Importance of achieving the composite endpoints in diabetes
Well-conducted randomized controlled trials are instrumental in providing vital data on safety and efficacy of new molecules under consideration for approval. However acquiring such data involves huge cost and focused scientific endeavor. Selection and reporting of endpoints of a therapy is essentia...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2013-01-01
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| Series: | Indian Journal of Endocrinology and Metabolism |
| Subjects: | |
| Online Access: | http://www.ijem.in/article.asp?issn=2230-8210;year=2013;volume=17;issue=5;spage=835;epage=843;aulast=Unnikrishnan |
| _version_ | 1818021001161605120 |
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| author | Ambika Gopalakrishnan Unnikrishnan Arpandev Bhattacharyya Manash Pratim Baruah Binayak Sinha Mala Dharmalingam Paturi V Rao |
| author_facet | Ambika Gopalakrishnan Unnikrishnan Arpandev Bhattacharyya Manash Pratim Baruah Binayak Sinha Mala Dharmalingam Paturi V Rao |
| author_sort | Ambika Gopalakrishnan Unnikrishnan |
| collection | DOAJ |
| description | Well-conducted randomized controlled trials are instrumental in providing vital data on safety and efficacy of new molecules under consideration for approval. However acquiring such data involves huge cost and focused scientific endeavor. Selection and reporting of endpoints of a therapy is essential to assess the effect(s) of an intervention on overall disease control and guidelines have suggested the use of composite endpoint (CEP) in clinical trial design over individual endpoints to demonstrate the compound effect. Composite endpoints have been preferred for their ability to assess the net clinical benefit of an intervention, avoid misinterpretation associated with competing risks, avoid the challenge of using a single outcome to validate the study objectives and reduce the sample size requirements in trials on patients treated for diabetes. Concerns for misinterpretation or difficulty in interpretation of trial results involving CEPs arise when differences in the components with respect to either clinical importance or event rates, or magnitude of treatment effect exist and when there′s a possibility of biases due to competing risk. Suggestions for construction of composite endpoints and reporting the results of trials involving CEPs have been presented to improve the interpretations of overall effect of new interventions. |
| first_indexed | 2024-04-14T08:13:09Z |
| format | Article |
| id | doaj.art-b1f03eea2b9b4ef588afa94472b02b94 |
| institution | Directory Open Access Journal |
| issn | 2230-8210 2230-9500 |
| language | English |
| last_indexed | 2024-04-14T08:13:09Z |
| publishDate | 2013-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Indian Journal of Endocrinology and Metabolism |
| spelling | doaj.art-b1f03eea2b9b4ef588afa94472b02b942022-12-22T02:04:29ZengWolters Kluwer Medknow PublicationsIndian Journal of Endocrinology and Metabolism2230-82102230-95002013-01-0117583584310.4103/2230-8210.117225Importance of achieving the composite endpoints in diabetesAmbika Gopalakrishnan UnnikrishnanArpandev BhattacharyyaManash Pratim BaruahBinayak SinhaMala DharmalingamPaturi V RaoWell-conducted randomized controlled trials are instrumental in providing vital data on safety and efficacy of new molecules under consideration for approval. However acquiring such data involves huge cost and focused scientific endeavor. Selection and reporting of endpoints of a therapy is essential to assess the effect(s) of an intervention on overall disease control and guidelines have suggested the use of composite endpoint (CEP) in clinical trial design over individual endpoints to demonstrate the compound effect. Composite endpoints have been preferred for their ability to assess the net clinical benefit of an intervention, avoid misinterpretation associated with competing risks, avoid the challenge of using a single outcome to validate the study objectives and reduce the sample size requirements in trials on patients treated for diabetes. Concerns for misinterpretation or difficulty in interpretation of trial results involving CEPs arise when differences in the components with respect to either clinical importance or event rates, or magnitude of treatment effect exist and when there′s a possibility of biases due to competing risk. Suggestions for construction of composite endpoints and reporting the results of trials involving CEPs have been presented to improve the interpretations of overall effect of new interventions.http://www.ijem.in/article.asp?issn=2230-8210;year=2013;volume=17;issue=5;spage=835;epage=843;aulast=UnnikrishnanDiabetes mellitus type 2randomized controlled trials as topicresearch designtreatment outcome |
| spellingShingle | Ambika Gopalakrishnan Unnikrishnan Arpandev Bhattacharyya Manash Pratim Baruah Binayak Sinha Mala Dharmalingam Paturi V Rao Importance of achieving the composite endpoints in diabetes Indian Journal of Endocrinology and Metabolism Diabetes mellitus type 2 randomized controlled trials as topic research design treatment outcome |
| title | Importance of achieving the composite endpoints in diabetes |
| title_full | Importance of achieving the composite endpoints in diabetes |
| title_fullStr | Importance of achieving the composite endpoints in diabetes |
| title_full_unstemmed | Importance of achieving the composite endpoints in diabetes |
| title_short | Importance of achieving the composite endpoints in diabetes |
| title_sort | importance of achieving the composite endpoints in diabetes |
| topic | Diabetes mellitus type 2 randomized controlled trials as topic research design treatment outcome |
| url | http://www.ijem.in/article.asp?issn=2230-8210;year=2013;volume=17;issue=5;spage=835;epage=843;aulast=Unnikrishnan |
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