Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps?
Evidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however,...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2023-01-01
|
| Series: | Perspectives in Clinical Research |
| Subjects: | |
| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2023;volume=14;issue=3;spage=108;epage=113;aulast=Shau |
| _version_ | 1797738498608857088 |
|---|---|
| author | Wen-Yi Shau Sajita Setia Salil Shinde Handoko Santoso Daniel Furtner |
| author_facet | Wen-Yi Shau Sajita Setia Salil Shinde Handoko Santoso Daniel Furtner |
| author_sort | Wen-Yi Shau |
| collection | DOAJ |
| description | Evidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however, if the influence of external factors or confounders is not effectively managed, the cause-and-effect relationship and internal validity may be challenged, resulting in flawed results. The collection of quality real-world evidence (RWE) is crucial in Asia as there is often an underrepresentation of Asian populations in RCTs. In addition, few countries in Asia are catching up with the Western world in issuing practical foundational principles and guidance for conducting and adopting evidence for regulatory and reimbursement decisions. However, privacy and data protection laws are generally lagging behind technological developments in electronic medical records. While leveraging RWE in clinical and regulatory decision-making holds excellent potential, collective efforts across industry, governments, and research institutions are required for generating standardized practices and building capabilities for developing fit-for-purpose RWE in Asia. |
| first_indexed | 2024-03-12T13:44:39Z |
| format | Article |
| id | doaj.art-fe4ccffea5954793a1db60e85967365e |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-03-12T13:44:39Z |
| publishDate | 2023-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-fe4ccffea5954793a1db60e85967365e2023-08-23T09:47:08ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852023-01-0114310811310.4103/picr.picr_193_22Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps?Wen-Yi ShauSajita SetiaSalil ShindeHandoko SantosoDaniel FurtnerEvidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however, if the influence of external factors or confounders is not effectively managed, the cause-and-effect relationship and internal validity may be challenged, resulting in flawed results. The collection of quality real-world evidence (RWE) is crucial in Asia as there is often an underrepresentation of Asian populations in RCTs. In addition, few countries in Asia are catching up with the Western world in issuing practical foundational principles and guidance for conducting and adopting evidence for regulatory and reimbursement decisions. However, privacy and data protection laws are generally lagging behind technological developments in electronic medical records. While leveraging RWE in clinical and regulatory decision-making holds excellent potential, collective efforts across industry, governments, and research institutions are required for generating standardized practices and building capabilities for developing fit-for-purpose RWE in Asia.http://www.picronline.org/article.asp?issn=2229-3485;year=2023;volume=14;issue=3;spage=108;epage=113;aulast=Shauasiadecision-makinghealth technology assessmentrandomized controlled trialsreal-world datareal-world evidence |
| spellingShingle | Wen-Yi Shau Sajita Setia Salil Shinde Handoko Santoso Daniel Furtner Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? Perspectives in Clinical Research asia decision-making health technology assessment randomized controlled trials real-world data real-world evidence |
| title | Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? |
| title_full | Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? |
| title_fullStr | Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? |
| title_full_unstemmed | Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? |
| title_short | Generating fit-for-purpose real-world evidence in Asia: How far are we from closing the gaps? |
| title_sort | generating fit for purpose real world evidence in asia how far are we from closing the gaps |
| topic | asia decision-making health technology assessment randomized controlled trials real-world data real-world evidence |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2023;volume=14;issue=3;spage=108;epage=113;aulast=Shau |
| work_keys_str_mv | AT wenyishau generatingfitforpurposerealworldevidenceinasiahowfararewefromclosingthegaps AT sajitasetia generatingfitforpurposerealworldevidenceinasiahowfararewefromclosingthegaps AT salilshinde generatingfitforpurposerealworldevidenceinasiahowfararewefromclosingthegaps AT handokosantoso generatingfitforpurposerealworldevidenceinasiahowfararewefromclosingthegaps AT danielfurtner generatingfitforpurposerealworldevidenceinasiahowfararewefromclosingthegaps |