Retrospective on global pulmonary hypertension clinical trials: 1999-2021

Data are quite sparse on the comprehensive analyses of pulmonary hypertension (PH) clinical trials worldwide. Information including participating countries (developed or developing), intervention type, trial size, PH categories, sponsorship, study phase, design strategies, and participants' dem...

Full description

Saved in:
Bibliographic Details
Published in:Journal of thoracic disease 2023-06, Vol.15 (6), p.3372-3385
Main Authors: Zheng, Lu, Tan, Jun, Yan, Yi, Wang, Shang, Yuan, Ping, Wu, Cheng, Zhao, Yin-Tao, Yang, Hai-Bo, Nappi, Francesco, Tonelli, Adriano R, Wang, Lan, Hu, Qing-Hua, Jiang, Rong
Format: Article
Language:English
Subjects:
Original
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by
cites
container_end_page 3385
container_issue 6
container_start_page 3372
container_title Journal of thoracic disease
container_volume 15
creator Zheng, Lu
Tan, Jun
Yan, Yi
Wang, Shang
Yuan, Ping
Wu, Cheng
Zhao, Yin-Tao
Yang, Hai-Bo
Nappi, Francesco
Tonelli, Adriano R
Wang, Lan
Hu, Qing-Hua
Jiang, Rong
description Data are quite sparse on the comprehensive analyses of pulmonary hypertension (PH) clinical trials worldwide. Information including participating countries (developed or developing), intervention type, trial size, PH categories, sponsorship, study phase, design strategies, and participants' demographic characteristics was extracted from PH trials registered on ClinicalTrials.gov from 1999 to 2021. A total of 203 eligible clinical PH trials were screened, involving 23,402 participants, 67.8% of whom were females. Major clinical trials were designed to test drug interventions (95.6%), sponsored solely by industries in 59.5%, and targeting Group 1 PH patients in 76.3%. A large number of countries participated in PH clinical trials; however, most clinical trials were conducted in developed countries (84.2%). Developing countries were involved in clinical trials with larger sample sizes (P
doi_str_mv 10.21037/jtd-23-701
format article
fullrecord <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10323586</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2839252336</sourcerecordid><originalsourceid>FETCH-LOGICAL-c340t-4732ed7b3dd9bd79f57c86410ef04cee00c00da3fbb9b4352958e9dc9b5450573</originalsourceid><addsrcrecordid>eNpVUU1Lw0AQXUSxpfbkXXIUJLo7u5vtehEpfhQKguh5STaTdkuaxGxS6L93bWvRucww7_FmeI-QS0ZvgVGu7lZdHgOPFWUnZAhUqThJQJzuZoiZ4HpAxt6vaKiEAih1TgZcCUiYZEMye8eurX2DtnMbjOoqWpR1lpZR05frukrbbbTcNth2WHkXUFu6ytmAd61LS38fMa11DBTYBTkrwgbHhz4in89PH9PXeP72Mps-zmPLBe1ioThgrjKe5zrLlS6kspNEMIoFFRaRUktpnvIiy3QmuAQtJ6hzqzMpJJWKj8jDXrfpszXmFquuTUvTtG4dvjV16sx_pHJLs6g3JtgFXE6SoHB9UGjrrx59Z9bOWyzLtMK69wYmXIMEzn-oN3uqDSb5FovjHUbNLgATAjDATQggsK_-vnbk_trNvwEzD4El</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2839252336</pqid></control><display><type>article</type><title>Retrospective on global pulmonary hypertension clinical trials: 1999-2021</title><source>PubMed Central</source><creator>Zheng, Lu ; Tan, Jun ; Yan, Yi ; Wang, Shang ; Yuan, Ping ; Wu, Cheng ; Zhao, Yin-Tao ; Yang, Hai-Bo ; Nappi, Francesco ; Tonelli, Adriano R ; Wang, Lan ; Hu, Qing-Hua ; Jiang, Rong</creator><creatorcontrib>Zheng, Lu ; Tan, Jun ; Yan, Yi ; Wang, Shang ; Yuan, Ping ; Wu, Cheng ; Zhao, Yin-Tao ; Yang, Hai-Bo ; Nappi, Francesco ; Tonelli, Adriano R ; Wang, Lan ; Hu, Qing-Hua ; Jiang, Rong</creatorcontrib><description>Data are quite sparse on the comprehensive analyses of pulmonary hypertension (PH) clinical trials worldwide. Information including participating countries (developed or developing), intervention type, trial size, PH categories, sponsorship, study phase, design strategies, and participants' demographic characteristics was extracted from PH trials registered on ClinicalTrials.gov from 1999 to 2021. A total of 203 eligible clinical PH trials were screened, involving 23,402 participants, 67.8% of whom were females. Major clinical trials