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1.
Int J Gen Med ; 16: 1123-1136, 2023.
Article in English | MEDLINE | ID: covidwho-2298797

ABSTRACT

Objective: The purpose of this study was to characterize real-world studies (RWSs) registered at ClinicalTrials.gov to help investigators better conduct relevant research in clinical practice. Methods: A retrospective analysis of 944 studies was performed on February 28, 2023. Results: A total of 944 studies were included. The included studies involved a total of 48 countries. China was the leading country in terms of the total number of registered studies (37.9%, 358), followed by the United States (19.7%, 186). Regarding intervention type, 42.4% (400) of the studies involved drugs, and only 9.1% (86) of the studies involved devices. Only 8.5% (80) of the studies mentioned both the detailed study design type and data source in the "Brief Summary". A total of 49.4% (466) of studies had a sample size of 500 participants and above. Overall, 63% (595) of the studies were single-center studies. A total of 213 conditions were covered in the included studies. One-third of the studies (32.7%, 309) involved neoplasms (or tumors). China and the United States were very different regarding the study of different conditions. Conclusion: Although the pandemic has provided new opportunities for RWSs, the rigor of scientific research still needs to be emphasized. Special attention needs to be given to the correct and comprehensive description of the study design in the Brief Summary of registered studies, thereby promoting communication and understanding. In addition, deficiencies in ClinicalTrials.gov registration data remain prominent.

2.
Front Aging Neurosci ; 14: 996234, 2022.
Article in English | MEDLINE | ID: covidwho-2251369

ABSTRACT

Background: Gut microbiota may influence brain functions. Therefore, we prepared a study protocol for a double-blind, crossover, randomized clinical trial to determine the complex effects of human probiotics on memory, psychological, and biological measures in the elderly. Methods: We selected eligible participants using an effective electronic questionnaire containing the inclusion and exclusion criteria and a brief electronic cognitive test. One-third of the respondents with the worst cognitive scores on the electronic test are randomized to group A, starting with a 3-month probiotic intervention, and to group B, starting with a placebo. In a crossover design, both groups change their intervention/placebo status after 3 months for the next 3 months. Participants refusing longer personal assessments due to the COVID-19 pandemic were randomly allocated to one of two subgroups assessed online. Participants in both groups are matched in age, education, gender, and cognitive scores on electronic testing at baseline. At three time points, participants are assessed using a neuropsychological battery, self-report measures of mood, a physical fitness test, blood, urine, and stool samples, and actigraphy. A subset of participants also provided their biological samples and underwent the neuropsychological battery in an extended testing phase 3 months after study termination to find out the long-term effect of the intervention. Discussion: This is the first trial to address the comprehensive effects of human probiotics on memory and many other measures in the elderly. We assume that the probiotic group will have better outcomes than the placebo group after the first and second trimesters. We expect that the probiotic effect will persist for the next 3 months. These study's findings will contribute to an interesting area of how to improve memory, psychological and biological and other factors naturally and will examine the importance of probiotics for overall health in the elderly. Clinical trial registration: [clinicaltrials.gov], identifier [NCT05051501].

3.
Information Services and Use ; 42(3-4):409-416, 2022.
Article in English | Scopus | ID: covidwho-2198482

ABSTRACT

Throughout its nearly two hundred year existence, the National Library of Medicine (NLM) (https://www.nlm.nih.gov/) has advanced biomedicine and public health by acquiring, organizing, preserving, and disseminating knowledge essential to health and medicine. NLM has devised many innovations including standard terminologies and messaging formats such as the Journal Article Tag Suite (https://dtd.nlm.nih.gov/) to organize and manage biomedical literature. While scientific communication largely relied on books and journals over the last two hundred years, digital data are quickly forming the substrate of scientific communications. Data come in forms with much less structure than that afforded by publications, and these can vary from observations made during carefully controlled clinical trials to streams of genomic sequences to the counts of footfalls captured by personal devices. Coincidently, an increasingly diverse set of users - from clinicians to laypeople to public health to big pharma to scientists - bring unique perspectives as they draw meaning from new sets of scientific output. How does a modern library meet its mission to acquire, organize, preserve, and disseminate the many outputs of contemporary science? What role do standards play? How does NLM help this diverse set of stakeholders derive meaning from its resources? © 2022 - The authors. Published by IOS Press.

