Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation
Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA)...
Gespeichert in:
| Veröffentlicht in: | Journal of clinical epidemiology 2024-03, Vol.167, p.111263-111263, Article 111263 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 111263 |
|---|---|
| container_issue | |
| container_start_page | 111263 |
| container_title | Journal of clinical epidemiology |
| container_volume | 167 |
| creator | Hopkins, Ashley M. Modi, Natansh D. Rockhold, Frank W. Hoffmann, Tammy Menz, Bradley D. Veroniki, Areti-Angeliki McKinnon, Ross A. Rowland, Andrew Swain, Sandra M. Ross, Joseph S. Sorich, Michael J. |
| description | Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.
This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors’ data sharing policies.
There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor.
CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor. |
| doi_str_mv | 10.1016/j.jclinepi.2024.111263 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2914254828</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0895435624000180</els_id><sourcerecordid>2914254828</sourcerecordid><originalsourceid>FETCH-LOGICAL-c444t-fadcdab958a735f05d8b2c6fbc62524ce9ded110a77382b63cdc95594d19ab733</originalsourceid><addsrcrecordid>eNqFkctO3DAUhq2qqEyBV0CR2LDJ1MeXxGZVhHqTkLqBteUcO8hRJgl2gjRv02fhyeow0AWbrmzL338u_0_IOdAtUKi-dNsO-zD4KWwZZWILAKziH8gGVK1KqRl8JBuqtCwFl9Ux-ZxSRynUtJafyDFXDLQCuiHuGtGnFJrQh3lfjG2xlg1o-yLNi9sX0U9jnFORlmm9hOGh2HkXMPcu7DTF8cn26aqwz38wjimVyeMcxiHrff5Z7Po4JUdtpvzZ63lC7r9_u7v5Wd7-_vHr5vq2RCHEXLbWobONlsrWXLZUOtUwrNoGKyaZQK-ddwDU1nVeoKk4OtRSauFA26bm_IRcHurmsR4Xn2azCwl939vBj0syTINgUiimMnrxDu3GJeaxV6rmwKmQLFPVgXrZLfrWTDHsbNwboGbNwXTmLQez5mAOOWTh-Wv5pcl2_ZO9GZ-BrwfAZz-ego8mYfADZmtjdtC4Mfyvx18d6p9v</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2973130452</pqid></control><display><type>article</type><title>Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation</title><source>Elsevier ScienceDirect Journals</source><creator>Hopkins, Ashley M. ; Modi, Natansh D. ; Rockhold, Frank W. ; Hoffmann, Tammy ; Menz, Bradley D. ; Veroniki, Areti-Angeliki ; McKinnon, Ross A. ; Rowland, Andrew ; Swain, Sandra M. ; Ross, Joseph S. ; Sorich, Michael J.</creator><creatorcontrib>Hopkins, Ashley M. ; Modi, Natansh D. ; Rockhold, Frank W. ; Hoffmann, Tammy ; Menz, Bradley D. ; Veroniki, Areti-Angeliki ; McKinnon, Ross A. ; Rowland, Andrew ; Swain, Sandra M. ; Ross, Joseph S. ; Sorich, Michael J.</creatorcontrib><description>Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.
This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors’ data sharing policies.
There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor.
CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.</description><identifier>ISSN: 0895-4356</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/j.jclinepi.2024.111263</identifier><identifier>PMID: 38219810</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Accessibility ; Binomial distribution ; Blockbuster medicines ; Cancer ; Clinical study reports ; Clinical trial transparency ; Clinical trials ; Corporate sponsorship ; Data sharing ; Data transparency ; Downloading ; FDA approval ; Federal regulation ; Industry sponsored trials ; Information sharing ; Labels ; Medical research ; Medicine ; Pharmaceutical industry ; Regulatory agencies ; Regulatory decision transparency ; Repositories ; Researchers</subject><ispartof>Journal of clinical epidemiology, 2024-03, Vol.167, p.111263-111263, Article 111263</ispartof><rights>2024</rights><rights>Crown Copyright © 2024. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Mar 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c444t-fadcdab958a735f05d8b2c6fbc62524ce9ded110a77382b63cdc95594d19ab733</citedby><cites>FETCH-LOGICAL-c444t-fadcdab958a735f05d8b2c6fbc62524ce9ded110a77382b63cdc95594d19ab733</cites><orcidid>0000-0001-5210-8548 ; 0000-0003-3732-4765 ; 0000-0002-9218-3320 ; 0000-0002-3725-793X ; 0000-0003-3262-5374 ; 0000-0001-7652-4378 ; 0000-0002-0855-5081</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0895435624000180$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38219810$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hopkins, Ashley M.</creatorcontrib><creatorcontrib>Modi, Natansh D.</creatorcontrib><creatorcontrib>Rockhold, Frank W.</creatorcontrib><creatorcontrib>Hoffmann, Tammy</creatorcontrib><creatorcontrib>Menz, Bradley D.</creatorcontrib><creatorcontrib>Veroniki, Areti-Angeliki</creatorcontrib><creatorcontrib>McKinnon, Ross A.</creatorcontrib><creatorcontrib>Rowland, Andrew</creatorcontrib><creatorcontrib>Swain, Sandra M.</creatorcontrib><creatorcontrib>Ross, Joseph S.</creatorcontrib><creatorcontrib>Sorich, Michael J.</creatorcontrib><title>Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.
