Clinically Important Effects in New Drug Development
Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Togo, Kanae [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
2011 |
|---|
| Anmerkung: |
© Drug Information Association, Inc 2011 |
|---|
| Übergeordnetes Werk: |
Enthalten in: Therapeutic innovation & regulatory science - [New York] : Springer Nature, 2013, 45(2011), 6 vom: Nov., Seite 805-810 |
|---|---|
| Übergeordnetes Werk: |
volume:45 ; year:2011 ; number:6 ; month:11 ; pages:805-810 |
| Links: |
|---|
| DOI / URN: |
10.1177/009286151104500517 |
|---|
| Katalog-ID: |
SPR038921103 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | SPR038921103 | ||
| 003 | DE-627 | ||
| 005 | 20230519124255.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 201007s2011 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1177/009286151104500517 |2 doi | |
| 035 | |a (DE-627)SPR038921103 | ||
| 035 | |a (SPR)009286151104500517-e | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Togo, Kanae |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinically Important Effects in New Drug Development |
| 264 | 1 | |c 2011 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a © Drug Information Association, Inc 2011 | ||
| 520 | |a Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. | ||
| 700 | 1 | |a Matsuoka, Nobushige |4 aut | |
| 700 | 1 | |a Hashigaki, Satoshi |4 aut | |
| 700 | 1 | |a Imai, Keiji |4 aut | |
| 700 | 1 | |a Moriya, Takashi |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Therapeutic innovation & regulatory science |d [New York] : Springer Nature, 2013 |g 45(2011), 6 vom: Nov., Seite 805-810 |w (DE-627)739896415 |w (DE-600)2708397-4 |x 2168-4804 |7 nnns |
| 773 | 1 | 8 | |g volume:45 |g year:2011 |g number:6 |g month:11 |g pages:805-810 |
| 856 | 4 | 0 | |u https://dx.doi.org/10.1177/009286151104500517 |z lizenzpflichtig |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a SYSFLAG_A | ||
| 912 | |a GBV_SPRINGER | ||
| 912 | |a SSG-OLC-PHA | ||
| 912 | |a GBV_ILN_120 | ||
| 912 | |a GBV_ILN_121 | ||
| 912 | |a GBV_ILN_150 | ||
| 951 | |a AR | ||
| 952 | |d 45 |j 2011 |e 6 |c 11 |h 805-810 | ||
| author_variant |
k t kt n m nm s h sh k i ki t m tm |
|---|---|
| matchkey_str |
article:21684804:2011----::lnclymotnefcsned |
| hierarchy_sort_str |
2011 |
| publishDate |
2011 |
| allfields |
10.1177/009286151104500517 doi (DE-627)SPR038921103 (SPR)009286151104500517-e DE-627 ger DE-627 rakwb eng Togo, Kanae verfasserin aut Clinically Important Effects in New Drug Development 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2011 Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. Matsuoka, Nobushige aut Hashigaki, Satoshi aut Imai, Keiji aut Moriya, Takashi aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 45(2011), 6 vom: Nov., Seite 805-810 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:45 year:2011 number:6 month:11 pages:805-810 https://dx.doi.org/10.1177/009286151104500517 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 45 2011 6 11 805-810 |
| spelling |
10.1177/009286151104500517 doi (DE-627)SPR038921103 (SPR)009286151104500517-e DE-627 ger DE-627 rakwb eng Togo, Kanae verfasserin aut Clinically Important Effects in New Drug Development 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2011 Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. Matsuoka, Nobushige aut Hashigaki, Satoshi aut Imai, Keiji aut Moriya, Takashi aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 45(2011), 6 vom: Nov., Seite 805-810 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:45 year:2011 number:6 month:11 pages:805-810 https://dx.doi.org/10.1177/009286151104500517 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 45 2011 6 11 805-810 |
| allfields_unstemmed |
10.1177/009286151104500517 doi (DE-627)SPR038921103 (SPR)009286151104500517-e DE-627 ger DE-627 rakwb eng Togo, Kanae verfasserin aut Clinically Important Effects in New Drug Development 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2011 Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. Matsuoka, Nobushige aut Hashigaki, Satoshi aut Imai, Keiji aut Moriya, Takashi aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 45(2011), 6 vom: Nov., Seite 805-810 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:45 year:2011 number:6 month:11 pages:805-810 https://dx.doi.org/10.1177/009286151104500517 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 45 2011 6 11 805-810 |
| allfieldsGer |
10.1177/009286151104500517 doi (DE-627)SPR038921103 (SPR)009286151104500517-e DE-627 ger DE-627 rakwb eng Togo, Kanae verfasserin aut Clinically Important Effects in New Drug Development 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2011 Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. Matsuoka, Nobushige aut Hashigaki, Satoshi aut Imai, Keiji aut Moriya, Takashi aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 45(2011), 6 vom: Nov., Seite 805-810 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:45 year:2011 number:6 month:11 pages:805-810 https://dx.doi.org/10.1177/009286151104500517 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 45 2011 6 11 805-810 |