4.
Newspaper Research Journal ; : 1, 2023.
Article in English | Academic Search Complete | ID: covidwho-2194955

ABSTRACT

The COVID-19 pandemic has underscored the role news organizations play in disseminating information and shaping public response to the crisis. This study adopts an ecological approach in examining Russian regional journalists' adaptations to the pandemic. Based on in-depth interviews, the study found that a worsened economic situation has increased dependence on state subsidies. Journalists avoided questioning authorities' response to COVID, with some publishing government information and others focusing on practical tips for readers. [ FROM AUTHOR]

5.
Int J Gen Med ; 15: 8787-8796, 2022.
Article in English | MEDLINE | ID: covidwho-2197668

ABSTRACT

Background: Mental disorders are among the leading causes of the global health-related burden, and depression is one of the most disabling mental disorders. The emergence of the COVID-19 pandemic has created an environment where many determinants of mental health are exacerbated. Many studies have been registered and conducted over the past 16 years, but how to choose the proper design for depression clinical trials remains the main concern. This study aimed to characterize the current status of global depression clinical trials registered on ClinicalTrials.gov. Methods: We examined all the trials registered on ClinicalTrials.gov from 2007 to 2021. Results: Overall, 7623 depression clinical trials were identified for analysis. Of those trials, 6402 (83.98%) were intervention trials and 1212 (15.90%) were observational trials. The majority of intervention types were behavioral (35.2%) and drug (28.55%), with very few procedures, dietary supplements, and diagnostic test studies. In addition, 55.53% of trials enrolled <100 participants. The proportions of trials registered in North America were higher than on other continents. Furthermore, the trials that involved only females (12.6%) were more than only males (0.87%) from 2019 to 2021. Conclusion: Depression clinical trials registered on ClinicalTrials.gov were dominated by small sample size trials, and there is a lack of trials related to COVID-19. The choice of study design is crucial, and properly designed trials can help improve study efficiency and reduce the likelihood of study failure. Given the increased number of RCT trials, the trial quality is gradually improving over the years. In addition, depression trials concentrating on children and older adults need more scientific attention. Further studies related to COVID-19 are needed, given the great damage that causes to people's physical and mental health.

6.
Int J Mol Sci ; 24(1)2023 Jan 02.
Article in English | MEDLINE | ID: covidwho-2166601

ABSTRACT

Nanoparticles are heterologous small composites that are usually between 1 and 100 nanometers in size. They are applied in many areas of medicine with one of them being drug delivery. Nanoparticles have a number of advantages as drug carriers which include reduced toxic effects, increased bioavailability, and their ability to be modified for specific tissues or cells. Due to the exciting development of nanotechnology concomitant with advances in biotechnology and medicine, the number of clinical trials devoted to nanoparticles for drug delivery is growing rapidly. Some nanoparticles, lipid-based types, in particular, played a crucial role in the developing and manufacturing of the two COVID-19 vaccines-Pfizer and Moderna-that are now being widely used. In this analysis, we provide a quantitative survey of clinical trials using nanoparticles during the period from 2002 to 2021 as well as the recent FDA-approved drugs (since 2016). A total of 486 clinical trials were identified using the clinicaltrials.gov database. The prevailing types of nanoparticles were liposomes (44%) and protein-based formulations (26%) during this period. The most commonly investigated content of the nanoparticles were paclitaxel (23%), metals (11%), doxorubicin (9%), bupivacaine and various vaccines (both were 8%). Among the FDA-approved nanoparticle drugs, polymeric (29%), liposomal (22%) and lipid-based (21%) drugs were the most common. In this analysis, we also discuss the differential development of the diverse groups of nanoparticles and their content, as well as the underlying factors behind the trends.