were designed to test drug interventions (95.6%), sponsored solely by industries in 59.5%, and targeting Group 1 PH patients in 76.3%. A large number of countries participated in PH clinical trials; however, most clinical trials were conducted in developed countries (84.2%). Developing countries were involved in clinical trials with larger sample sizes (P&lt;0.01). Additionally, the differences between developed and developing countries centered on interventions, sponsors, PH groups, and design strategies. Furthermore, developing countries participated in multinational clinical trials with good quality, homogeneity, reliability, and data authenticity. All pediatric participants were diagnosed with Group 1 PH and were only involved in drug intervention trials. Children participated in far fewer clinical trials than adults (P&lt;0.01), and most were enrolled in PH clinical trials in developed countries. Among the entire clinical trial population, younger patients with Group 1 PH had a much higher participation to prevalence ratio (PPR). There was no difference in women's PPRs between developed and developing countries. However, developing countries had higher PPRs for PH Groups I and IV (1.28 . 1.22, P&lt;0.01), while developed countries had a lower PPR for Group III (P=0.02). PH is attracting increasing global attention, which is not at the same level of progress in developed and developing countries. Women and children with this disease have unique characteristics and require more attention.</description><identifier>ISSN: 2072-1439</identifier><identifier>EISSN: 2077-6624</identifier><identifier>DOI: 10.21037/jtd-23-701</identifier><identifier>PMID: 37426151</identifier><language>eng</language><publisher>China: AME Publishing Company</publisher><subject>Original</subject><ispartof>Journal of thoracic disease, 2023-06, Vol.15 (6), p.3372-3385</ispartof><rights>2023 Journal of Thoracic Disease. All rights reserved.</rights><rights>2023 Journal of Thoracic Disease. All rights reserved. 2023 Journal of Thoracic Disease.</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10323586/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10323586/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,733,786,790,891,27957,27958,53827,53829</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37426151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zheng, Lu</creatorcontrib><creatorcontrib>Tan, Jun</creatorcontrib><creatorcontrib>Yan, Yi</creatorcontrib><creatorcontrib>Wang, Shang</creatorcontrib><creatorcontrib>Yuan, Ping</creatorcontrib><creatorcontrib>Wu, Cheng</creatorcontrib><creatorcontrib>Zhao, Yin-Tao</creatorcontrib><creatorcontrib>Yang, Hai-Bo</creatorcontrib><creatorcontrib>Nappi, Francesco</creatorcontrib><creatorcontrib>Tonelli, Adriano R</creatorcontrib><creatorcontrib>Wang, Lan</creatorcontrib><creatorcontrib>Hu, Qing-Hua</creatorcontrib><creatorcontrib>Jiang, Rong</creatorcontrib><title>Retrospective on global pulmonary hypertension clinical trials: 1999-2021</title><title>Journal of thoracic disease</title><addtitle>J Thorac Dis</addtitle><description>Data are quite sparse on the comprehensive analyses of pulmonary hypertension (PH) clinical trials worldwide. Information including participating countries (developed or developing), intervention type, trial size, PH categories, sponsorship, study phase, design strategies, and participants' demographic characteristics was extracted from PH trials registered on ClinicalTrials.gov from 1999 to 2021. A total of 203 eligible clinical PH trials were screened, involving 23,402 participants, 67.8% of whom were females. Major clinical trials were designed to test drug interventions (95.6%), sponsored solely by industries in 59.5%, and targeting Group 1 PH patients in 76.3%. A large number of countries participated in PH clinical trials; however, most clinical trials were conducted in developed countries (84.2%). Developing countries were involved