Dataset Information

How the clinical research community responded to the COVID-19 pandemic: an analysis of the COVID-19 clinical studies in ClinicalTrials.gov.

ABSTRACT:

Objective

In the past few months, a large number of clinical studies on the novel coronavirus disease (COVID-19) have been initiated worldwide to find effective therapeutics, vaccines, and preventive strategies for COVID-19. In this study, we aim to understand the landscape of COVID-19 clinical research and identify the issues that may cause recruitment difficulty or reduce study generalizability.

Methods

We analyzed 3765 COVID-19 studies registered in the largest public registry-ClinicalTrials.gov, leveraging natural language processing (NLP) and using descriptive, association, and clustering analyses. We first characterized COVID-19 studies by study features such as phase and tested intervention. We then took a deep dive and analyzed their eligibility criteria to understand whether these studies: (1) considered the reported underlying health conditions that may lead to severe illnesses, and (2) excluded older adults, either explicitly or implicitly, which may reduce the generalizability of these studies to the older adults population.

Results

Our analysis included 2295 interventional studies and 1470 observational studies. Most trials did not explicitly exclude older adults with common chronic conditions. However, known risk factors such as diabetes and hypertension were considered by less than 5% of trials based on their trial description. Pregnant women were excluded by 34.9% of the studies.

Conclusions

Most COVID-19 clinical studies included both genders and older adults. However, risk factors such as diabetes, hypertension, and pregnancy were under-represented, likely skewing the population that was sampled. A careful examination of existing COVID-19 studies can inform future COVID-19 trial design towards balanced internal validity and generalizability.

SUBMITTER: He Z

PROVIDER: S-EPMC8083215 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundCOVID-19 has triggered an avalanche of research publications, the various aspects of which need to be assessed. The objective of this study is to determine the scientific community's response patterns to COVID-19 through a bibliometric analysis of the time-trends, global contribution, international collaboration, open-access provision, science domains of focus, and the behavior of journals.MethodsThe bibliographic records on COVID-19 literature were retrieved from both PubMed and Scopus. The period for searching was set from November 1, 2019, to April 15, 2021. The bibliographic data were coupled with COVID-19 incidence to explore possible association, as well as World Bank indicators and classification of economies.ResultsA total of 159132 records were included in the study. Following the escalation of incidences of COVID-19 in late 2020 and early 2021, the monthly publication count made a new peak in March 2021 at 20505. Overall, 125155 (78.6%) were national, 22548 (14.2%) were bi-national, and 11429 (7.2%) were multi-national. Low-income countries with 928 (66.8%) international publications had the highest percentage of international. The open-access provision decreased from 85.5% in February 2020 to 62.0% in April 2021. As many as 82841 (70.8%) publications were related to health sciences, followed by life sciences 27031 (23.1%), social sciences 20291 (17.3%), and physical sciences 15141 (12.9%). The top three medical subjects in publications were general internal medicine, public health, and infectious diseases with 28.9%, 18.3%, and 12.6% of medical publications, respectively.ConclusionsThe association between the incidence and publication count indicated the scientific community's interest in the ongoing situation and timely response to it. Only one-fifth of publications resulted from international collaboration, which might lead to redundancy without adding significant value. Our study underscores the necessity of policies for attraction of international collaboration and direction of vital funds toward domains of higher priority.

Project description:ObjectiveTo study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials.MethodsOn June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8, 2022, as ones possibly impacted by the pandemic. We selected all interventional trials in any stage and country that were "recruiting," "active, not recruiting," "enrolling by invitation," "suspended," "terminated," "completed," or "withdrawn" and excluded trials that had been completed or discontinued before 2020, had incomplete data, trials in which the eye was not the primary focus of the trial (e.g., Chediak-Higashi syndrome, myasthenia gravis). The following trial-level characteristics were collected: location, trial status, enrollment count, ocular condition, sponsors, intervention purpose, trial phase (I-IV), randomization, number of arms, and reasons for discontinuation. In addition to calculating descriptive statistics, we assessed whether trial characteristics differed between ophthalmology clinical trials canceled due to COVID-19 and those canceled for other reasons.ResultsFollowing the screening, 2280/12,679 (18%) ophthalmology clinical trials were retained. Of these, 142 (6.2%) were discontinued between January 1, 2020 and June 8, 2022. Moreover, 34 out of 142 (23.9%) ophthalmology clinical trials were discontinued due to COVID-19. These trials were more likely to be sponsored by academic medical centers (26/34, 76.5% vs 57/108, 52.8%, p = 0.03) and were not assigned to a specific study phase, indicating they were not investigational new drugs (22/34, 64.7% vs 46/108 42.6%, p = 0.003).ConclusionsCOVID-19-related trial discontinuations were more likely to be reported by academic medical centers and associated with trials investigating fully approved drugs, medical devices, procedures, diagnostic imaging, and behavioral changes. Further investigation of these characteristics may lead to a more robust and resilient understanding of the causes of early termination of these clinical trials.

Project description:BackgroundSince the national clinical trials registry ( ClinicalTrials.gov ) launched in February 2000, more than 360,000 research studies in the United States and over 200 countries have registered. As the characteristics of pediatric clinical studies keep changing over time and the results-reporting mechanism is under evolving, to know about the relevant updates of data elements and the effect of policies on the quality of reporting results is significant.MethodsIn this research, 53,060 clinical studies related to children registered from January 2008 to December 2019 were downloaded from ClinicalTrials.gov on August 1st, 2020. Different types of studies and critical categorical variables were identified, based on which, Cochran-Armitage test was performed to explore temporal trend of study characteristics and common pediatric clinical conditions in four time subsets. Further, to examine heterogeneity among subgroups (funding sources, funding sites, pediatric clinical conditions,etc), chi-squared test was applied.ResultsA total of 36,136 clinical trials and 16,692 observational studies were identified during the study period. The pediatric clinical trials increased from 7,029 (January 2008-December 2010) to 11,738 (January 2017-December 2019). The number of missing data has declined, with the maximum extent decline from 3.7 to 0.0% (Z = - 15.90, p < 0.001). Drug trials decreased from 48.8 to 28.9% (Z = - 24.68, p < 0.001). Behavioral trials, on the other hand, increased from 12.6 to 20.4% (Z = 12.28, p < 0.001). Most pediatric clinical trials were small-scale (58.9% enrolling 1-100 participants), single-site (61.4%) and funded neither by industry nor by the NIH (59.2%). The proportion of reporting study results varied by study type (χ2 = 1,256.8, p < 0.001), lead sponsor (χ2 = 4,545.6, p < 0.001), enrollment (χ2 = 29.4, p < 0.001) and trial phase (χ2 = 218.8, p < 0.001).ConclusionPediatric clinical studies registered in ClinicalTrials.gov were dominated by small-scale interventional trials, containing significant heterogeneity in funding sources, funding sites, pediatric clinical conditions and study characteristics. Although the results database has evolved in the past decade, efforts to strengthen the practice of systematic reporting must be continued.

Project description:ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of 'virtual' clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019-February 2020) compared with the 10 months following (May 2020-February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants' COVID-19 diagnosis.