Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey
Abstract Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or effica...
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creator | Flacco, Maria Elena, MD Manzoli, Lamberto, MD, MPH Boccia, Stefania, MD, PhD Puggina, Anna, MD Rosso, Annalisa, MD, MPH Marzuillo, Carolina, MD Scaioli, Giacomo, MD Gualano, Maria Rosaria, MD Ricciardi, Walter, MD, MPH Villari, Paolo, MD, MPH Ioannidis, John P.A., MD, PhD |
description | Abstract Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories (“inbred” if the compared drugs were owned by the same company or its partners/subsidiaries, “competitive” if the compared drugs were owned by competing companies, and “apparently nonprofit”), and time to publication was evaluated with Cox analysis. Results We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials ( P =.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). Conclusion Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed. |
doi_str_mv | 10.1016/j.mayocp.2016.04.032 |
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fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1809606705</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A462046105</galeid><els_id>1_s2_0_S0025619616302701</els_id><sourcerecordid>A462046105</sourcerecordid><originalsourceid>FETCH-LOGICAL-c476t-ef6fffe6a8098897f5dbc4bb5bb31d0a041b92ca9420140605fbf659d251ce7c3</originalsourceid><addsrcrecordid>eNqFkk1v1DAQhi0EotvCP0AoEhLikjB2bGfDodKyhYJUQGrL2XKc8dZLEi92Umn59XibAlIvXPwhP_POjN8h5AWFggKVb7dFr_fe7AqWbgXwAkr2iCxozVkuBJePyQKAiVzSWh6R4xi3AFDVNX9KjljF09OyXJAvl7hxccSAbXaph9b37lc6Xgenu5itfb_TwQ2b7BwHDM5kCcneh7TmX3WP2VmYNvFdtsqupnCL-2fkiU1x-Px-PyHfP364Xn_KL76df16vLnLDKznmaKW1FqVeQr1c1pUVbWN404imKWkLGjhtamZ0agUoBwnCNlaKumWCGqxMeULezLq74H9OGEfVu2iw6_SAfoqKJmEJsgKR0FcP0K2fwpCqu6OoELVgiXo9UxvdobpB3Y030XfT6PwQ1YpLBlzSOzk-gyb4GANatQuu12GvKKiDL2qrZl_UwRcFXCVfUtjL-yqmpsf2b9AfIxJwOgOYvu3WYVDROBwMti6gGVXr3f8yPBQwnRuc0d0P3GP817SKTIG6OszGYTSoLIFVQMvfufiy4w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1809155952</pqid></control><display><type>article</type><title>Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Flacco, Maria Elena, MD ; Manzoli, Lamberto, MD, MPH ; Boccia, Stefania, MD, PhD ; Puggina, Anna, MD ; Rosso, Annalisa, MD, MPH ; Marzuillo, Carolina, MD ; Scaioli, Giacomo, MD ; Gualano, Maria Rosaria, MD ; Ricciardi, Walter, MD, MPH ; Villari, Paolo, MD, MPH ; Ioannidis, John P.A., MD, PhD</creator><creatorcontrib>Flacco, Maria Elena, MD ; Manzoli, Lamberto, MD, MPH ; Boccia, Stefania, MD, PhD ; Puggina, Anna, MD ; Rosso, Annalisa, MD, MPH ; Marzuillo, Carolina, MD ; Scaioli, Giacomo, MD ; Gualano, Maria Rosaria, MD ; Ricciardi, Walter, MD, MPH ; Villari, Paolo, MD, MPH ; Ioannidis, John P.A., MD, PhD</creatorcontrib><description>Abstract Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories (“inbred” if the compared drugs were owned by the same company or its partners/subsidiaries, “competitive” if the compared drugs were owned by competing companies, and “apparently nonprofit”), and time to publication was evaluated with Cox analysis. Results We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials ( P =.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). Conclusion Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.</description><identifier>ISSN: 0025-6196</identifier><identifier>EISSN: 1942-5546</identifier><identifier>DOI: 10.1016/j.mayocp.2016.04.032</identifier><identifier>PMID: 27402583</identifier><identifier>CODEN: MACPAJ</identifier><language>eng</language><publisher>England: Elsevier Inc</publisher><subject>Analysis ; Clinical trials ; Data Mining ; Databases, Factual - statistics & numerical data ; Drugs, Generic - pharmacokinetics ; Generic drugs ; Humans ; Internal Medicine ; Prescription Drugs - classification ; Prescription Drugs - pharmacokinetics ; Publications - statistics & numerical data ; Randomized Controlled Trials as Topic - statistics & numerical data ; Registries ; Surveys ; Surveys and Questionnaires ; Therapeutic Equivalency</subject><ispartof>Mayo Clinic proceedings, 2016-08, Vol.91 (8), p.1021-1034</ispartof><rights>Mayo Foundation for Medical Education and Research</rights><rights>2016 Mayo Foundation for Medical Education and Research</rights><rights>Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.</rights><rights>COPYRIGHT 2016 Frontline Medical Communications Inc.