Loading…

Prospectively shared control data across concurrent randomised clinical trials

Sharing data from control groups across concurrent randomised clinical trials with identical enrolment criteria and the same control therapy can translate into efficiencies for the drug development process. We discuss potential benefits and risks of prospective data-sharing plans for concurrent rand...

Full description

Saved in:
Bibliographic Details
Published in:European journal of cancer (1990) 2023-03, Vol.181, p.18-20
Main Authors: Kotecha, Gopal, Ventz, Steffen, Trippa, Lorenzo
Format: Article
Language:English
Subjects:
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933
cites cdi_FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933
container_end_page 20
container_issue
container_start_page 18
container_title European journal of cancer (1990)
container_volume 181
creator Kotecha, Gopal
Ventz, Steffen
Trippa, Lorenzo
description Sharing data from control groups across concurrent randomised clinical trials with identical enrolment criteria and the same control therapy can translate into efficiencies for the drug development process. We discuss potential benefits and risks of prospective data-sharing plans for concurrent randomised trials. •The current trial landscape consists of independent trials that do not share data.•There is a need for trial designs to improve drug development efficiency.•We propose sharing control arm data between concurrent randomised trials.•This represents a sweet spot between existing approaches with limited risks of bias.•Simulations based on data from glioblastoma confirm the benefits of this approach.
doi_str_mv 10.1016/j.ejca.2022.11.038
format article
fullrecord <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9925400</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0959804922017890</els_id><sourcerecordid>2762817831</sourcerecordid><originalsourceid>FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933</originalsourceid><addsrcrecordid>eNp9kUGL1TAQx4Mo7tvVL-BBCl68tM4kTZOACLK4KizqQc8hTVI3pa95Ju2D_famvnVRD54Gkt_8mZkfIc8QGgTsXo2NH61pKFDaIDbA5AOyQylUDZLTh2QHiqtaQqvOyHnOIwAI2cJjcsa6jiKi2JFPX1LMB2-XcPTTbZVvTPKusnFeUpwqZxZTGVuQvL3ZNSU_L1Uys4v7kDdyCnOwZqqWFMyUn5BHQyn-6V29IN-u3n29_FBff37_8fLtdW1bZEvNheRo2CCU6oYW-77r3ABOUWt6hwOlznMveyd46wcLgkI3GBDAgLXcKcYuyJtT7mHt997ZMlUykz6ksDfpVkcT9N8_c7jR3-NRK0V5C1ACXt4FpPhj9XnRZR_rp8nMPq5ZU9FRiUIyLOiLf9Axrmku6xVKcd5y1slC0RP161rJD_fDIOhNlx71pktvujSiLrpK0_M_17hv-e2nAK9PgC_HPAafdLbBz9a7kIo07WL4X_5PkvWnyw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2795545368</pqid></control><display><type>article</type><title>Prospectively shared control data across concurrent randomised clinical trials</title><source>ScienceDirect Freedom Collection</source><creator>Kotecha, Gopal ; Ventz, Steffen ; Trippa, Lorenzo</creator><creatorcontrib>Kotecha, Gopal ; Ventz, Steffen ; Trippa, Lorenzo</creatorcontrib><description>Sharing data from control groups across concurrent randomised clinical trials with identical enrolment criteria and the same control therapy can translate into efficiencies for the drug development process. We discuss potential benefits and risks of prospective data-sharing plans for concurrent randomised trials. •The current trial landscape consists of independent trials that do not share data.•There is a need for trial designs to improve drug development efficiency.•We propose sharing control arm data between concurrent randomised trials.•This represents a sweet spot between existing approaches with limited risks of bias.•Simulations based on data from glioblastoma confirm the benefits of this approach.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2022.11.038</identifier><identifier>PMID: 36621117</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Clinical trials ; Control data (computers) ; Data sharing ; Drug development ; Humans ; Prospective Studies ; Trial design</subject><ispartof>European journal of cancer (1990), 2023-03, Vol.181, p.18-20</ispartof><rights>2022 Elsevier Ltd</rights><rights>Copyright © 2022 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Mar 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933</citedby><cites>FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933</cites><orcidid>0000-0002-6768-1221</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36621117$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kotecha, Gopal</creatorcontrib><creatorcontrib>Ventz, Steffen</creatorcontrib><creatorcontrib>Trippa, Lorenzo</creatorcontrib><title>Prospectively shared control data across concurrent randomised clinical trials</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Sharing data from control groups across concurrent randomised clinical trials with identical enrolment criteria and the same control therapy can translate into efficiencies for the drug development process. We discuss potential benefits and risks of prospective data-sharing plans for concurrent randomised trials. •The current trial landscape consists of independent trials that do not share data.