in clinical trials with larger sample sizes (P&lt;0.01). Additionally, the differences between developed and developing countries centered on interventions, sponsors, PH groups, and design strategies. Furthermore, developing countries participated in multinational clinical trials with good quality, homogeneity, reliability, and data authenticity. All pediatric participants were diagnosed with Group 1 PH and were only involved in drug intervention trials. Children participated in far fewer clinical trials than adults (P&lt;0.01), and most were enrolled in PH clinical trials in developed countries. Among the entire clinical trial population, younger patients with Group 1 PH had a much higher participation to prevalence ratio (PPR). There was no difference in women's PPRs between developed and developing countries. However, developing countries had higher PPRs for PH Groups I and IV (1.28 . 1.22, P&lt;0.01), while developed countries had a lower PPR for Group III (P=0.02). PH is attracting increasing global attention, which is not at the same level of progress in developed and developing countries. Women and children with this disease have unique characteristics and require more attention.</description><subject>Original</subject><issn>2072-1439</issn><issn>2077-6624</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNpVUU1Lw0AQXUSxpfbkXXIUJLo7u5vtehEpfhQKguh5STaTdkuaxGxS6L93bWvRucww7_FmeI-QS0ZvgVGu7lZdHgOPFWUnZAhUqThJQJzuZoiZ4HpAxt6vaKiEAih1TgZcCUiYZEMye8eurX2DtnMbjOoqWpR1lpZR05frukrbbbTcNth2WHkXUFu6ytmAd61LS38fMa11DBTYBTkrwgbHhz4in89PH9PXeP72Mps-zmPLBe1ioThgrjKe5zrLlS6kspNEMIoFFRaRUktpnvIiy3QmuAQtJ6hzqzMpJJWKj8jDXrfpszXmFquuTUvTtG4dvjV16sx_pHJLs6g3JtgFXE6SoHB9UGjrrx59Z9bOWyzLtMK69wYmXIMEzn-oN3uqDSb5FovjHUbNLgATAjDATQggsK_-vnbk_trNvwEzD4El</recordid><startdate>20230601</startdate><enddate>20230601</enddate><creator>Zheng, Lu</creator><creator>Tan, Jun</creator><creator>Yan, Yi</creator><creator>Wang, Shang</creator><creator>Yuan, Ping</creator><creator>Wu, Cheng</creator><creator>Zhao, Yin-Tao</creator><creator>Yang, Hai-Bo</creator><creator>Nappi, Francesco</creator><creator>Tonelli, Adriano R</creator><creator>Wang, Lan</creator><creator>Hu, Qing-Hua</creator><creator>Jiang, Rong</creator><general>AME Publishing Company</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20230601</creationdate><title>Retrospective on global pulmonary hypertension clinical trials: 1999-2021</title><author>Zheng, Lu ; Tan, Jun ; Yan, Yi ; Wang, Shang ; Yuan, Ping ; Wu, Cheng ; Zhao, Yin-Tao ; Yang, Hai-Bo ; Nappi, Francesco ; Tonelli, Adriano R ; Wang, Lan ; Hu, Qing-Hua ; Jiang, Rong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c340t-4732ed7b3dd9bd79f57c86410ef04cee00c00da3fbb9b4352958e9dc9b5450573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Original</topic><toplevel>online_resources</toplevel><creatorcontrib>Zheng, Lu</creatorcontrib><creatorcontrib>Tan, Jun</creatorcontrib><creatorcontrib>Yan, Yi</creatorcontrib><creatorcontrib>Wang, Shang</creatorcontrib><creatorcontrib>Yuan, Ping</creatorcontrib><creatorcontrib>Wu, Cheng</creatorcontrib><creatorcontrib>Zhao, Yin-Tao</creatorcontrib><creatorcontrib>Yang, Hai-Bo</creatorcontrib><creatorcontrib>Nappi, Francesco</creatorcontrib><creatorcontrib>Tonelli, Adriano R</creatorcontrib><creatorcontrib>Wang, Lan</creatorcontrib><creatorcontrib>Hu, Qing-Hua</creatorcontrib><creatorcontrib>Jiang, Rong</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of thoracic disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zheng, Lu</au><au>Tan, Jun</au><au>Yan, Yi</au><au>Wang, Shang</au><au>Yuan, Ping</au><au>Wu, Cheng</au><au>Zhao, Yin-Tao</au><au>Yang, Hai-Bo</au><au>Nappi, Francesco</au><au>Tonelli, Adriano R</au><au>Wang, Lan</au><au>Hu, Qing-Hua</au><au>Jiang, Rong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Retrospective on global pulmonary hypertension clinical trials: 1999-2021</atitle><jtitle>Journal of thoracic disease</jtitle><addtitle>J