</rights><rights>Copyright Mayo Foundation for Medical Education and Research Aug 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c476t-ef6fffe6a8098897f5dbc4bb5bb31d0a041b92ca9420140605fbf659d251ce7c3</citedby><cites>FETCH-LOGICAL-c476t-ef6fffe6a8098897f5dbc4bb5bb31d0a041b92ca9420140605fbf659d251ce7c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27402583$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Flacco, Maria Elena, MD</creatorcontrib><creatorcontrib>Manzoli, Lamberto, MD, MPH</creatorcontrib><creatorcontrib>Boccia, Stefania, MD, PhD</creatorcontrib><creatorcontrib>Puggina, Anna, MD</creatorcontrib><creatorcontrib>Rosso, Annalisa, MD, MPH</creatorcontrib><creatorcontrib>Marzuillo, Carolina, MD</creatorcontrib><creatorcontrib>Scaioli, Giacomo, MD</creatorcontrib><creatorcontrib>Gualano, Maria Rosaria, MD</creatorcontrib><creatorcontrib>Ricciardi, Walter, MD, MPH</creatorcontrib><creatorcontrib>Villari, Paolo, MD, MPH</creatorcontrib><creatorcontrib>Ioannidis, John P.A., MD, PhD</creatorcontrib><title>Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey</title><title>Mayo Clinic proceedings</title><addtitle>Mayo Clin Proc</addtitle><description>Abstract Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories (“inbred” if the compared drugs were owned by the same company or its partners/subsidiaries, “competitive” if the compared drugs were owned by competing companies, and “apparently nonprofit”), and time to publication was evaluated with Cox analysis. Results We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials ( P =.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). Conclusion Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.</description><subject>Analysis</subject><subject>Clinical trials</subject><subject>Data Mining</subject><subject>Databases, Factual - statistics & numerical data</subject><subject>Drugs, Generic - pharmacokinetics</subject><subject>Generic drugs</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Prescription Drugs - classification</subject><subject>Prescription Drugs - pharmacokinetics</subject><subject>Publications - statistics & numerical data</subject><subject>Randomized Controlled Trials as Topic - statistics & numerical data</subject><subject>Registries</subject><subject>Surveys</subject><subject>Surveys and Questionnaires</subject><subject>Therapeutic Equivalency</subject><issn>0025-6196</issn><issn>1942-5546</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkk1v1DAQhi0EotvCP0AoEhLikjB2bGfDodKyhYJUQGrL2XKc8dZLEi92Umn59XibAlIvXPwhP_POjN8h5AWFggKVb7dFr_fe7AqWbgXwAkr2iCxozVkuBJePyQKAiVzSWh6R4xi3AFDVNX9KjljF09OyXJAvl7hxccSAbXaph9b37lc6Xgenu5itfb_TwQ2b7BwHDM5kCcneh7TmX3WP2VmYNvFdtsqupnCL-2fkiU1x-Px-PyHfP364Xn_KL76df16vLnLDKznmaKW1FqVeQr1c1pUVbWN404imKWkLGjhtamZ0agUoBwnCNlaKumWCGqxMeULezLq74H9OGEfVu2iw6_SAfoqKJmEJsgKR0FcP0K2fwpCqu6OoELVgiXo9UxvdobpB3Y030XfT6PwQ1YpLBlzSOzk-gyb4GANatQuu12GvKKiDL2qrZl_UwRcFXCVfUtjL-yqmpsf2b9AfIxJwOgOYvu3WYVDROBwMti6gGVXr3f8yPBQwnRuc0d0P3GP817SKTIG6OszGYTSoLIFVQMvfufiy4w</recordid><startdate>20160801</startdate><enddate>20160801</enddate><creator>Flacco, Maria Elena, MD</creator><creator>Manzoli, Lamberto, MD, MPH</creator><creator>Boccia, Stefania, MD, PhD</creator><creator>Puggina, Anna, MD</creator><creator>Rosso, Annalisa, MD, MPH</creator><creator>Marzuillo, Carolina, MD</creator><creator>Scaioli, Giacomo, MD</creator><creator>Gualano, Maria Rosaria, MD</creator><creator>Ricciardi, Walter, MD, MPH</creator><creator>Villari, Paolo, MD, MPH</creator><creator>Ioannidis, John P.A., MD, PhD</creator><general>Elsevier Inc</general><general>Frontline Medical Communications Inc</general><general>Elsevier Limited</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>3V.</scope><scope>4U-</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>20160801</creationdate><title>Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey</title><author>Flacco, Maria Elena, MD ; Manzoli, Lamberto, MD, MPH ; Boccia, Stefania, MD, PhD ; Puggina, Anna, MD ; Rosso, Annalisa, MD, MPH ; Marzuillo, Carolina, MD ; Scaioli, Giacomo, MD ; Gualano, Maria Rosaria, MD ; Ricciardi, Walter, MD, MPH ; Villari, Paolo, MD, MPH ; Ioannidis, John P.A., MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c476t-ef6fffe6a8098897f5dbc4bb5bb31d0a041b92ca9420140605fbf659d251ce7c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Analysis</topic><topic>Clinical trials</topic><topic>Data Mining</topic><topic>Databases, Factual - statistics & numerical data</topic><topic>Drugs, Generic - pharmacokinetics</topic><topic>Generic