mayores son 28, y solamente 10 estudios se basan exclusivamente en población menor de 19 años. Conclusión El interés mundial por esta nueva enfermedad se ve reflejado en la cantidad creciente de estudios intervencionales que se han realizado hasta la fecha. Sin embargo, los estudios analizados no abarcan proporcionalmente los grupos etarios más vulnerables, y no cuentan con una participa-ción equitativa de los países del orbe. En el caso de América Latina se agudiza esta problemática debido a las limitaciones sociales, económicas y políticas de la región. Debido a que es una enfermedad emergente, aún no existe suficiente información para poder establecer correlaciones contundentes entre las variables estudiadas. La estandarización definitiva de protocolos resulta prematura, ya que la mayoría de los estudios se encuentran en curso.


Introduction The World Health Organization declared the disease caused by the novel coronavirus (SARS-CoV-2), a pandemic on March 11, 2020. Several studies have been proposed and started since then, mainly covering prevention, diagnosis, management, and treatment. Objective To identify and categorize all intervention studies up to the end of May related to SARS-CoV-2 infection, according to population and geo-graphical location (emphasis in Latin America) and to verify if there is any correlation according to purpose, phase, and recruitment status. Methods One thousand six hundred seventy-two trials were selected from 1705 until May 24 on the World Health Organization clinical trials platform related to COVID-19. Jupyter and Python tools were used for data processing and cleaning. Results One thousand six hundred seventy-two intervention studies related to SARS-CoV-2 infection were found. China, The United States, Iran, France, and Spain are the countries participating in the largest number of studies, while only 4,1% are from Latin America (mostly Brazilian). 28 studies are focusing only on older adults, and ten studies are based exclusively on populations under 19 years of age. Conclusion The worldwide interest in this new disease is reflected in the increasing number of intervention studies that are being carried out to date. How-ever, the studies analyzed do not cover the most vulnerable age groups proportionally and do not have equitable participation of all the coun-tries. In Latin America, this problem is exacerbated by the region's social, economic, and political limitations. Because it is an emerging disease, there is still not enough information to establish strong correlations between the analyzed variables, and the standardization of protocols is not yet definite because most of the studies are in progress.


Assuntos
Humanos , Pneumonia Viral/terapia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/terapia , Betacoronavirus/isolamento & purificação , Pneumonia Viral/diagnóstico , Pneumonia Viral/prevenção & controle , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/prevenção & controle , Seleção de Pacientes , Pandemias/prevenção & controle
10.
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
13.
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
15.
PLoS One ; 15(8): e0236392, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32780735

RESUMO

In clinical trials, animal and cell line models are often used to evaluate the potential toxic effects of a novel compound or candidate drug before progressing to human trials. However, relating the results of animal and in vitro model exposures to relevant clinical outcomes in the human in vivo system still proves challenging, relying on often putative orthologs. In recent years, multiple studies have demonstrated that the repeated dose rodent bioassay, the current gold standard in the field, lacks sufficient sensitivity and specificity in predicting toxic effects of pharmaceuticals in humans. In this study, we evaluate the potential of deep learning techniques to translate the pattern of gene expression measured following an exposure in rodents to humans, circumventing the current reliance on orthologs, and also from in vitro to in vivo experimental designs. Of the applied deep learning architectures applied in this study the convolutional neural network (CNN) and a deep artificial neural network with bottleneck architecture significantly outperform classical machine learning techniques in predicting the time series of gene expression in primary human hepatocytes given a measured time series of gene expression from primary rat hepatocytes following exposure in vitro to a previously unseen compound across multiple toxicologically relevant gene sets. With a reduction in average mean absolute error across 76 genes that have been shown to be predictive for identifying carcinogenicity from 0.0172 for a random regression forest to 0.0166 for the CNN model (p < 0.05). These deep learning architecture also perform well when applied to predict time series of in vivo gene expression given measured time series of in vitro gene expression for rats.


Assuntos
Aprendizado Profundo , Regulação da Expressão Gênica/efeitos dos fármacos , Aprendizado de Máquina , Algoritmos , Animais , Ensaios Clínicos como Assunto/estatística & dados numéricos , Regulação da Expressão Gênica/genética , Hepatócitos/efeitos dos fármacos , Humanos , Redes Neurais de Computação , Ratos
16.
Medicina (Kaunas) ; 56(6)2020 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-32604775

RESUMO

Background and objective: Despite medical advances, we are facing the unprecedented disaster of the coronavirus disease 2019 (COVID-19) pandemic without available treatments and effective vaccines. As the COVID-19 pandemic has approached its culmination, desperate efforts have been made to seek proper treatments and response strategies, and the number of clinical trials has been rapidly increasing. In this time of the pandemic, it is believed that learning lessons from it would be meaningful in preparing for future pandemics. Thus, this study aims at providing a comprehensive landscape of COVID-19 related clinical trials based on the ClinicalTrials.gov database. Materials and methods: Up to 30 March 2020, we identified a total of 147 eligible clinical trials and reviewed the overview of the studies. Results: Until then, the most clinical trials were set up in China. Treatment approaches are the most frequent purpose of the registered studies. Chloroquine, interferon, and antiviral agents such as remdesivir, lopinavir, and ritonavir are agents under investigation in these trials. Conclusions: In this study, we introduced the promising therapeutic options that many researchers and clinicians are interested in, and to address the hidden issues behind clinical trials in this COVID-19 pandemic.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Bases de Dados Factuais , Humanos , Pandemias
17.
Emerg Microbes Infect ; 9(1): 1695-1701, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32615862