| allfieldsSound |
10.1177/009286151104500517 doi (DE-627)SPR038921103 (SPR)009286151104500517-e DE-627 ger DE-627 rakwb eng Togo, Kanae verfasserin aut Clinically Important Effects in New Drug Development 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2011 Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. Matsuoka, Nobushige aut Hashigaki, Satoshi aut Imai, Keiji aut Moriya, Takashi aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 45(2011), 6 vom: Nov., Seite 805-810 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:45 year:2011 number:6 month:11 pages:805-810 https://dx.doi.org/10.1177/009286151104500517 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 45 2011 6 11 805-810 |
| language |
English |
| source |
Enthalten in Therapeutic innovation & regulatory science 45(2011), 6 vom: Nov., Seite 805-810 volume:45 year:2011 number:6 month:11 pages:805-810 |
| sourceStr |
Enthalten in Therapeutic innovation & regulatory science 45(2011), 6 vom: Nov., Seite 805-810 volume:45 year:2011 number:6 month:11 pages:805-810 |
| format_phy_str_mv |
Article |
| institution |
findex.gbv.de |
| isfreeaccess_bool |
false |
| container_title |
Therapeutic innovation & regulatory science |
| authorswithroles_txt_mv |
Togo, Kanae @@aut@@ Matsuoka, Nobushige @@aut@@ Hashigaki, Satoshi @@aut@@ Imai, Keiji @@aut@@ Moriya, Takashi @@aut@@ |
| publishDateDaySort_date |
2011-11-01T00:00:00Z |
| hierarchy_top_id |
739896415 |
| id |
SPR038921103 |
| language_de |
englisch |
| fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR038921103</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519124255.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2011 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1177/009286151104500517</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR038921103</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)009286151104500517-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Togo, Kanae</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Clinically Important Effects in New Drug Development</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2011</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Drug Information Association, Inc 2011</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials.</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Matsuoka, Nobushige</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Hashigaki, Satoshi</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Imai, Keiji</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Moriya, Takashi</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Therapeutic innovation & regulatory science</subfield><subfield code="d">[New York] : Springer Nature, 2013</subfield><subfield code="g">45(2011), 6 vom: Nov., Seite 805-810</subfield><subfield code="w">(DE-627)739896415</subfield><subfield code="w">(DE-600)2708397-4</subfield><subfield code="x">2168-4804</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:45</subfield><subfield code="g">year:2011</subfield><subfield code="g">number:6</subfield><subfield code="g">month:11</subfield><subfield code="g">pages:805-810</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1177/009286151104500517</subfield><subfield code="z">lizenzpflichtig</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_120</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_121</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_150</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">45</subfield><subfield code="j">2011</subfield><subfield code="e">6</subfield><subfield code="c">11</subfield><subfield code="h">805-810</subfield></datafield></record></collection>
|
| author |
Togo, Kanae |
| spellingShingle |
Togo, Kanae Clinically Important Effects in New Drug Development |
| authorStr |
Togo, Kanae |
| ppnlink_with_tag_str_mv |
@@773@@(DE-627)739896415 |
| format |
electronic Article |
| delete_txt_mv |
keep |
| author_role |
aut aut aut aut aut |
| collection |
springer |
| remote_str |
true |
| illustrated |
Not Illustrated |
| issn |
2168-4804 |
| topic_title |
Clinically Important Effects in New Drug Development |
| format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
| format_main_str_mv |
Text Zeitschrift/Artikel |
| carriertype_str_mv |
cr |
| hierarchy_parent_title |
Therapeutic innovation & regulatory science |
| hierarchy_parent_id |
739896415 |
| hierarchy_top_title |
Therapeutic innovation & regulatory science |
| isfreeaccess_txt |
false |
| familylinks_str_mv |
(DE-627)739896415 (DE-600)2708397-4 |
| title |
Clinically Important Effects in New Drug Development |
| ctrlnum |