Subject(s)
COVID-19 , Nanoparticles , Humans , COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Liposomes , Lipids
7.
Internationales Asien Forum International Quarterly for Asian Studies ; 53(3):327-336, 2022.
Article in English | ProQuest Central | ID: covidwho-2125949
8.
Cell Rep Med ; 3(9): 100728, 2022 09 20.
Article in English | MEDLINE | ID: covidwho-1984241

ABSTRACT

There is a need for safe and effective platform vaccines to protect against coronavirus disease 2019 (COVID-19) and other infectious diseases. In this randomized, double-blinded, placebo-controlled phase 2/3 trial, we evaluate the safety and efficacy of a multi-dose Bacillus Calmette-Guérin (BCG) vaccine for the prevention of COVID-19 and other infectious disease in a COVID-19-unvaccinated, at-risk-community-based cohort. The at-risk population is made of up of adults with type 1 diabetes. We enrolled 144 subjects and randomized 96 to BCG and 48 to placebo. There were no dropouts over the 15-month trial. A cumulative incidence of 12.5% of placebo-treated and 1% of BCG-treated participants meets criteria for confirmed COVID-19, yielding an efficacy of 92%. The BCG group also displayed fewer infectious disease symptoms and lesser severity and fewer infectious disease events per patient, including COVID-19. There were no BCG-related systemic adverse events. BCG's broad-based infection protection suggests that it may provide platform protection against new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogens.


Subject(s)
COVID-19 , Communicable Diseases , Diabetes Mellitus, Type 1 , Mycobacterium bovis , Adult , BCG Vaccine/therapeutic use , COVID-19/prevention & control , Diabetes Mellitus, Type 1/drug therapy , Humans , SARS-CoV-2 , Vaccination
9.
Health Education and Health Promotion ; 10(2), 2022.
Article in English | Scopus | ID: covidwho-1958273

ABSTRACT

Aims: This study aimed to design and psychometric a tool for measuring knowledge, beliefs and behavior of teachers regarding COVID-19 preventive behaviors. The goal is to create a tool that may be used to create an educational intervention that promotes preventive behaviors. Methods: A 60 item scale regarding COVID-19 preventive behaviors was developed upon literature review. Then, face and content validity were evaluated using quantitative and qualitative methods, through the involvement of the participants and expert panel. The internal consistency and reliability were assessed and approved using Cronbach's alpha index and test-retest. Findings: The face and content validity of the primarily developed scale was confirmed by item impacts of 1.5, 0.49 CVR and 0.79 CVI, and the number of items dropped to 60. The reliability of the instrument was approved by Cronbach's alpha of 0.67 to 0.95 and a correlation coefficient of 0.65 to 0.93. Conclusion: Based on the results, the scale that was developed using the constructs of the HBM for COVID-19 preventive behaviors among teachers had appropriate validity and reliability. © 2022, Tarbiat Modares University. All rights reserved.

10.
Front Pediatr ; 10: 860610, 2022.
Article in English | MEDLINE | ID: covidwho-1887122

ABSTRACT

Objective: Childhood obesity is one of the most severe challenges of public health in the twenty-first century and may increase the risk of various physical and psychological diseases in adulthood. The prevalence and predictors of unreported results and premature termination in pediatric obesity research are not clear. We aimed to characterize childhood obesity trials registered on ClinicalTrials.gov and identify features associated with early termination and lack of results reporting. Methods: Records were downloaded and screened for all childhood obesity trials from the inception of ClinicalTrials.gov to July 29, 2021. We performed descriptive analyses of characteristics, Cox regression for early termination, and logistic regression for lack of results reporting. Results: We identified 1,312 trials registered at ClinicalTrials.gov. Among clinicalTrials.gov registered childhood obesity-related intervention trials, trial unreported results were 88.5 and 4.3% of trials were prematurely terminated. Additionally, the factors that reduced the risk of unreported outcomes were US-registered clinical studies and drug intervention trials. Factors associated with a reduced risk of early termination are National Institutes of Health (NIH) or other federal agency funding and large trials. Conclusion: The problem of unreported results in clinical trials of childhood obesity is serious. Therefore, timely bulletin of the results and reasons for termination remain urgent aims for childhood obesity trials.

