Global issues in drug development for Alzheimer’s disease
Abstract The number of clinical trials for Alzheimer’s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural...
Gespeichert in:
| Veröffentlicht in: | Alzheimer's & dementia 2011-03, Vol.7 (2), p.197-207 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 207 |
|---|---|
| container_issue | 2 |
| container_start_page | 197 |
| container_title | Alzheimer's & dementia |
| container_volume | 7 |
| creator | Doody, Rachelle S Cole, Patricia E Miller, David S Siemers, Eric Black, Ronald Feldman, Howard Schindler, Rachel Graham, Stephen Heath, Theresa Khachaturian, Ara S Evans, Rebecca Carrillo, Maria C |
| description | Abstract The number of clinical trials for Alzheimer’s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer’s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer’s disease. |
| doi_str_mv | 10.1016/j.jalz.2011.01.001 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_887493603</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S155252601100032X</els_id><sourcerecordid>887493603</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4471-f5e91c9a6a0db6a05df907f2972bb986f21ea89cf4ad861c5aa2db602d9ee2993</originalsourceid><addsrcrecordid>eNqNksFu1DAQhiMEoqXwAhxQbpx2mXHixBYIaVVBoVqJAyAhLpZjT8DBSbb2pmh74jV4PZ4ERyk9cKBI1tiyvvlnNP9k2WOENQJWz7p1p_3VmgHiGtIBvJMdI-dsxVkt7968KzjKHsTYAZQgkN_PjhiWWHJeHWfPz_zYaJ-7GCeKuRtyG6YvuaVL8uOup2Gft2PIN_7qK7mewq8fP2NuXSQd6WF2r9U-0qPr-yT7-PrVh9M3q-27s7enm-3KlGWNq5aTRCN1pcE2KXDbSqhbJmvWNFJULUPSQpq21FZUaLjWLIHArCRiUhYn2dNFdxfGi9TlXvUuGvJeDzROUQlRl7KooLidrFgtOOfidpLXAsuqhESyhTRhjDFQq3bB9TocFIKafVCdmn1Qsw8K0gFMSU-u5aemJ3uT8mfwCdgswHfn6fAfkmqz_Xx-nsL8B7gUebFoUBr-paOgonE0GLIukNkrO7p_9_jyr3Tj3eCM9t_oQLEbpzAkWxWqyBSo9_M2zcuUygMU7FPxG07QwZw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>857814640</pqid></control><display><type>article</type><title>Global issues in drug development for Alzheimer’s disease</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Applied Social Sciences Index & Abstracts (ASSIA)</source><creator>Doody, Rachelle S ; Cole, Patricia E ; Miller, David S ; Siemers, Eric ; Black, Ronald ; Feldman, Howard ; Schindler, Rachel ; Graham, Stephen ; Heath, Theresa ; Khachaturian, Ara S ; Evans, Rebecca ; Carrillo, Maria C</creator><creatorcontrib>Doody, Rachelle S ; Cole, Patricia E ; Miller, David S ; Siemers, Eric ; Black, Ronald ; Feldman, Howard ; Schindler, Rachel ; Graham, Stephen ; Heath, Theresa ; Khachaturian, Ara S ; Evans, Rebecca ; Carrillo, Maria C</creatorcontrib><description>Abstract The number of clinical trials for Alzheimer’s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer’s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer’s disease.</description><identifier>ISSN: 1552-5260</identifier><identifier>EISSN: 1552-5279</identifier><identifier>DOI: 10.1016/j.jalz.2011.01.001</identifier><identifier>PMID: 21414556</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Alzheimer Disease - drug therapy ; Alzheimer's disease ; Clinical trials ; Clinical Trials as Topic ; Congresses as Topic ; Critical incidents ; Drug Discovery ; Global perspective ; Humans ; National identity ; Neurology ; Regional variations</subject><ispartof>Alzheimer's & dementia, 2011-03, Vol.7 (2), p.197-207</ispartof><rights>The Alzheimer's Association</rights><rights>2011 The Alzheimer's Association</rights><rights>Copyright © 2011 