Multi-regional clinical trials and global drug development
Drug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innova...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2016-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=2;spage=62;epage=67;aulast=Shenoy |
| _version_ | 1811324102392152064 |
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| author | Premnath Shenoy |
| author_facet | Premnath Shenoy |
| author_sort | Premnath Shenoy |
| collection | DOAJ |
| description | Drug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH) has initiated the process for having a harmonized guidance document on MRCT. This document is likely to be issued in early 2017. |
| first_indexed | 2024-04-13T14:08:18Z |
| format | Article |
| id | doaj.art-03c3e728561c470a995f53188cbc3b8d |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-04-13T14:08:18Z |
| publishDate | 2016-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-03c3e728561c470a995f53188cbc3b8d2022-12-22T02:43:51ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852016-01-0172626710.4103/2229-3485.179430Multi-regional clinical trials and global drug developmentPremnath ShenoyDrug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH) has initiated the process for having a harmonized guidance document on MRCT. This document is likely to be issued in early 2017.http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=2;spage=62;epage=67;aulast=ShenoyClinical trialsinternational conference on harmonizationmulti-regionalUnited States of America Food and Drug Administration |
| spellingShingle | Premnath Shenoy Multi-regional clinical trials and global drug development Perspectives in Clinical Research Clinical trials international conference on harmonization multi-regional United States of America Food and Drug Administration |
| title | Multi-regional clinical trials and global drug development |
| title_full | Multi-regional clinical trials and global drug development |
| title_fullStr | Multi-regional clinical trials and global drug development |
| title_full_unstemmed | Multi-regional clinical trials and global drug development |
| title_short | Multi-regional clinical trials and global drug development |
| title_sort | multi regional clinical trials and global drug development |
| topic | Clinical trials international conference on harmonization multi-regional United States of America Food and Drug Administration |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=2;spage=62;epage=67;aulast=Shenoy |
| work_keys_str_mv | AT premnathshenoy multiregionalclinicaltrialsandglobaldrugdevelopment |