Thorac Dis</addtitle><date>2023-06-01</date><risdate>2023</risdate><volume>15</volume><issue>6</issue><spage>3372</spage><epage>3385</epage><pages>3372-3385</pages><issn>2072-1439</issn><eissn>2077-6624</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>Contributions: (I) Conception and design: L Zheng, Y Yan, R Jiang; (II) Administrative support: L Wang; (III) Provision of study materials or patients: S Wang, P Yuan; (IV) Collection and assembly of data: J Tan, L Zheng; (V) Data analysis and interpretation: R Jiang, C Wu, YT Zhao, QH Hu, HB Yang; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.</notes><notes>These authors contributed equally to this work and should be considered as co-first authors.</notes><abstract>Data are quite sparse on the comprehensive analyses of pulmonary hypertension (PH) clinical trials worldwide. Information including participating countries (developed or developing), intervention type, trial size, PH categories, sponsorship, study phase, design strategies, and participants' demographic characteristics was extracted from PH trials registered on ClinicalTrials.gov from 1999 to 2021. A total of 203 eligible clinical PH trials were screened, involving 23,402 participants, 67.8% of whom were females. Major clinical trials were designed to test drug interventions (95.6%), sponsored solely by industries in 59.5%, and targeting Group 1 PH patients in 76.3%. A large number of countries participated in PH clinical trials; however, most clinical trials were conducted in developed countries (84.2%). Developing countries were involved in clinical trials with larger sample sizes (P&lt;0.01). Additionally, the differences between developed and developing countries centered on interventions, sponsors, PH groups, and design strategies. Furthermore, developing countries participated in multinational clinical trials with good quality, homogeneity, reliability, and data authenticity. All pediatric participants were diagnosed with Group 1 PH and were only involved in drug intervention trials. Children participated in far fewer clinical trials than adults (P&lt;0.01), and most were enrolled in PH clinical trials in developed countries. Among the entire clinical trial population, younger patients with Group 1 PH had a much higher participation to prevalence ratio (PPR). There was no difference in women's PPRs between developed and developing countries. However, developing countries had higher PPRs for PH Groups I and IV (1.28 . 1.22, P&lt;0.01), while developed countries had a lower PPR for Group III (P=0.02). PH is attracting increasing global attention, which is not at the same level of progress in developed and developing countries. Women and children with this disease have unique characteristics and require more attention.</abstract><cop>China</cop><pub>AME Publishing Company</pub><pmid>37426151</pmid><doi>10.21037/jtd-23-701</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 2072-1439
ispartof Journal of thoracic disease, 2023-06, Vol.15 (6), p.3372-3385
issn 2072-1439
2077-6624
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10323586
source PubMed Central
subjects Original
title Retrospective on global pulmonary hypertension clinical trials: 1999-2021
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-09-30T16%3A40%3A46IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Retrospective%20on%20global%20pulmonary%20hypertension%20clinical%20trials:%201999-2021&rft.jtitle=Journal%20of%20thoracic%20disease&rft.au=Zheng,%20Lu&rft.date=2023-06-01&rft.volume=15&rft.issue=6&rft.spage=3372&rft.epage=3385&rft.pages=3372-3385&rft.issn=2072-1439&rft.eissn=2077-6624&rft_id=info:doi/10.21037/jtd-23-701&rft_dat=%3Cproquest_pubme%3E2839252336%3C/proquest_pubme%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c340t-4732ed7b3dd9bd79f57c86410ef04cee00c00da3fbb9b4352958e9dc9b5450573%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2839252336&rft_id=info:pmid/37426151&rfr_iscdi=true