This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors’ data sharing policies.
There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor.
CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.</description><subject>Accessibility</subject><subject>Binomial distribution</subject><subject>Blockbuster medicines</subject><subject>Cancer</subject><subject>Clinical study reports</subject><subject>Clinical trial transparency</subject><subject>Clinical trials</subject><subject>Corporate sponsorship</subject><subject>Data sharing</subject><subject>Data transparency</subject><subject>Downloading</subject><subject>FDA approval</subject><subject>Federal regulation</subject><subject>Industry sponsored trials</subject><subject>Information sharing</subject><subject>Labels</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Pharmaceutical industry</subject><subject>Regulatory agencies</subject><subject>Regulatory decision transparency</subject><subject>Repositories</subject><subject>Researchers</subject><issn>0895-4356</issn><issn>1878-5921</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkctO3DAUhq2qqEyBV0CR2LDJ1MeXxGZVhHqTkLqBteUcO8hRJgl2gjRv02fhyeow0AWbrmzL338u_0_IOdAtUKi-dNsO-zD4KWwZZWILAKziH8gGVK1KqRl8JBuqtCwFl9Ux-ZxSRynUtJafyDFXDLQCuiHuGtGnFJrQh3lfjG2xlg1o-yLNi9sX0U9jnFORlmm9hOGh2HkXMPcu7DTF8cn26aqwz38wjimVyeMcxiHrff5Z7Po4JUdtpvzZ63lC7r9_u7v5Wd7-_vHr5vq2RCHEXLbWobONlsrWXLZUOtUwrNoGKyaZQK-ddwDU1nVeoKk4OtRSauFA26bm_IRcHurmsR4Xn2azCwl939vBj0syTINgUiimMnrxDu3GJeaxV6rmwKmQLFPVgXrZLfrWTDHsbNwboGbNwXTmLQez5mAOOWTh-Wv5pcl2_ZO9GZ-BrwfAZz-ego8mYfADZmtjdtC4Mfyvx18d6p9v</recordid><startdate>202403</startdate><enddate>202403</enddate><creator>Hopkins, Ashley M.</creator><creator>Modi, Natansh D.</creator><creator>Rockhold, Frank W.</creator><creator>Hoffmann, Tammy</creator><creator>Menz, Bradley D.</creator><creator>Veroniki, Areti-Angeliki</creator><creator>McKinnon, Ross A.</creator><creator>Rowland, Andrew</creator><creator>Swain, Sandra M.</creator><creator>Ross, Joseph S.</creator><creator>Sorich, Michael J.</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7T2</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5210-8548</orcidid><orcidid>https://orcid.org/0000-0003-3732-4765</orcidid><orcidid>https://orcid.org/0000-0002-9218-3320</orcidid><orcidid>https://orcid.org/0000-0002-3725-793X</orcidid><orcidid>https://orcid.org/0000-0003-3262-5374</orcidid><orcidid>https://orcid.org/0000-0001-7652-4378</orcidid><orcidid>https://orcid.org/0000-0002-0855-5081</orcidid></search><sort><creationdate>202403</creationdate><title>Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation</title><author>Hopkins, Ashley M. ; Modi, Natansh D. ; Rockhold, Frank W. ; Hoffmann, Tammy ; Menz, Bradley D. ; Veroniki, Areti-Angeliki ; McKinnon, Ross A. ; Rowland, Andrew ; Swain, Sandra M. ; Ross, Joseph S. ; Sorich, Michael J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c444t-fadcdab958a735f05d8b2c6fbc62524ce9ded110a77382b63cdc95594d19ab733</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Accessibility</topic><topic>Binomial distribution</topic><topic>Blockbuster medicines</topic><topic>Cancer</topic><topic>Clinical study reports</topic><topic>Clinical trial transparency</topic><topic>Clinical trials</topic><topic>Corporate sponsorship</topic><topic>Data sharing</topic><topic>Data transparency</topic><topic>Downloading</topic><topic>FDA approval</topic><topic>Federal regulation</topic><topic>Industry sponsored trials</topic><topic>Information sharing</topic><topic>Labels</topic><topic>Medical research</topic><topic>Medicine</topic><topic>Pharmaceutical industry</topic><topic>Regulatory agencies</topic><topic>Regulatory decision transparency</topic><topic>Repositories</topic><topic>Researchers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hopkins, Ashley M.