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4471-f5e91c9a6a0db6a05df907f2972bb986f21ea89cf4ad861c5aa2db602d9ee2993</citedby><cites>FETCH-LOGICAL-c4471-f5e91c9a6a0db6a05df907f2972bb986f21ea89cf4ad861c5aa2db602d9ee2993</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1016%2Fj.jalz.2011.01.001$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1016%2Fj.jalz.2011.01.001$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,30979,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21414556$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Doody, Rachelle S</creatorcontrib><creatorcontrib>Cole, Patricia E</creatorcontrib><creatorcontrib>Miller, David S</creatorcontrib><creatorcontrib>Siemers, Eric</creatorcontrib><creatorcontrib>Black, Ronald</creatorcontrib><creatorcontrib>Feldman, Howard</creatorcontrib><creatorcontrib>Schindler, Rachel</creatorcontrib><creatorcontrib>Graham, Stephen</creatorcontrib><creatorcontrib>Heath, Theresa</creatorcontrib><creatorcontrib>Khachaturian, Ara S</creatorcontrib><creatorcontrib>Evans, Rebecca</creatorcontrib><creatorcontrib>Carrillo, Maria C</creatorcontrib><title>Global issues in drug development for Alzheimer’s disease</title><title>Alzheimer's & dementia</title><addtitle>Alzheimers Dement</addtitle><description>Abstract The number of clinical trials for Alzheimer’s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer’s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer’s disease.</description><subject>Alzheimer Disease - drug therapy</subject><subject>Alzheimer's disease</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Congresses as Topic</subject><subject>Critical incidents</subject><subject>Drug Discovery</subject><subject>Global perspective</subject><subject>Humans</subject><subject>National identity</subject><subject>Neurology</subject><subject>Regional variations</subject><issn>1552-5260</issn><issn>1552-5279</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><recordid>eNqNksFu1DAQhiMEoqXwAhxQbpx2mXHixBYIaVVBoVqJAyAhLpZjT8DBSbb2pmh74jV4PZ4ERyk9cKBI1tiyvvlnNP9k2WOENQJWz7p1p_3VmgHiGtIBvJMdI-dsxVkt7968KzjKHsTYAZQgkN_PjhiWWHJeHWfPz_zYaJ-7GCeKuRtyG6YvuaVL8uOup2Gft2PIN_7qK7mewq8fP2NuXSQd6WF2r9U-0qPr-yT7-PrVh9M3q-27s7enm-3KlGWNq5aTRCN1pcE2KXDbSqhbJmvWNFJULUPSQpq21FZUaLjWLIHArCRiUhYn2dNFdxfGi9TlXvUuGvJeDzROUQlRl7KooLidrFgtOOfidpLXAsuqhESyhTRhjDFQq3bB9TocFIKafVCdmn1Qsw8K0gFMSU-u5aemJ3uT8mfwCdgswHfn6fAfkmqz_Xx-nsL8B7gUebFoUBr-paOgonE0GLIukNkrO7p_9_jyr3Tj3eCM9t_oQLEbpzAkWxWqyBSo9_M2zcuUygMU7FPxG07QwZw</recordid><startdate>201103</startdate><enddate>201103</enddate><creator>Doody, Rachelle S</creator><creator>Cole, Patricia E</creator><creator>Miller, David S</creator><creator>Siemers, Eric</creator><creator>Black, Ronald</creator><creator>Feldman, Howard</creator><creator>Schindler, Rachel</creator><creator>Graham, Stephen</creator><creator>Heath, Theresa</creator><creator>Khachaturian, Ara S</creator><creator>Evans, Rebecca</creator><creator>Carrillo, Maria C</creator><general>Elsevier Inc</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>7X8</scope><scope>7TK</scope><scope>7QJ</scope></search><sort><creationdate>201103</creationdate><title>Global issues in drug development for Alzheimer’s disease</title><author>Doody, Rachelle S ; Cole, Patricia E ; Miller, David S ; Siemers, Eric ; Black, Ronald ; Feldman, Howard ; Schindler, Rachel ; Graham, Stephen ; Heath, Theresa ; Khachaturian, Ara S ; Evans, Rebecca ; Carrillo, Maria