(DE-627)SPR038921103 (SPR)009286151104500517-e |
| title_full |
Clinically Important Effects in New Drug Development |
| author_sort |
Togo, Kanae |
| journal |
Therapeutic innovation & regulatory science |
| journalStr |
Therapeutic innovation & regulatory science |
| lang_code |
eng |
| isOA_bool |
false |
| recordtype |
marc |
| publishDateSort |
2011 |
| contenttype_str_mv |
txt |
| container_start_page |
805 |
| author_browse |
Togo, Kanae Matsuoka, Nobushige Hashigaki, Satoshi Imai, Keiji Moriya, Takashi |
| container_volume |
45 |
| format_se |
Elektronische Aufsätze |
| author-letter |
Togo, Kanae |
| doi_str_mv |
10.1177/009286151104500517 |
| title_sort |
clinically important effects in new drug development |
| title_auth |
Clinically Important Effects in New Drug Development |
| abstract |
Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. © Drug Information Association, Inc 2011 |
| abstractGer |
Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. © Drug Information Association, Inc 2011 |
| abstract_unstemmed |
Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials. © Drug Information Association, Inc 2011 |
| collection_details |
GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 |
| container_issue |
6 |
| title_short |
Clinically Important Effects in New Drug Development |
| url |
https://dx.doi.org/10.1177/009286151104500517 |
| remote_bool |
true |
| author2 |
Matsuoka, Nobushige Hashigaki, Satoshi Imai, Keiji Moriya, Takashi |
| author2Str |
Matsuoka, Nobushige Hashigaki, Satoshi Imai, Keiji Moriya, Takashi |
| ppnlink |
739896415 |
| mediatype_str_mv |
c |
| isOA_txt |
false |
| hochschulschrift_bool |
false |
| doi_str |
10.1177/009286151104500517 |
| up_date |
2024-07-03T20:44:04.848Z |
| _version_ |
1803592080923033600 |
| fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR038921103</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519124255.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2011 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1177/009286151104500517</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR038921103</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)009286151104500517-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Togo, Kanae</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Clinically Important Effects in New Drug Development</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2011</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Drug Information Association, Inc 2011</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract In new drug development, demonstrating a clinically important effect of the new drug is a key element of efficacy evaluations instead of simply showing a statistical significance. However, approaches to demonstrate clinically important effects are unclear and not well recognized among many investigators and sponsors. The minimal clinically important change from baseline (MCIC) and minimal clinically important difference between groups (MCID) are used to assess the clinically important effect. We state the roles of MCIC and MCID in each phase of new drug development and common approaches to establishing MCIC and MCID. Furthermore, we provide some common approaches on how to practically compare the clinical trial results with the MCIC and MCID and interpret the clinical importance from applications in new drug development. We also suggest incorporating the clinical importance at the planning phase of trials.</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Matsuoka, Nobushige</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Hashigaki, Satoshi</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Imai, Keiji</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Moriya, Takashi</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Therapeutic innovation & regulatory science</subfield><subfield code="d">[New York] : Springer Nature, 2013</subfield><subfield code="g">45(2011), 6 vom: Nov., Seite 805-810</subfield><subfield code="w">(DE-627)739896415</subfield><subfield code="w">(DE-600)2708397-4</subfield><subfield code="x">2168-4804</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:45</subfield><subfield code="g">year:2011</subfield><subfield code="g">number:6</subfield><subfield code="g">month:11</subfield><subfield code="g">pages:805-810</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1177/009286151104500517</subfield><subfield code="z">lizenzpflichtig</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_120</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_121</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_150</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">45</subfield><subfield code="j">2011</subfield><subfield code="e">6</subfield><subfield code="c">11</subfield><subfield code="h">805-810</subfield></datafield></record></collection>
|
| score |
7.398568 |