</creatorcontrib><creatorcontrib>Modi, Natansh D.</creatorcontrib><creatorcontrib>Rockhold, Frank W.</creatorcontrib><creatorcontrib>Hoffmann, Tammy</creatorcontrib><creatorcontrib>Menz, Bradley D.</creatorcontrib><creatorcontrib>Veroniki, Areti-Angeliki</creatorcontrib><creatorcontrib>McKinnon, Ross A.</creatorcontrib><creatorcontrib>Rowland, Andrew</creatorcontrib><creatorcontrib>Swain, Sandra M.</creatorcontrib><creatorcontrib>Ross, Joseph S.</creatorcontrib><creatorcontrib>Sorich, Michael J.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hopkins, Ashley M.</au><au>Modi, Natansh D.</au><au>Rockhold, Frank W.</au><au>Hoffmann, Tammy</au><au>Menz, Bradley D.</au><au>Veroniki, Areti-Angeliki</au><au>McKinnon, Ross A.</au><au>Rowland, Andrew</au><au>Swain, Sandra M.</au><au>Ross, Joseph S.</au><au>Sorich, Michael J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2024-03</date><risdate>2024</risdate><volume>167</volume><spage>111263</spage><epage>111263</epage><pages>111263-111263</pages><artnum>111263</artnum><issn>0895-4356</issn><eissn>1878-5921</eissn><abstract>Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.
This cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors’ data sharing policies.
There were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor.
CSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38219810</pmid><doi>10.1016/j.jclinepi.2024.111263</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-5210-8548</orcidid><orcidid>https://orcid.org/0000-0003-3732-4765</orcidid><orcidid>https://orcid.org/0000-0002-9218-3320</orcidid><orcidid>https://orcid.org/0000-0002-3725-793X</orcidid><orcidid>https://orcid.org/0000-0003-3262-5374</orcidid><orcidid>https://orcid.org/0000-0001-7652-4378</orcidid><orcidid>https://orcid.org/0000-0002-0855-5081</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0895-4356 |
| ispartof | Journal of clinical epidemiology, 2024-03, Vol.167, p.111263-111263, Article 111263 |
| issn | 0895-4356 1878-5921 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2914254828 |
| source | Elsevier ScienceDirect Journals |
| subjects | Accessibility Binomial distribution Blockbuster medicines Cancer Clinical study reports Clinical trial transparency Clinical trials Corporate sponsorship Data sharing Data transparency Downloading FDA approval Federal regulation Industry sponsored trials Information sharing Labels Medical research Medicine Pharmaceutical industry Regulatory agencies Regulatory decision transparency Repositories Researchers |
| title | Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T21%3A56%3A37IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Accessibility%20of%20clinical%20study%20reports%20supporting%20medicine%20approvals:%20a%C2%A0cross-sectional%20evaluation&rft.jtitle=Journal%20of%20clinical%20epidemiology&rft.au=Hopkins,%20Ashley%20M.&rft.date=2024-03&rft.volume=167&rft.spage=111263&rft.epage=111263&rft.pages=111263-111263&rft.artnum=111263&rft.issn=0895-4356&rft.eissn=1878-5921&rft_id=info:doi/10.1016/j.jclinepi.2024.111263&rft_dat=%3Cproquest_cross%3E2914254828%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2973130452&rft_id=info:pmid/38219810&rft_els_id=S0895435624000180&rfr_iscdi=true |