11.
Health Education and Health Promotion ; 10(1):137-144, 2022.
Article in English | Scopus | ID: covidwho-1877317

ABSTRACT

Aims: The internship course is an essential component of the nursing undergraduate program. This study was aimed to explore nursing students' experiences of role transition in the internship program during the COVID‐19 pandemic. Participant & Methods: This qualitative study was conducted on last semester’s nursing students practicing in an internship course during the COVID‐19 pandemic at Lorestan University of Medical Sciences, Iran from February to June 2021. The internship BSc nursing students were selected by a purposive sampling that reached 12 students by achieving data saturation. Findings: The findings included 5 categories of psychological challenges, unsuitable professional support and supervision, self‐centeredness and independence, mandatory restrictions, and acquiring a professional identity. Conclusion: The internship curriculum must be planned and supervised in a nursing education program by faculty authorities to prepare senior nursing students to enter the workplace, not only for their career retention but also for their actual growth/development in any workplace. © 2022, Tarbiat Modares University. All rights reserved.

12.
Health Education and Health Promotion ; 10(1):99-107, 2022.
Article in English | Scopus | ID: covidwho-1824393

ABSTRACT

Aims: Major traumatic events such as the COVID-19 pandemic and the related lockdown can affect the family as the fundamental unit of all societies. This study aimed to explain family members’ psychological experiences of the COVID-19 lockdown. Participants & Methods: This qualitative study was conducted from October 2020 to February 2021 on Public population living in Khorramabad, Iran. The sample size that achieved data saturation was 29 by purposive sampling. Unstructured in-depth interviews were used to collect the data. The inductive content analysis approach proposed by Graneheim & Lundman was used to analyze the data. Findings: Both positive (movement toward the expansion of the worldview and a sense of pleasure and happiness) and negative (anxiety, a sense of isolation, intensification of loneliness, mood and energy changes, hardship and fatigue from lockdown, boredom, anger, depression, disruption of the sleep-wake patterns, being fed up with limitations, feelings of helplessness, more frequent family disputes and arguments and Internet abuse) psychological aspects were recognized, each of which had some subcategories. Conclusion: The COVID-19 pandemic lockdown created negative and disruptive experiences and positive and constructive experiences for different individuals. © 2022, Tarbiat Modares University. All rights reserved.

13.
Health Education and Health Promotion ; 10(1):83-88, 2022.
Article in English | Scopus | ID: covidwho-1824002

ABSTRACT

Aims: Preventive behaviors play an important role in reducing mortality caused by this disease. This study aimed to determine the application of the extended theory of planned behavior to predicting preventive behaviors against COVID-19. Instrument & Methods: In this descriptive-analytical cross-sectional study, 416 university students were selected and examined through virtual networks through convenience and snowball sampling methods. The data collection tool was developed by the researcher-made questionnaire based on the extended theory of planned behavior. Data were analyzed using descriptive statistics and correlation test and linear regression by SPSS 18 software. Findings: A positive and significant correlation was observed between the mean of all the studied theoretical constructs with preventive behaviors against COVID-19 (p<0.01). Attitudes, subjective norms, perceived behavioral control, and perception of others' behavior predicted 43% of behavioral intention variance. Moreover, behavioral intention perceived behavioral control and perception of others’ behavior predicted 56% of preventive behaviors variance against COVID-19. Behavioral intention, attitude, perception of others' behavior, subjective norms, and perceived behavioral control had the greatest impact on COVID-19 preventive behaviors. Conclusion: The extended theory of planned behavior can be used as an appropriate framework in designing educational interventions to promote preventive behaviors against COVID-19. © 2022, Tarbiat Modares University. All rights reserved.