RESUMO

The COVID-19 pandemic has caused a global public health crisis. There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the COVID-19 pandemic. The Chinese scientists supported by private and government resources have adopted extensive efforts to identify effective drugs against the virus. To date, a large number of clinical trials addressing various aspects of COVID19 have been registered in the Chinese Clinical Trial Registry (ChiCTR), including more than 200 interventional studies. Under such an urgent circumstance, the scope and quality of these clinical studies vary significantly. Hence, this review aims to make a comprehensive analysis on the profiles of COVID-19 clinical trials registered in the ChiCTR, including a wide range of characteristics. Our findings will provide a useful summary on these clinical studies since most of these studies will encounter major challenges from the design to completion. It will be a long road for the outcomes of these studies to be published and international collaboration will help the ultimate goals of developing new vaccines and anti-viral drugs.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Sistema de Registros , China , Humanos , Medicina Tradicional Chinesa , Pandemias , Projetos de Pesquisa
18.
BMJ Open ; 10(6): e039978, 2020 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-32518212

RESUMO

OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO's International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers. MAIN OUTCOMES: Trial intervention, sponsorship, critical design elements and specified outcomes RESULTS: Overall, 201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020. CONCLUSIONS: While accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.


Assuntos
Antimaláricos/farmacologia , Antineoplásicos/farmacologia , Antivirais/farmacologia , Ensaios Clínicos como Assunto , Infecções por Coronavirus , Imunização Passiva/métodos , Imunossupressores/farmacologia , Pandemias , Plasma/imunologia , Pneumonia Viral , Betacoronavirus/isolamento & purificação , Ensaios Clínicos como Assunto/classificação , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Estudos Transversais , Humanos , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Sistema de Registros/estatística & dados numéricos , Terapias em Estudo/métodos , Terapias em Estudo/estatística & dados numéricos
19.
PLoS One ; 15(6): e0233996, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32502181

RESUMO

While the epidemiologic burden of mental health disorders in the United States has been well described over the past decade, we know relatively little about trends in how these disorders are being studied through clinical research. We examined all US interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 to identify trends in trial characteristics, comparisons with non-mental health trials, and trial attributes associated with discontinuation and results reporting. International data were excluded to minimize potential confounding. Over this period, mental health and non-mental health trials grew at similar rates, though Industry and US government-funded trials declined and academic medical center/hospital/other (AMC/Hosp/Oth) funded trials grew faster in mental health research. The proportion of trials with safeguards against bias, including blinding and oversight by data monitoring committees (DMCs), decreased. This occurred during growth in the proportion of trials studying behavioral and non-pharmacological interventions, which often cannot be blinded and do not require DMC oversight. There was concurrent decline in pharmaceutical trials. There was significant growth in trials studying Non-DSM (Diagnostic and Statistical Manual-5) conditions (e.g. suicidality and wellness), as well as substance use, anxiety, and neurocognitive disorders. One in 12 trials was discontinued. Trial discontinuation was associated with industry and AMC/Hosp/Oth funders, pharmaceutical interventions, and lack of DMC oversight. Only 29.9% of completed trials reported results to the registry. Decreased results reporting was associated with behavioral interventions, phase 1 trials, and industry and AMC/Hosp/Oth funders. The main implications of these data are that funding is shifting away from traditional government and industry sources, there is increasing interest in non-pharmacological treatments and Non-DSM conditions, and there are changing norms in trial design characteristics regarding safeguards against bias. These trends can guide researchers and funding bodies when considering the trajectory of future mental health research.


Assuntos
Pesquisa Biomédica/tendências , Ensaios Clínicos como Assunto/estatística & dados numéricos , Transtornos Mentais/terapia , Saúde Mental/tendências , Sistema de Registros/estatística & dados numéricos , Viés , Pesquisa Biomédica/estatística & dados numéricos , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Ensaios Clínicos como Assunto/normas , Humanos , Saúde Mental/estatística & dados numéricos , Seleção de Pacientes , Projetos de Pesquisa/normas , Estados Unidos
20.
J Clin Epidemiol ; 125: 170-178, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32526460

RESUMO

BACKGROUND AND OBJECTIVE: There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the coronavirus disease 2019 (COVID-19) pandemic. The number of registered trials related to COVID-19 is increasing by the day. The objective of this study was to describe the characteristics of the currently registered interventional clinical trials related to COVID-19. METHODS: We searched the World Health Organization's International Clinical Trials Registry Platform on May 15th, 2020. We included any entry that is related to COVID-19. We abstracted and then descriptively analyzed the following characteristics of the registered trials: study design, status, phase, primary endpoints, experimental interventions, and geographic location among other qualifiers. RESULTS: We identified 1,308 eligible registered trials. Most trials were registered with ClinicalTrials.gov (n = 703; 53.7%) and the Chinese Clinical Trial Registry (n = 291; 22.2%). The number of participants to be enrolled across these trials was 734,657, with a median of 110 participants per trial. The most commonly studied intervention category was pharmacologic (n = 763; 58.3%), with antiparasitic medications being the most common subcategory. Although over half of the trials were already recruiting, we identified published peer-reviewed results for only 8 of those trials. CONCLUSION: There is a relatively large number of registered trials but with very few results published so far. Although our findings suggest an appropriate initial response by the research community, the real challenge will be to get these trials completed, published, and translated into practice and policy.


Assuntos
Ensaios Clínicos como Assunto/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Humanos , Sistema de Registros
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