C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4471-f5e91c9a6a0db6a05df907f2972bb986f21ea89cf4ad861c5aa2db602d9ee2993</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Alzheimer Disease - drug therapy</topic><topic>Alzheimer's disease</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Congresses as Topic</topic><topic>Critical incidents</topic><topic>Drug Discovery</topic><topic>Global perspective</topic><topic>Humans</topic><topic>National identity</topic><topic>Neurology</topic><topic>Regional variations</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Doody, Rachelle S</creatorcontrib><creatorcontrib>Cole, Patricia E</creatorcontrib><creatorcontrib>Miller, David S</creatorcontrib><creatorcontrib>Siemers, Eric</creatorcontrib><creatorcontrib>Black, Ronald</creatorcontrib><creatorcontrib>Feldman, Howard</creatorcontrib><creatorcontrib>Schindler, Rachel</creatorcontrib><creatorcontrib>Graham, Stephen</creatorcontrib><creatorcontrib>Heath, Theresa</creatorcontrib><creatorcontrib>Khachaturian, Ara S</creatorcontrib><creatorcontrib>Evans, Rebecca</creatorcontrib><creatorcontrib>Carrillo, Maria C</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Neurosciences Abstracts</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><jtitle>Alzheimer's & dementia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Doody, Rachelle S</au><au>Cole, Patricia E</au><au>Miller, David S</au><au>Siemers, Eric</au><au>Black, Ronald</au><au>Feldman, Howard</au><au>Schindler, Rachel</au><au>Graham, Stephen</au><au>Heath, Theresa</au><au>Khachaturian, Ara S</au><au>Evans, Rebecca</au><au>Carrillo, Maria C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Global issues in drug development for Alzheimer’s disease</atitle><jtitle>Alzheimer's & dementia</jtitle><addtitle>Alzheimers Dement</addtitle><date>2011-03</date><risdate>2011</risdate><volume>7</volume><issue>2</issue><spage>197</spage><epage>207</epage><pages>197-207</pages><issn>1552-5260</issn><eissn>1552-5279</eissn><abstract>Abstract The number of clinical trials for Alzheimer’s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer’s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer’s disease.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>21414556</pmid><doi>10.1016/j.jalz.2011.01.001</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1552-5260 |
| ispartof | Alzheimer's & dementia, 2011-03, Vol.7 (2), p.197-207 |
| issn | 1552-5260 1552-5279 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_887493603 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Applied Social Sciences Index & Abstracts (ASSIA) |
| subjects | Alzheimer Disease - drug therapy Alzheimer's disease Clinical trials Clinical Trials as Topic Congresses as Topic Critical incidents Drug Discovery Global perspective Humans National identity Neurology Regional variations |
| title | Global issues in drug development for Alzheimer’s disease |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-22T06%3A08%3A57IST&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=Global%20issues%20in%20drug%20development%20for%20Alzheimer%E2%80%99s%20disease&rft.jtitle=Alzheimer's%20&%20dementia&rft.au=Doody,%20Rachelle%20S&rft.date=2011-03&rft.volume=7&rft.issue=2&rft.spage=197&rft.epage=207&rft.pages=197-207&rft.issn=1552-5260&rft.eissn=1552-5279&rft_id=info:doi/10.1016/j.jalz.2011.01.001&rft_dat=%3Cproquest_cross%3E887493603%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=857814640&rft_id=info:pmid/21414556&rft_els_id=S155252601100032X&rfr_iscdi=true |