14.
Healthcare (Basel) ; 10(3)2022 Mar 07.
Article in English | MEDLINE | ID: covidwho-1731997

ABSTRACT

This study aimed to assess the trend in oncology trial commencements registered on ClinicalTrials.gov and to evaluate the contributing factors by comparing the trends in the pre- and post-COVID-19 pandemic era. The ClinicalTrials.gov database was searched to identify oncology study trials starting from 1 January 2018 to 28 February 2021. Data on the variables of start/complete date, phase, status, funding source, center, country and study type were extracted. According to the time point of the COVID-19 pandemic declaration by the World Health Organization (WHO), March 2020, we analyzed the extracted data, including interrupted time series (ITS) analysis and multivariable regression analysis. We identified 18,561 new oncology trials during the study period. A total of 5678 oncology trials in the prepandemic period and 6134 in the postpandemic period were included in the comparative analysis. The year 2020 had the most newly launched trials (32.3%), and the majority of trials were planned to be conducted for longer than two years (70.3%). The results of ITS show the trend in the commencement of oncology trials was significantly increased after the pandemic declaration (coefficient = 27.99; 95% CI = 19.27 to 36.71). Drug intervention trials were the largest contributor to the increased trial number compared to different interventions, such as trials of devices or procedures (OR = 1.14; 95% CI = 1.03 to 1.26, OR = 1.09; 95% CI = 0.91 to 1.29, and OR = 1.12; 95% CI = 0.96 to 1.31, respectively), whereas the United Kingdom was the highest contributor to the number of decreased trials (OR = 0.67; 95% CI = 0.51 to 0.89 p = 0.01) in the postpandemic era. The interruption in oncology trial initiation was diminished shortly after the COVID-19 pandemic declaration, which was influenced by several factors, such as interventions or national responses. Based on the current outcomes, appropriate strategies for developing oncology trials can be planned to mitigate the impact of future crises on oncology trials.

15.
Contemp Clin Trials ; 115: 106709, 2022 04.
Article in English | MEDLINE | ID: covidwho-1693814

ABSTRACT

BACKGROUND: This survey of COVID-19 interventional studies encompasses, and expands upon, a previous publication [1] examining individual participant level data (IPD) sharing intentions for COVID-related trials and publications prior to June 30, 2020. METHODS: Replicating our inclusion criteria from the original survey, we evaluated a larger dataset of 2759 trials and 281 publications in this follow-up survey for willingness to share IPD and studied if sharing sentiment has evolved since the beginning of the pandemic. RESULTS: We found that 18 months into the pandemic, data sharing intentions remained static at 15% for trials registered through ClinicalTrials.gov (ClinicalTrials.gov is a digital registry of information about publicly and privately funded clinical studies in which human volunteers participate in interventional or observational scientific research) prior to September 19, 2021 compared to our initial survey. However, a comparison of declared intentions to share IPD at the time of publication revealed a noticeable shift: affirmative intentions grew from 21.4% (6/28) in our original publications survey to 57% (160/281) in this survey. Within the subset of studies published within journals affiliated with the International Committee of Medical Journal Editors (ICMJE), positive sharing intentions are even higher (65%). CONCLUSIONS: Although intent to share data at the time of registration has not changed from our prior study in June 2020, there is growing commitment to sharing data reflected in the increasing number of affirmative declarations at the time of publication. Actual sharing of data will accelerate new insights into COVID-19 through secondary re-use of data.


Subject(s)
COVID-19 , Clinical Trials as Topic , Information Dissemination , COVID-19/epidemiology , Humans , Intention , Pandemics , Research Design
16.
Fundamentals and Methods of Machine and Deep Learning ; n/a(n/a):101-119, 2022.
Article in English | Wiley | ID: covidwho-1664336

