The Exclusion of Patients with CKD in Prospectively Registered Interventional Trials for COVID-19-a Rapid Review of International Registry Data.
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ABSTRACT:
SUBMITTER: Major R
PROVIDER: S-EPMC7608999 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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The Exclusion of Patients with CKD in Prospectively Registered Interventional Trials for COVID-19-a Rapid Review of International Registry Data.
Major Rupert R Selvaskandan Haresh H Makkeyah Yahya Mostafa YM Hull Katherine K Kuverji Apexa A Graham-Brown Matthew M
Journal of the American Society of Nephrology : JASN 20200908 10
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Project description:BackgroundClinical Trials Registry - India (CTRI) was established in July 2007 and today hosts thousands of trials, a significant fraction of them registered in the last couple of years. We wished to undertake an up-to-date analysis of specific fields of the registered trials. In doing so we discovered problems with the quality of the data, which we describe in this paper.MethodsWe downloaded CTRI records and reformatted the data into an SQLite database, which we then queried. We also accessed ClinicalTrials.gov records as needed.ResultsWe discovered various categories of problems with the data in the CTRI database, including (1) a lack of clarity in the classification of Types of Study, (2) internal inconsistencies, (3) incomplete or non-standard information, (4) missing data, (5) variations in names or classification, and (6) incomplete or incorrect details of ethics committees. For most of these problems, error rates have been calculated, over time. Most were found to be in single digits, although others were significantly higher. We suggest how data quality in future editions of CTRI could be improved, including (1) a more elaborate and structured way of classifying the Type of Study, (2) the use of logic rules to prevent internal inconsistencies, (3) less use of free text fields and greater use of drop-down menus, (4) more fields to be made compulsory, (5) the pre-registration of individuals' and organizations' names and their subsequent selection from drop-down menus while registering a trial, and (6) more information about each ethics committee, including (a) its address and (b) linking the name of the trial site to the relevant ethics committee. As we discuss problems with the data of specific fields, we also examine - where possible - the quality of the data in the corresponding fields in ClinicalTrials.gov, the largest clinical trial registry in the world.ConclusionsIt is a scientific and ethical obligation to correctly record all information pertaining to each trial run in India. CTRI is a valuable database that has proved its worth in terms of improving the record of trials in the country. The suggestions made herein would improve it further.
| S-EPMC6712861 | biostudies-literature
Project description:There is widespread agreement that clinical trials should be registered in a public registry, preferably before the trial commences. It is also important that details of each trial in the public record are complete and accurate. In this study, we examined the trial sites and ethics committee (EC) data for 1359 recent Phase 2 or Phase 3 interventional trials registered with Clinical Trials Registry-India (CTRI), to identify categories of problems that prevent the clear identification of which EC approved a given site. We created an SQLite database that hosted the relevant CTRI records, and queried this database, as needed. We identified two broad categories of problems: those pertaining to the understanding of an individual trial and those to adopting a data analytics approach for a large number of trials. Overall, about 30 problems were identified, such as an EC not being listed; an uninformative name of the EC that precluded its clear identification; ambiguity in which EC supervised a particular site; repetition of a site or an EC; the use of a given acronym for different organizations; site name not clearly listed, etc. The large number of problems with the data in the EC or site field creates a challenge to link particular sites with particular ECs, especially if a programme is used to find the matches. We make a few suggestions on how the situation could be improved. Most importantly, list the EC registration number for each EC, merge the site and EC tables so that it is clear which EC is linked to which site; and implement logic rules that would prevent a trial from being registered unless certain conditions were met. This will raise user confidence in CTRI EC data, and enable data based public policy and inferences. This will also contribute to increased transparency, and trust, in clinical trials, and their oversight, in India.
| S-EPMC10021301 | biostudies-literature
Project description:Although ginseng has long been broadly used in clinical settings around the world, few clinical trials on ginseng have been conducted. The objective of this study was to provide a comprehensive evaluation of the characteristics of ginseng clinical trials registered in the WHO International Clinical Trials Registry Platform (ICTRP) as of December 2017 regarding their frequency, design, type of ginseng, dosage, duration, condition, funding sources, and publication status. A total of 134 ginseng clinical studies were registered from 2002 to 2017, of which 60.4% were completed and 23.1% are actively recruiting participants. A large number of trials were associated with aspects of high-quality trial design. Overall, 94% of the trials employed randomized allocation to study arms, 78.4% were double-blind studies using placebo as one of the control groups, and 71% were published as completed trials. Trials whose sample size was restricted to fewer than 100 participants accounted for 74.7% of the total. Of the primary funding sources for ginseng studies, 67.2% were nonindustry organizations. The ginseng clinical trials were heterogeneous with respect to ginseng species and variety, indications, dose, duration, and participant characteristics. Clearly, stricter and methodologically suitable studies are needed to demonstrate the efficacy and safety of ginseng.
