FDA given new powers over data reporting to national clinical trials registry

BMJ ◽  
2012 ◽  
Vol 345 (oct02 2) ◽  
pp. e6629-e6629 ◽  
Author(s):  
B. Roehr
Keyword(s):  
Clinical Trials ◽  
Data Reporting ◽  
Clinical Trials Registry

scholarly journals Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

2021 ◽  
Author(s):  
Christian Thiele ◽  
Gerrit Hirschfeld ◽  
Ruth von Brachel
Keyword(s):  
Clinical Trials ◽  
Random Forest ◽  
Random Forest Model ◽  
Scientometric Analysis ◽  
Data Set ◽  
The Public ◽  
Forest Model ◽  
Clinical Trial Registries ◽  
Multiple Primary ◽  
Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

scholarly journals Oc021—Clinical Trials Registry And Good Clinical Practice: In Indian Scenario

2013 ◽  
Vol 35 (8) ◽  
pp. e9
Author(s):  
A. Prakash ◽  
B. Medhi ◽  
S. Kaur ◽  
S. Kumari ◽  
P. Sarotra
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Good Clinical Practice ◽  
Clinical Trials Registry ◽  
Indian Scenario

Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

2018 ◽  
Vol 28 (4) ◽  
pp. 955-962 ◽  
Author(s):  
Rebecca Mercieca-Bebber ◽  
◽  
Douglas Williams ◽  
Margaret-Ann Tait ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
New Zealand ◽  
Clinical Trials Registry

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy

2018 ◽  
Vol 13 (8) ◽  
pp. 863-880 ◽  
Author(s):  
Erin Godecke ◽  
Tapan Rai ◽  
Dominique A Cadilhac ◽  
Elizabeth Armstrong ◽  
Sandy Middleton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Steering Committee ◽  
Aphasia Therapy ◽  
Detailed Statistical Analysis ◽  
Registration Number ◽  
Clinical Trials Registry ◽  
Potential Trial ◽  
Stroke Trial

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

scholarly journals Pharmacokinetics of Piperaquine and Safety Profile of Dihydroartemisinin-Piperaquine Coadministered with Antiretroviral Therapy in Malaria-Uninfected HIV-Positive Malawian Adults

2018 ◽  
Vol 62 (8) ◽  
Author(s):  
Clifford G. Banda ◽  
Fraction Dzinjalamala ◽  
Mavuto Mukaka ◽  
Jane Mallewa ◽  
Victor Maiden ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Antiretroviral Therapy ◽  
Hiv Positive ◽  
Adult Treatment ◽  
Limited Data ◽  
Time Curve ◽  
Parallel Group ◽  
Immunodeficiency Virus ◽  
Adult Dose ◽  
Clinical Trials Registry

ABSTRACTThere are limited data on the pharmacokinetic and safety profiles of dihydroartemisinin-piperaquine (DHA-PQ) among human immunodeficiency virus-infected (HIV-positive [HIV+]) individuals taking antiretroviral therapy (ART). In a two-step (parallel-group) pharmacokinetic trial with intensive blood sampling, we compared the area under the concentration-time curve from days 0 to 28 (AUC0–28 days) and the safety outcomes of piperaquine among malaria-uninfected HIV+adults. In step 1, half the adult dose of DHA-PQ was administered for 3 days as an initial safety check to four groups (n= 6/group) of HIV+adults (age ≥18 years): (i) antiretroviral-naive individuals, (ii) individuals on nevirapine-based ART, (iii) individuals on efavirenz-based ART, and (iv) individuals on ritonavir-boosted lopinavir-based ART. In step 2, a full adult treatment course of DHA-PQ was administered to a different cohort of participants in three groups: (i) antiretroviral-naive individuals, (ii) individuals on efavirenz-based ART, and (iii) individuals on nevirapine-based ART (n= 10 to 15/group). The ritonavir-boosted lopinavir-based ART group was dropped in step 2 due to the limited number of participants who were on this second-line ART and were eligible for recruitment. Piperaquine's AUC0–28 daysin both steps was 43% lower among participants on efavirenz-based ART than among ART-naive participants. There were no significant differences in AUC0–28 daysbetween the other ART groups and the ART-naive group in each of the two steps. Furthermore, no differences in treatment-emergent clinical and laboratory adverse events were observed across the groups in steps 1 and 2. Although it was well tolerated at the half and full standard adult treatment courses, the efavirenz-based antiretroviral regimen was associated with reduced piperaquine exposure, which may compromise dihydroartemisinin-piperaquine's effectiveness in programmatic settings. (The clinical trials presented in this study have been registered at the WHO's International Clinical Trials Registry Platform under ID numbers PACTR2010030001871293 and PACTR2010030001971409.)

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