ABSTRACT

Summary During an epidemic period, it is important to perform the time forecasting analysis to track the growth of pandemic and plan accordingly to overcome the situation. The paper aims at performing the time forecasting of coronavirus disease 2019 (COVID-19) with respect to confirmed, recovered, and death cases of Karnataka, India. The modified mathematical epidemiological model used here are Susceptible - Exposed - Infectious - Recovered (SEIR) and recurrent neural network such as long short-term memory (LSTM) for analysis and comparison of the simulated output. To train, test, and optimize the model, the official data from Health and Family Welfare Department - Government of Karnataka is used. The evaluation of the model is conducted based on root mean square logarithmic error (RMSLE). The Covid-19 pandemic has a major impact not only on public health and daily living, but also on clinical trials worldwide. To investigate the potential impact of the Covid-19 pandemic on the initiation of clinical trials, we have descriptively analysed the longitudinal change in phase II and III interventional clinical trials initiated in Europe and in the United States. Based on the public clinical trial register EU Clinical Trials Register and clinicaltrials.gov, we conducted (a) a yearly comparison of the number of initiated trials from 2010 to 2020 and (b) a monthly comparison from January 2020 to February 2021 of the number of initiated trials. The analyses indicate that the Covid-19 pandemic affected both the initiation of clinical trials overall and the initiation of non-Covid-19 trials. An increase in the overall numbers of clinical trials could be observed both in Europe and the US in 2020 as compared to 2019. However, the number of non-Covid-19 trials initiated is reduced as compared to the previous decade, with a slightly larger relative decrease in the US as compared to Europe. Additionally, the monthly trend for the initiation of non-Covid-19 trials differs between regions. In the US, after a sharp decrease in April 2020, trial numbers reached the levels of 2019 from June 2020 onwards. In Europe, the decrease was less pronounced, but trial numbers mainly remained below the 2019 average until February 2021.

17.
J Clin Transl Sci ; 5(1): e111, 2021 Mar 16.
Article in English | MEDLINE | ID: covidwho-1275810

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, therapeutic, and preventative products, the healthcare community has initiated a staggering number of clinical trials. METHODS: ClinicalTrials.gov was reviewed to determine if trial sponsor type had a relationship to time to COVID-19 response, which was defined as the date from disease discovery in Wuhan, China to ClinicalTrials.gov study "First Posted" date. RESULTS: A total of 673 United States (US) sponsored, interventional study listings were retrieved, of which 293 (43.5%) were Industry-sponsored, 349 (51.9%) were Academic sponsored, and 31 (4.6%) were Other sponsor types. Of the Academic studies, 181 (51.9%) were Clinical and Translational Science Award (CTSA) hubs. The average response time for all sponsor types was 189 days, with Academic sponsors having the shortest average response time of 172.6 days (P < 0.001). CTSA hubs had a significantly (P < 0.001) shorter average response time (168.1 days) compared to all other sponsor types (197.4 days). However, while shorter in duration by 9.4 days, response time was not significantly different from non-CTSA sponsors (177.5 days; P = 0.238). Additionally, ANOVA indicated significant relationships (P < 0.001) between funding type, study phase, number of sites, and enrollment size on response time. CONCLUSIONS: Studies posted with the shortest response time were Academic-sponsored trials and included smaller sized investigations of repurposed approved or investigational drugs for the treatment of COVID-19 symptoms. A small second wave of study postings occurred approximately 4 months later, and included small, unique therapies targeting prevention or treatment of COVID-19.

18.
Stud Health Technol Inform ; 281: 514-515, 2021 May 27.
Article in English | MEDLINE | ID: covidwho-1247796

ABSTRACT

Introduction of core outcome sets (COS) facilitates evidence synthesis, transparency in outcome reporting, and standardization in clinical research. However, development of COS may be a time consuming and expensive process. Publicly available repositories, such as ClinicalTrials.gov (CTG), provide access to a vast collection of clinical trial characteristics including primary and secondary outcomes, which can be analyzed using a comprehensive set of tools. With growing number of COVID-19 clinical trials, COS development may provide crucial means to standardize, aggregate, share, and analyze diverse research results in a harmonized way. This study was aimed at initial assessment of utility of CTG analytics for identifying COVID-19 COS. At the time of this study, January, 2021, we analyzed 120 ongoing NIH-funded COVID-19 clinical trials initiated in 2020 to inform COVID-19 COS development by evaluating and ranking clinical trial outcomes based on their structured representation in CTG. Using this approach, COS comprised of 25 major clinical outcomes has been identified with mortality, mental health status, and COVID-19 antibodies at the top of the list. We concluded that CTG analytics can be instrumental for COVID-19 COS development and that further analysis is warranted including broader number of international trials combined with more granular approach and ontology-driven pipelines for outcome extraction and curation.


