The potential for a controlled human infection platform in Singapore
For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for furt...
Gespeichert in:
| Veröffentlicht in: | Singapore medical journal 2014-09, Vol.55 (9), p.456-461 |
|---|---|
| Hauptverfasser: | , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 461 |
|---|---|
| container_issue | 9 |
| container_start_page | 456 |
| container_title | Singapore medical journal |
| container_volume | 55 |
| creator | Balasingam, Shobana Horby, Peter Wilder-Smith, Annelies |
| description | For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies. |
| doi_str_mv | 10.11622/smedj.2014114 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4293939</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1586097828</sourcerecordid><originalsourceid>FETCH-LOGICAL-c390t-83def7c3c782fd5b70850f30ac17b7f76804c10166418481d0f68a1f0571957e3</originalsourceid><addsrcrecordid>eNpVkD1PwzAQhj2AaCmsjMgjS4s_4thZkBDfUiUGymy5jt26cuJgJ0j8e0xbKtANJ929d_fcC8AFRjOMS0KuU2PqzYwgXGBcHIExQpRPWcnZCJymtEGIcCTECRgRRjitiBiD-8XawC70pu2d8tCGCBXUoe1j8N7UcD00qoWutUb3LrSw86rPoiaX4JtrV6oL0ZyBY6t8Muf7PAHvjw-Lu-fp_PXp5e52PtW0Qv1U0NpYrqnmgtiaLTMMQ5YipTFfcstLgQqNES7LAotC4BrZUihsEeO4YtzQCbjZ7e2GZX5VZ-iovOyia1T8kkE5-b_TurVchU9ZkIr-xARc7RfE8DGY1MvGJW28V60JQ5KYiRJVGU9k6Wwn1TGkFI09nMFIbu2WW7vl3u48cPkX7iD_9Zp-AxyVfpo</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1586097828</pqid></control><display><type>article</type><title>The potential for a controlled human infection platform in Singapore</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Balasingam, Shobana ; Horby, Peter ; Wilder-Smith, Annelies</creator><creatorcontrib>Balasingam, Shobana ; Horby, Peter ; Wilder-Smith, Annelies</creatorcontrib><description>For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies.</description><identifier>ISSN: 0037-5675</identifier><identifier>DOI: 10.11622/smedj.2014114</identifier><identifier>PMID: 25273928</identifier><language>eng</language><publisher>Singapore: Singapore Medical Association</publisher><subject>Asia ; Clinical Trials as Topic - economics ; Clinical Trials as Topic - standards ; Communicable Disease Control ; Communicable Diseases - epidemiology ; Cost-Benefit Analysis ; Ethics, Medical ; Health Policy ; Humans ; Infectious Disease Medicine - legislation & jurisprudence ; Infectious Disease Medicine - standards ; Quarantine ; Research Design - standards ; Review ; Singapore ; United Kingdom</subject><ispartof>Singapore medical journal, 2014-09, Vol.55 (9), p.456-461</ispartof><rights>Copyright: © Singapore Medical Association 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-83def7c3c782fd5b70850f30ac17b7f76804c10166418481d0f68a1f0571957e3</citedby><cites>FETCH-LOGICAL-c390t-83def7c3c782fd5b70850f30ac17b7f76804c10166418481d0f68a1f0571957e3</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/PMC4293939/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4293939/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,315,728,781,785,886,27929,27930,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25273928$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Balasingam, Shobana</creatorcontrib><creatorcontrib>Horby, Peter</creatorcontrib><creatorcontrib>Wilder-Smith, Annelies</creatorcontrib><title>The potential for a controlled human infection platform in Singapore</title><title>Singapore medical journal</title><addtitle>Singapore Med J</addtitle><description>For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies.