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Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

BACKGROUND: Clinical trials are mandatory for evidence-based practice. Hardly, any data are available regarding the number of clinical trials and their methodological quality that are conducted in allied fields of medicine. OBJECTIVE: The present study was envisaged to assess methodological quality...

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Autores principales: Kannan, S., Gowri, S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910572/
https://www.ncbi.nlm.nih.gov/pubmed/27297510
http://dx.doi.org/10.1016/j.jaim.2015.09.003
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author Kannan, S.
Gowri, S.
author_facet Kannan, S.
Gowri, S.
author_sort Kannan, S.
collection PubMed
description BACKGROUND: Clinical trials are mandatory for evidence-based practice. Hardly, any data are available regarding the number of clinical trials and their methodological quality that are conducted in allied fields of medicine. OBJECTIVE: The present study was envisaged to assess methodological quality of trials in allied medical fields. MATERIALS AND METHODS: Registered clinical trials in World Health Organization International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/AdvSearch.aspx) in the following fields were extracted: Acupuncture; Ayurveda; biofeedback; complementary and alternate medicine; herbal; homeopathy; massage; naturopathy; Reiki; Siddha; Unani; and yoga. The eligible studies were assessed for the following key details: Type of sponsors; health condition in which the trial has been conducted; recruitment status; study design; if randomization was present, method of randomization and allocation concealment; single or multi-centric; retrospective or prospective registration; and publication status in case of completed studies. RESULTS: A total of 276 clinical trials were registered majority of which have been proposed to be conducted in the field of oncology and psychiatry. Most of the clinical trials were done in single centers (87.75%), and almost all the clinical trials were investigator-initiated with pharmaceutical company sponsored studies contributing to a maximum extent of 24.5%. A large majority of the study designs were interventional where almost 85% of the studies were randomized controlled trials. However, an appropriate method of randomization was mentioned only in 27.4%, and the rate of allocation concealment was found to be just 5.5%. Only 1–2% of the completed studies were published, and the average rate of retrospective registration was found to be 23.6% in various fields. CONCLUSION: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.
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spelling pubmed-49105722016-06-23 Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform Kannan, S. Gowri, S. J Ayurveda Integr Med Original research article (Clinical) BACKGROUND: Clinical trials are mandatory for evidence-based practice. Hardly, any data are available regarding the number of clinical trials and their methodological quality that are conducted in allied fields of medicine. OBJECTIVE: The present study was envisaged to assess methodological quality of trials in allied medical fields. MATERIALS AND METHODS: Registered clinical trials in World Health Organization International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/AdvSearch.aspx) in the following fields were extracted: Acupuncture; Ayurveda; biofeedback; complementary and alternate medicine; herbal; homeopathy; massage; naturopathy; Reiki; Siddha; Unani; and yoga. The eligible studies were assessed for the following key details: Type of sponsors; health condition in which the trial has been conducted; recruitment status; study design; if randomization was present, method of randomization and allocation concealment; single or multi-centric; retrospective or prospective registration; and publication status in case of completed studies. RESULTS: A total of 276 clinical trials were registered majority of which have been proposed to be conducted in the field of oncology and psychiatry. Most of the clinical trials were done in single centers (87.75%), and almost all the clinical trials were investigator-initiated with pharmaceutical company sponsored studies contributing to a maximum extent of 24.5%. A large majority of the study designs were interventional where almost 85% of the studies were randomized controlled trials. However, an appropriate method of randomization was mentioned only in 27.4%, and the rate of allocation concealment was found to be just 5.5%. Only 1–2% of the completed studies were published, and the average rate of retrospective registration was found to be 23.6% in various fields. CONCLUSION: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations. Elsevier 2016-03 2016-05-24 /pmc/articles/PMC4910572/ /pubmed/27297510 http://dx.doi.org/10.1016/j.jaim.2015.09.003 Text en © 2016 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Publishing Services by Elsevier B.V. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original research article (Clinical)
Kannan, S.
Gowri, S.
Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform
title Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform
title_full Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform
title_fullStr Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform
title_full_unstemmed Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform
title_short Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform
title_sort clinical trials in allied medical fields: a cross-sectional analysis of world health organization international clinical trial registry platform
topic Original research article (Clinical)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910572/
https://www.ncbi.nlm.nih.gov/pubmed/27297510
http://dx.doi.org/10.1016/j.jaim.2015.09.003
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