Subject(s)
COVID-19 , Humans , Outcome Assessment, Health Care , Research Design , SARS-CoV-2
19.
Trials ; 22(1): 260, 2021 Apr 08.
Article in English | MEDLINE | ID: covidwho-1175340

ABSTRACT

BACKGROUND: The COVID-19 pandemic has caused severe disruptions in care for many patients. A key question is whether the landscape of clinical research has also changed. METHODS: In a retrospective cohort study, we examined the association of the COVID-19 outbreak with new clinical trial activations. Trial data for all interventional and observational oncology, cardiovascular, and mental health studies from January 2015 through September 2020 were obtained from ClinicalTrials.gov . An interrupted time-series analysis with Poisson regression was used. RESULTS: We examined 62,252 trial activations. During the initial COVID-19 outbreak (February 2020 through May 2020), model-estimated monthly trial activations for US-based studies were only 57% of the expected estimate had the pandemic not occurred (relative risk = 0.57, 95% CI 0.52 to 0.61, p < .001). For non-US-based studies, the impact of the pandemic was less dramatic (relative risk = 0.77, 95% CI 0.73 to 0.82, p < .001), resulting in an overall 27% reduction in the relative risk of new trial activations for US-based trials compared to non-US-based trials (relative risk ratio = 0.73, 95% CI 0.67 to 0.81, p < .001). Although a rebound occurred in the initial reopening phase (June 2020 through September 2020), the rebound was weaker for US-based studies compared to non-US-based studies (relative risk ratio = 0.87, 95% CI 0.80 to 0.95, p < .001). CONCLUSIONS: These findings are consistent with the disproportionate burden of COVID-19 diagnoses and deaths during the initial phase of the pandemic in the USA. Reduced activation of cancer clinical trials will likely slow the pace of clinical research and new drug discovery, with long-term negative consequences for cancer patients. An important question is whether the renewed outbreak period of winter 2020/2021 will have a similarly negative impact on the initiation of new clinical research studies for non-COVID-19 diseases.


Subject(s)
COVID-19 , Clinical Trials as Topic/statistics & numerical data , Pandemics , Humans , Observational Studies as Topic , Retrospective Studies
20.
Front Pharmacol ; 11: 540187, 2020.
Article in English | MEDLINE | ID: covidwho-782038

ABSTRACT

OBJECTIVE: The quality and rationality of many recently registered clinical studies related to coronavirus disease 2019 (COVID-19) needs to be assessed. Hence, this study aims to evaluate the current status of COVID-19 related registered clinical trial. METHODS: We did an electronic search of COVID-19 related clinical studies registered between December 1, 2019 and February 21, 2020 (updated to May 28, 2020) from the ClinicalTrials.gov, and collected registration information, study details, recruitment status, characteristics of the subjects, and relevant information about the trial implementation process. RESULTS: A total of 1,706 studies were included 10.0% of which (n=171) were from France, 943 (55.3%) used an interventional design, and 600 (35.2%) used an observational design. Most of studies (73.6%) aimed to recruit fewer than 500 people. Interferon was the main prevention program, and antiviral drugs were the main treatment program. Hydroxychloroquine and chloroquine (230/943, 24.4%) were widely studied. Some registered clinical trials are incomplete in content, and 37.4% of the 1,706 studies may have had insufficient sample size. CONCLUSION: The quality of COVID-19 related studies needs to be improved by strengthening the registration process and improving the quality of clinical study protocols so that these clinical studies can provide high-quality clinical evidence related to COVID-19.

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