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      An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India

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          Abstract

          Background

          Clinical 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.

          Methods

          We downloaded CTRI records and reformatted the data into an SQLite database, which we then queried. We also accessed ClinicalTrials.gov records as needed.

          Results

          We 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.

          Conclusions

          It 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.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-019-3592-0) contains supplementary material, which is available to authorized users.

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          Most cited references22

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          Racism and research: the case of the Tuskegee Syphilis Study.

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            Publication bias: the case for an international registry of clinical trials.

            A problem in evaluating different therapies from a review of clinical trials is that the published clinical trial literature may be biased in favor of positive or promising results. In this report, a model is proposed for reviewing clinical trial results which is free from publication bias based on the selection of trials registered in advance in a registry. The value of a registry is illustrated by comparing a review of published clinical trials located by a literature search with a review of registered trials contained in a cancer trials registry. Two therapeutic questions are examined: the survival impact of initial alkylating agent (AA) v combination chemotherapy (CC) in advanced ovarian cancer, and the survival impact of AA/prednisone v CC in multiple myeloma. In advanced ovarian cancer, a pooled analysis of published clinical trials demonstrates a significant survival advantage for combination chemotherapy (median survival ratio of CC to AA, 1.16; P = .02). However, no significant difference in survival is demonstrated based on a pooled analysis of registered trials (median survival ratio, 1.05; P = .25). For multiple myeloma, a pooled analysis of published trials also demonstrates a significant survival advantage for CC (median survival ratio, 1.26; P = 04), especially for poor risk patients (ratio, 1.66; P = .002). A pooled analysis of registered trials also shows a survival benefit for patients receiving combination chemotherapy (all patients, P = .06; poor risk, P = .03), but the estimated magnitude of the benefit is reduced (all patients: ratio, 1.11; poor risk: ratio, 1.22). These examples illustrate an approach to reviewing the clinical trial literature, which is free from publication bias, and demonstrate the value and importance of an international registry of all clinical trials.
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              Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination

              Background Clinical trials that end prematurely (or “terminate”) raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. Methods and Findings A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Conclusions Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.
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                Author and article information

                Contributors
                mounikarp95@gmail.com
                abhilash@ibab.ac.in
                gayatri@ibab.ac.in
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                28 August 2019
                28 August 2019
                2019
                : 20
                : 535
                Affiliations
                ISNI 0000 0004 0500 991X, GRID grid.418831.7, Institute of Bioinformatics and Applied Biotechnology, ; Biotech Park, Electronics City Phase 1, Bengaluru, Karnataka 560100 India
                Author information
                http://orcid.org/0000-0003-2410-1431
                Article
                3592
                10.1186/s13063-019-3592-0
                6712861
                31455366
                c591f5de-3832-4d81-bd7d-094c9a4eb398
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 11 April 2019
                : 16 July 2019
                Funding
                Funded by: Department of IT, BT and S&T of the Government of Karnataka
                Award ID: Not applicable
                Categories
                Research
                Custom metadata
                © The Author(s) 2019

                Medicine
                clinical trials,ctri,data integrity,missing data,error rates,india,clinicaltrials.gov
                Medicine
                clinical trials, ctri, data integrity, missing data, error rates, india, clinicaltrials.gov

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