| S-EPMC5818925 | biostudies-literature
Project description:BackgroundProspective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elements, including the start date, may change before the first patient is enrolled. If a trial changes its start date after recruiting began, however, it may indicate a reason for concern. This study aimed to measure the rate of "retroactively prospective" trials. This refers to trials that are originally registered retrospectively, with the start date before the registration date, but that retroactively change their start date to be after the registration date, making them appear as if they were prospectively registered.MethodsWe retrieved clinical trial history data for all clinical trials registered on ClinicalTrials.gov with a first registration date in the year 2015 (N = 11,908). Using automated analyses, we determined the timepoints of registration in relation to the start date of the trial over time. For retroactively prospective trials and a set of control trials, we manually checked the accompanying publications to determine which start date they report and whether they report changes to the start date.ResultsWe found 235 clinical trials to be retroactively prospective, comprising 2.0% of all clinical trials in our sample of 11,908 trials. Among the 113 retroactively prospective clinical trials with an accompanying publication, 12 (10.6%) explicitly stated in the publication that they had been prospectively registered.ConclusionsRetroactively prospective trial registration happens in one in 50 trials. While these changes to the start date could be mistakes or legitimate edits based on the most up-to-date information, they could also indicate a retrospectively registered trial that has been made to appear as a prospectively registered trial, which would lead to biases unapparent to reviewers. Our results point to the need for more transparent reporting of changes to a trial's details and have implications for the review and conduct of clinical trials, with our fully automated and freely available tools allowing reviewers or editors to detect these changes.Trial registrationThe preregistered protocol of our study is available via https://osf.io/rvq53 . The most recent version of the protocol lists all deviations from the original study plan, including the rationale behind the changes, and additional analyses that were conducted.
| S-EPMC10938677 | biostudies-literature
Project description:BackgroundA growing body of evidence shows that sharing health research data with other researchers for secondary analyses can contribute to better health. This is especially important in the context of a public health emergency when stopping a pandemic depends on accelerating science.MethodsWe analysed the information on data sharing collected by the 18 clinical trial registries included in the WHO International Clinical Trials Registry Platform (ICTRP) to understand the reporting of data sharing plans and which studies were and were not planning to share data. Data on sponsor and funder organisations, country of recruitment, registry, and condition of study were standardised to compare the sharing of information and data across these facets. This represents the first ever comprehensive study of the complete data set contained in ICTRP.ResultsAcross 132,545 studies registered between January 2019 and December 2020, 11.2% of studies stated that individual patient data (IPD) would be shared. Plans to share IPD varied across the 18 contributing registries- information on data sharing was missing in >95% of study records across 7/18 registries. In the 26,851 (20.3%) studies that were funded or sponsored by a commercial entity, intention to share IPD was similar to those that were not (11.5% vs 11.2%). Intention to share IPD was most common in studies recruiting across both high-income and low- or middle-income countries (21.4%) and in those recruiting in Sub-Saharan Africa (50.3%). Studies of COVID-19 had similar levels of data sharing to studies of other non-pandemic diseases in 2020 (13.7% vs 11.7%).ConclusionsRates of planned IPD sharing vary between clinical trial registries and economic regions, and are similar whether commercial or non-commercial agencies are involved. Despite many calls to action, plans to share IPD have not increased significantly and remain below 14% for diseases causing public health emergencies.
| S-EPMC8980676 | biostudies-literature
Project description:In multinational trials that have run in India, we wished to determine whether there was too much (60% or higher) recruitment from India. We downloaded all trial records from Clinical Trials Registry-India, CTRI, and stored them in a local SQLite database. We queried records registered in a recent 8-year period, ie 2013-2020 and evaluated the fraction of local participants in interventional Phase 2 or Phase 3 studies. 62 trials were completed, with completion dates available. Five trials (8%) had 60% or more planned recruitment from India. Four of the five (7% of 62) had a foreign sponsor, and therefore there was an unfair burden-benefit ratio on the Indian population. Seven trials (11%), of which six (10% of 62) had foreign sponsors, had 60% or more (of the total) actual recruitment from India, and for two trials (both with foreign sponsors), the data were meaningless. There were 362 studies that were listed as not completed, although, given their start date and estimated duration, some of them ought to have been. Twenty five cases (7% of 362) had 60% or more planned recruitment from India. Of these, 18 (5% of 362) had foreign sponsors and were potentially problematic. Even allowing for some delays in completion, 128 (35% of 362) studies ought to have been completed by the time of our study. As such, we identified several problematic trials for which the planned recruitment from India in multinational studies was 60% or more. We also identified trials in which the actual recruitment was significantly higher than the planned recruitment. Further, the records of several studies that were probably completed were not updated in CTRI in a timely manner. The Indian drug regulator needs to be particularly alert to the planned, or actual, over-recruitment of participants from India. Further, CTRI, alone or in collaboration with the regulator, needs to ensure that multinational trial records for the enrollment fields in particular are updated, in a timely manner.
