High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey
International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Questionnaire surveys were...
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| Veröffentlicht in: | PloS one 2014-01, Vol.9 (1), p.e84998 |
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| creator | Kurihara, Chieko Kusuoka, Hideo Ono, Shunsuke Kakee, Naoko Saito, Kazuyuki Takehara, Kenji Tsujide, Kiyokazu Nabeoka, Yuzo Sakuhiro, Takuya Aoki, Hiroshi Morishita, Noriko Suzuki, Chieko Kachi, Shigeo Kondo, Emiko Komori, Yukiko Isobe, Tetsu Kageyama, Shigeru Watanabe, Hiroshi |
| description | International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported.
Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.
With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.
Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data. |
| doi_str_mv | 10.1371/journal.pone.0084998 |
| format | Article |
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Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.
With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.
Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0084998</identifier><identifier>PMID: 24416332</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Childrens health ; Clinical medicine ; Clinical trials ; Clinical Trials as Topic ; Compensation ; Compensation and Redress ; Drug Industry - economics ; Drug Industry - ethics ; Drug Industry - statistics & numerical data ; Drugs, Investigational - adverse effects ; Ethical standards ; Ethics ; Health care ; Healthy Volunteers - legislation & jurisprudence ; Hospitals ; Human subjects ; Humans ; Incidence ; Injuries ; Institutions ; Insurance Claim Review - economics ; Insurance Claim Review - ethics ; Insurance Claim Review - statistics & numerical data ; Insurance policies ; International standardization ; Japan ; Liability insurance ; Medical device industry ; Medical equipment ; Medical research ; Medical technology ; Medicine ; Norms ; Patients ; Personal injuries ; Pharmaceutical industry ; Pharmaceuticals ; Polls & surveys ; Questionnaires ; Science Policy ; Social and Behavioral Sciences ; Statistics ; Surveys ; Surveys and Questionnaires ; Wounds and Injuries - chemically induced ; Wounds and Injuries - economics</subject><ispartof>PloS one, 2014-01, Vol.9 (1), p.e84998</ispartof><rights>COPYRIGHT 2014 Public Library of Science</rights><rights>2014 Kurihara et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Kurihara et al 2014 Kurihara et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c802t-a2472c93b561ccaf6801baacc0304cebf0d8d2347a5fcdb2743f305b0a4fdf763</citedby><cites>FETCH-LOGICAL-c802t-a2472c93b561ccaf6801baacc0304cebf0d8d2347a5fcdb2743f305b0a4fdf763</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3885663/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3885663/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79472,79473</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24416332$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Diemert, David Joseph</contributor><creatorcontrib>Kurihara, Chieko</creatorcontrib><creatorcontrib>Kusuoka, Hideo</creatorcontrib><creatorcontrib>Ono, Shunsuke</creatorcontrib><creatorcontrib>Kakee, Naoko</creatorcontrib><creatorcontrib>Saito, Kazuyuki</creatorcontrib><creatorcontrib>Takehara, Kenji</creatorcontrib><creatorcontrib>Tsujide, Kiyokazu</creatorcontrib><creatorcontrib>Nabeoka, Yuzo</creatorcontrib><creatorcontrib>Sakuhiro, Takuya</creatorcontrib><creatorcontrib>Aoki, Hiroshi</creatorcontrib><creatorcontrib>Morishita, Noriko</creatorcontrib><creatorcontrib>Suzuki, Chieko</creatorcontrib><creatorcontrib>Kachi, Shigeo</creatorcontrib><creatorcontrib>Kondo, Emiko</creatorcontrib><creatorcontrib>Komori, Yukiko</creatorcontrib><creatorcontrib>Isobe, Tetsu</creatorcontrib><creatorcontrib>Kageyama, Shigeru</creatorcontrib><creatorcontrib>Watanabe, Hiroshi</creatorcontrib><title>High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported.
Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.
With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.
Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.</description><subject>Childrens health</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Compensation</subject><subject>Compensation and Redress</subject><subject>Drug Industry - economics</subject><subject>Drug Industry - ethics</subject><subject>Drug Industry - statistics & numerical data</subject><subject>Drugs, Investigational - adverse effects</subject><subject>Ethical standards</subject><subject>Ethics</subject><subject>Health care</subject><subject>Healthy Volunteers - legislation & jurisprudence</subject><subject>Hospitals</subject><subject>Human subjects</subject><subject>Humans</subject><subject>Incidence</subject><subject>Injuries</subject><subject>Institutions</subject><subject>Insurance Claim Review - economics</subject><subject>Insurance Claim Review - ethics</subject><subject>Insurance Claim Review - statistics & numerical data</subject><subject>Insurance policies</subject><subject>International standardization</subject><subject>Japan</subject><subject>Liability insurance</subject><subject>Medical device industry</subject><subject>Medical equipment</subject><subject>Medical research</subject><subject>Medical technology</subject><subject>Medicine</subject><subject>Norms</subject><subject>Patients</subject><subject>Personal injuries</subject><subject>Pharmaceutical industry</subject><subject>Pharmaceuticals</subject><subject>Polls & surveys</subject><subject>Questionnaires</subject><subject>Science Policy</subject><subject>Social and Behavioral 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Industry - ethics</topic><topic>Drug Industry - statistics & numerical data</topic><topic>Drugs, Investigational - adverse effects</topic><topic>Ethical standards</topic><topic>Ethics</topic><topic>Health care</topic><topic>Healthy Volunteers - legislation & jurisprudence</topic><topic>Hospitals</topic><topic>Human subjects</topic><topic>Humans</topic><topic>Incidence</topic><topic>Injuries</topic><topic>Institutions</topic><topic>Insurance Claim Review - economics</topic><topic>Insurance Claim Review - ethics</topic><topic>Insurance Claim Review - statistics & numerical data</topic><topic>Insurance policies</topic><topic>International standardization</topic><topic>Japan</topic><topic>Liability insurance</topic><topic>Medical device industry</topic><topic>Medical equipment</topic><topic>Medical research</topic><topic>Medical technology</topic><topic>Medicine</topic><topic>Norms</topic><topic>Patients</topic><topic>Personal injuries</topic><topic>Pharmaceutical 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kurihara, Chieko</au><au>Kusuoka, Hideo</au><au>Ono, Shunsuke</au><au>Kakee, Naoko</au><au>Saito, Kazuyuki</au><au>Takehara, Kenji</au><au>Tsujide, Kiyokazu</au><au>Nabeoka, Yuzo</au><au>Sakuhiro, Takuya</au><au>Aoki, Hiroshi</au><au>Morishita, Noriko</au><au>Suzuki, Chieko</au><au>Kachi, Shigeo</au><au>Kondo, Emiko</au><au>Komori, Yukiko</au><au>Isobe, Tetsu</au><au>Kageyama, Shigeru</au><au>Watanabe, Hiroshi</au><au>Diemert, David Joseph</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2014-01-08</date><risdate>2014</risdate><volume>9</volume><issue>1</issue><spage>e84998</spage><pages>e84998-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported.
Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.
With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.
Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country's compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>24416332</pmid><doi>10.1371/journal.pone.0084998</doi><tpages>e84998</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2014-01, Vol.9 (1), p.e84998 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1476180284 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Childrens health Clinical medicine Clinical trials Clinical Trials as Topic Compensation Compensation and Redress Drug Industry - economics Drug Industry - ethics Drug Industry - statistics & numerical data Drugs, Investigational - adverse effects Ethical standards Ethics Health care Healthy Volunteers - legislation & jurisprudence Hospitals Human subjects Humans Incidence Injuries Institutions Insurance Claim Review - economics Insurance Claim Review - ethics Insurance Claim Review - statistics & numerical data Insurance policies International standardization Japan Liability insurance Medical device industry Medical equipment Medical research Medical technology Medicine Norms Patients Personal injuries Pharmaceutical industry Pharmaceuticals Polls & surveys Questionnaires Science Policy Social and Behavioral Sciences Statistics Surveys Surveys and Questionnaires Wounds and Injuries - chemically induced Wounds and Injuries - economics |
| title | High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey |
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