</description><subject>Asia</subject><subject>Clinical Trials as Topic - economics</subject><subject>Clinical Trials as Topic - standards</subject><subject>Communicable Disease Control</subject><subject>Communicable Diseases - epidemiology</subject><subject>Cost-Benefit Analysis</subject><subject>Ethics, Medical</subject><subject>Health Policy</subject><subject>Humans</subject><subject>Infectious Disease Medicine - legislation & jurisprudence</subject><subject>Infectious Disease Medicine - standards</subject><subject>Quarantine</subject><subject>Research Design - standards</subject><subject>Review</subject><subject>Singapore</subject><subject>United Kingdom</subject><issn>0037-5675</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkD1PwzAQhj2AaCmsjMgjS4s_4thZkBDfUiUGymy5jt26cuJgJ0j8e0xbKtANJ929d_fcC8AFRjOMS0KuU2PqzYwgXGBcHIExQpRPWcnZCJymtEGIcCTECRgRRjitiBiD-8XawC70pu2d8tCGCBXUoe1j8N7UcD00qoWutUb3LrSw86rPoiaX4JtrV6oL0ZyBY6t8Muf7PAHvjw-Lu-fp_PXp5e52PtW0Qv1U0NpYrqnmgtiaLTMMQ5YipTFfcstLgQqNES7LAotC4BrZUihsEeO4YtzQCbjZ7e2GZX5VZ-iovOyia1T8kkE5-b_TurVchU9ZkIr-xARc7RfE8DGY1MvGJW28V60JQ5KYiRJVGU9k6Wwn1TGkFI09nMFIbu2WW7vl3u48cPkX7iD_9Zp-AxyVfpo</recordid><startdate>201409</startdate><enddate>201409</enddate><creator>Balasingam, Shobana</creator><creator>Horby, Peter</creator><creator>Wilder-Smith, Annelies</creator><general>Singapore Medical Association</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>5PM</scope></search><sort><creationdate>201409</creationdate><title>The potential for a controlled human infection platform in Singapore</title><author>Balasingam, Shobana ; Horby, Peter ; Wilder-Smith, Annelies</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-83def7c3c782fd5b70850f30ac17b7f76804c10166418481d0f68a1f0571957e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Asia</topic><topic>Clinical Trials as Topic - economics</topic><topic>Clinical Trials as Topic - standards</topic><topic>Communicable Disease Control</topic><topic>Communicable Diseases - epidemiology</topic><topic>Cost-Benefit Analysis</topic><topic>Ethics, Medical</topic><topic>Health Policy</topic><topic>Humans</topic><topic>Infectious Disease Medicine - legislation & jurisprudence</topic><topic>Infectious Disease Medicine - standards</topic><topic>Quarantine</topic><topic>Research Design - standards</topic><topic>Review</topic><topic>Singapore</topic><topic>United Kingdom</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Balasingam, Shobana</creatorcontrib><creatorcontrib>Horby, Peter</creatorcontrib><creatorcontrib>Wilder-Smith, Annelies</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>PubMed Central (Full Participant titles)</collection><jtitle>Singapore medical journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Balasingam, Shobana</au><au>Horby, Peter</au><au>Wilder-Smith, Annelies</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The potential for a controlled human infection platform in Singapore</atitle><jtitle>Singapore medical journal</jtitle><addtitle>Singapore Med J</addtitle><date>2014-09</date><risdate>2014</risdate><volume>55</volume><issue>9</issue><spage>456</spage><epage>461</epage><pages>456-461</pages><issn>0037-5675</issn><abstract>For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies.</abstract><cop>Singapore</cop><pub>Singapore Medical Association</pub><pmid>25273928</pmid><doi>10.11622/smedj.2014114</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0037-5675 |
| ispartof | Singapore medical journal, 2014-09, Vol.55 (9), p.456-461 |
| issn | 0037-5675 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4293939 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Asia Clinical Trials as Topic - economics Clinical Trials as Topic - standards Communicable Disease Control Communicable Diseases - epidemiology Cost-Benefit Analysis Ethics, Medical Health Policy Humans Infectious Disease Medicine - legislation & jurisprudence Infectious Disease Medicine - standards Quarantine Research Design - standards Review Singapore United Kingdom |
| title | The potential for a controlled human infection platform in Singapore |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-15T00%3A56%3A21IST&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=The%20potential%20for%20a%20controlled%20human%20infection%20platform%20in%20Singapore&rft.jtitle=Singapore%20medical%20journal&rft.au=Balasingam,%20Shobana&rft.date=2014-09&rft.volume=55&rft.issue=9&rft.spage=456&rft.epage=461&rft.pages=456-461&rft.issn=0037-5675&rft_id=info:doi/10.11622/smedj.2014114&rft_dat=%3Cproquest_pubme%3E1586097828%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1586097828&rft_id=info:pmid/25273928&rfr_iscdi=true |