| S-EPMC10511072 | biostudies-literature
Project description:BackgroundA better understanding of the current features of osteoporosis-related randomized clinical trials (RCTs) is important for improving clinical trial designs and promoting the translatability of results into benefits for patients. However, there is a lack of thorough evaluation of osteoporosis-related RCTs in middle-aged and older populations. Therefore, this study aimed to investigate the characteristics of registered RCTs on osteoporosis among middle-aged and older adults on the International Clinical Trials Registry Platform (ICTRP).MethodsOsteoporosis-related RCTs registered on the ICTRP were searched on December 31, 2020. The main features of eligible RCTs were assessed. We searched PubMed, Google scholar, Medline, and Embase databases for the publication status of completed RCTs.ResultsA total of 537 osteoporosis-related RCTs were identified for analysis. The number of registered RCTs increased rapidly in 2005 (N = 47). Of these, 346 (64.4%) RCTs involved only women and 275 (51.2%) were retrospectively registered. Most RCTs were of open-label design (61.3%). The most common primary purpose of osteoporosis-related RCTs was treatment (72.3%). Intervention investigated was mainly focused on medication (62.8%), followed by lifestyle or education (19.0%), and dietary supplement (10.4%). After trial completion, the results of only 140 (35.5%) RCTs were available on the ICTRP, and the publication rate after trial completion was 30.5%.ConclusionsRCTs on osteoporosis among middle-aged and older adults were dominated by retrospectively registered and open-label trials. Most trials lacked available results and associated publications. More awareness of prospective registration and blinding design in osteoporosis-related RCTs is needed. Further, publication and dissemination of RCTs results should be promoted.
| S-EPMC8438405 | biostudies-literature
Project description:Background/aimsThe registry ClinicalTrials.gov was created to provide investigators and patients an accessible database of relevant clinical trials.MethodsTo understand the state of sickle cell disease clinical trials, a comprehensive review of all 174 "closed," "interventional" sickle cell trials registered at ClinicalTrials.gov was completed in January 2015.ResultsThe majority of registered sickle cell disease clinical trials listed an academic center as the primary sponsor and were an early phase trial. The primary outcome for sickle cell disease trials focused on pain (23%), bone marrow transplant (BMT) (13%), hydroxyurea (8%), iron overload (8%), and pulmonary hypertension (8%). A total of 52 trials were listed as terminated or withdrawn, including 25 (14% of all trials) terminated for failure to enroll participants. At the time of this review, only 19 trials uploaded results and 29 trials uploaded a manuscript in the ClinicalTrials.gov database. A systematic review of pubmed.gov revealed that only 35% of sickle cell studies completed prior to 2014 resulted in an identified manuscript. In comparison, of 80 thalassemia trials registered in ClinicalTrials.gov, four acknowledged failure to enroll participants as a reason for trial termination or withdrawal, and 48 trials (60%) completed prior to 2014 resulted in a currently identified manuscript.ConclusionClinicalTrials.gov can be an important database for investigators and patients with sickle cell disease to understand the current available research trials. To enhance the validity of the website, investigators must update their trial results and upload trial manuscripts into the database. This study, for the first time, quantifies outcomes of sickle cell disease trials and provides support to the belief that barriers exist to successful completion, publication, and dissemination of sickle cell trial results.
| S-EPMC4643416 | biostudies-literature
Project description:ObjectiveThis study aimed to evaluate the pharmacological mechanisms of antiviral drugs against the novel coronavirus disease (COVID-19) and the study designs in clinical trials registered with the International Clinical Trials Registry Platform (ICTRP).MethodsClinical trials involving antiviral drugs for treating COVID-19 were retrieved from the ICTRP database. For each trial, the study design, number of participants, primary endpoints, source register, antiviral mechanism, and results were evaluated.ResultsOn June 10, 2020, 145 eligible clinical trials were retrieved from the ICTRP, of which 99 (68.3%) were randomized trials, 109 (75.2%) were parallel assignment trials, 38 (26.2%) were double or single blinded, 130 (89.7%) involved two groups, and 75 (51.6%) included more than 100 participants; and clinical improvement or recovery and virus-negative conversion were the two most common endpoints, accounting for 40.7% and 18.6%, respectively. The drugs were divided according to the antiviral mechanism into HIV reverse transcriptase inhibitors, RNA-dependent RNA polymerase inhibitors, HIV protease inhibitors (PIs), hepatitis C virus NS3 PIs, and anti-influenza drugs.ConclusionThe design characteristics of clinical trials of antiviral drugs for treating COVID-19 as well as the mechanism of action and antiviral efficacy of the drugs were evaluated in this study. The results of these trials could constitute a reference for future clinical trials to be executed on COVID-19 treatment and prevention.
| S-EPMC7509319 | biostudies-literature
Project description:The coronavirus disease 2019 (COVID-19) pandemic has led to a dramatic impact worldwide and presented unprecedented challenges for clinical and translational medicine. We assess the impact of COVID-19 on submitted and completed interventional clinical trials that have been registered on ClinicalTrials.gov. After classifying over 85% of the registered clinical trials by their source, we carefully model the number of submitted and completed trials before and after March 2020. Overall, we find minimal impact of COVID-19 on the number of submitted clinical trials, although a much more substantial impact is observed for completed clinical trials. We also show that clinical trials with a pharmaceutical sponsor were more successful at completing trials during the pandemic compared to the trials with academic/hospital/government sponsors.
| S-EPMC8212742 | biostudies-literature