drugs</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Prescription Drugs - classification</topic><topic>Prescription Drugs - pharmacokinetics</topic><topic>Publications - statistics & numerical data</topic><topic>Randomized Controlled Trials as Topic - statistics & numerical data</topic><topic>Registries</topic><topic>Surveys</topic><topic>Surveys and Questionnaires</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Flacco, Maria Elena, MD</creatorcontrib><creatorcontrib>Manzoli, Lamberto, MD, MPH</creatorcontrib><creatorcontrib>Boccia, Stefania, MD, PhD</creatorcontrib><creatorcontrib>Puggina, Anna, MD</creatorcontrib><creatorcontrib>Rosso, Annalisa, MD, MPH</creatorcontrib><creatorcontrib>Marzuillo, Carolina, MD</creatorcontrib><creatorcontrib>Scaioli, Giacomo, MD</creatorcontrib><creatorcontrib>Gualano, Maria Rosaria, MD</creatorcontrib><creatorcontrib>Ricciardi, Walter, MD, MPH</creatorcontrib><creatorcontrib>Villari, Paolo, MD, MPH</creatorcontrib><creatorcontrib>Ioannidis, John P.A., MD, PhD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>University Readers</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</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 China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Mayo Clinic proceedings</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Flacco, Maria Elena, MD</au><au>Manzoli, Lamberto, MD, MPH</au><au>Boccia, Stefania, MD, PhD</au><au>Puggina, Anna, MD</au><au>Rosso, Annalisa, MD, MPH</au><au>Marzuillo, Carolina, MD</au><au>Scaioli, Giacomo, MD</au><au>Gualano, Maria Rosaria, MD</au><au>Ricciardi, Walter, MD, MPH</au><au>Villari, Paolo, MD, MPH</au><au>Ioannidis, John P.A., MD, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey</atitle><jtitle>Mayo Clinic proceedings</jtitle><addtitle>Mayo Clin Proc</addtitle><date>2016-08-01</date><risdate>2016</risdate><volume>91</volume><issue>8</issue><spage>1021</spage><epage>1034</epage><pages>1021-1034</pages><issn>0025-6196</issn><eissn>1942-5546</eissn><coden>MACPAJ</coden><abstract>Abstract Objectives To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. Methods We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in ClinicalTrials.gov or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases. Data were compared across sponsorship categories (“inbred” if the compared drugs were owned by the same company or its partners/subsidiaries, “competitive” if the compared drugs were owned by competing companies, and “apparently nonprofit”), and time to publication was evaluated with Cox analysis. Results We found 207 registered protocols reporting on 186 completed trials. Among those trials, 37 had published their results and another 56 had posted results in registries, for a total of 93 trials with available results. Four years after trial completion, results were available for 64 of 138 trials (46.4%), with substantial differences by sponsor: 70.8% (34 of 48), 28.1% (18 of 64), and 46.2% (12 of 26) of the inbred, competitive, and nonprofit trials, respectively. In multivariate modeling, inbred trials had a 1.73-fold risk of having results available compared with competitive trials ( P =.04). Almost all trials reported favorable results, with the exception of 4 (4.3% of the 93 trials with results). Conclusion Despite the importance of generic drugs, relatively few registered randomized trials have compared the health effects of generic vs brand-name medicines, and there is an associated unsatisfactory publication rate and almost ubiquitous favorable results. The overall literature on the topic is at high risk of bias, possibly in favor of generic drugs. Higher nonprofit funding and stronger pressure to register trials and publish results are needed.</abstract><cop>England</cop><pub>Elsevier Inc</pub><pmid>27402583</pmid><doi>10.1016/j.mayocp.2016.04.032</doi><tpages>14</tpages></addata></record> |
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subjects | Analysis Clinical trials Data Mining Databases, Factual - statistics & numerical data Drugs, Generic - pharmacokinetics Generic drugs Humans Internal Medicine Prescription Drugs - classification Prescription Drugs - pharmacokinetics Publications - statistics & numerical data Randomized Controlled Trials as Topic - statistics & numerical data Registries Surveys Surveys and Questionnaires Therapeutic Equivalency |
title | Registered Randomized Trials Comparing Generic and Brand-Name Drugs: A Survey |
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