•There is a need for trial designs to improve drug development efficiency.•We propose sharing control arm data between concurrent randomised trials.•This represents a sweet spot between existing approaches with limited risks of bias.•Simulations based on data from glioblastoma confirm the benefits of this approach.</description><subject>Clinical trials</subject><subject>Control data (computers)</subject><subject>Data sharing</subject><subject>Drug development</subject><subject>Humans</subject><subject>Prospective Studies</subject><subject>Trial design</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kUGL1TAQx4Mo7tvVL-BBCl68tM4kTZOACLK4KizqQc8hTVI3pa95Ju2D_famvnVRD54Gkt_8mZkfIc8QGgTsXo2NH61pKFDaIDbA5AOyQylUDZLTh2QHiqtaQqvOyHnOIwAI2cJjcsa6jiKi2JFPX1LMB2-XcPTTbZVvTPKusnFeUpwqZxZTGVuQvL3ZNSU_L1Uys4v7kDdyCnOwZqqWFMyUn5BHQyn-6V29IN-u3n29_FBff37_8fLtdW1bZEvNheRo2CCU6oYW-77r3ABOUWt6hwOlznMveyd46wcLgkI3GBDAgLXcKcYuyJtT7mHt997ZMlUykz6ksDfpVkcT9N8_c7jR3-NRK0V5C1ACXt4FpPhj9XnRZR_rp8nMPq5ZU9FRiUIyLOiLf9Axrmku6xVKcd5y1slC0RP161rJD_fDIOhNlx71pktvujSiLrpK0_M_17hv-e2nAK9PgC_HPAafdLbBz9a7kIo07WL4X_5PkvWnyw</recordid><startdate>20230301</startdate><enddate>20230301</enddate><creator>Kotecha, Gopal</creator><creator>Ventz, Steffen</creator><creator>Trippa, Lorenzo</creator><general>Elsevier Ltd</general><general>Elsevier Science Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6768-1221</orcidid></search><sort><creationdate>20230301</creationdate><title>Prospectively shared control data across concurrent randomised clinical trials</title><author>Kotecha, Gopal ; Ventz, Steffen ; Trippa, Lorenzo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Clinical trials</topic><topic>Control data (computers)</topic><topic>Data sharing</topic><topic>Drug development</topic><topic>Humans</topic><topic>Prospective Studies</topic><topic>Trial design</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kotecha, Gopal</creatorcontrib><creatorcontrib>Ventz, Steffen</creatorcontrib><creatorcontrib>Trippa, Lorenzo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kotecha, Gopal</au><au>Ventz, Steffen</au><au>Trippa, Lorenzo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospectively shared control data across concurrent randomised clinical trials</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2023-03-01</date><risdate>2023</risdate><volume>181</volume><spage>18</spage><epage>20</epage><pages>18-20</pages><issn>0959-8049</issn><eissn>1879-0852</eissn><abstract>Sharing data from control groups across concurrent randomised clinical trials with identical enrolment criteria and the same control therapy can translate into efficiencies for the drug development process. We discuss potential benefits and risks of prospective data-sharing plans for concurrent randomised trials. •The current trial landscape consists of independent trials that do not share data.•There is a need for trial designs to improve drug development efficiency.•We propose sharing control arm data between concurrent randomised trials.•This represents a sweet spot between existing approaches with limited risks of bias.•Simulations based on data from glioblastoma confirm the benefits of this approach.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>36621117</pmid><doi>10.1016/j.ejca.2022.11.038</doi><tpages>3</tpages><orcidid>https://orcid.org/0000-0002-6768-1221</orcidid><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 0959-8049
ispartof European journal of cancer (1990), 2023-03, Vol.181, p.18-20
issn 0959-8049
1879-0852
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9925400
source ScienceDirect Freedom Collection
subjects Clinical trials
Control data (computers)
Data sharing
Drug development
Humans
Prospective Studies
Trial design
title Prospectively shared control data across concurrent randomised clinical trials
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-26T07%3A41%3A27IST&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=Prospectively%20shared%20control%20data%20across%20concurrent%20randomised%20clinical%20trials&rft.jtitle=European%20journal%20of%20cancer%20(1990)&rft.au=Kotecha,%20Gopal&rft.date=2023-03-01&rft.volume=181&rft.spage=18&rft.epage=20&rft.pages=18-20&rft.issn=0959-8049&rft.eissn=1879-0852&rft_id=info:doi/10.1016/j.ejca.2022.11.038&rft_dat=%3Cproquest_pubme%3E2762817831%3C/proquest_pubme%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c413t-57851a3f7996f41bb66df0d92cabd1f22de5e8bd754efc07206fa07030345d933%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2795545368&rft_id=info:pmid/36621117&rfr_iscdi=true