Clinical trials with interim analyses: standardizing terminology to increase clarity
Abstract Interim analyses for group-sequential decision-making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to operationalize and interpret interim analyses exist for...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2025-07-01
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| Series: | Trials |
| Online Access: | https://doi.org/10.1186/s13063-025-08942-3 |
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| _version_ | 1849761329264459776 |
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| author | Elina Asikanius Benjamin Hofner Lisa V. Hampson Gernot Wassmer Christopher Jennison Tobias Mielke Cornelia Ursula Kunz Kaspar Rufibach |
| author_facet | Elina Asikanius Benjamin Hofner Lisa V. Hampson Gernot Wassmer Christopher Jennison Tobias Mielke Cornelia Ursula Kunz Kaspar Rufibach |
| author_sort | Elina Asikanius |
| collection | DOAJ |
| description | Abstract Interim analyses for group-sequential decision-making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to operationalize and interpret interim analyses exist for many stakeholders. In this paper, a team of statisticians from the pharmaceutical industry, academia, and regulatory agencies provide a multi-stakeholder perspective on the key concepts behind interim analyses, with the aim to introduce standard terminology to mitigate misunderstandings and facilitate clearer discussions. |
| format | Article |
| id | doaj-art-6fefc45dcf634b37b699321a82811bc9 |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-6fefc45dcf634b37b699321a82811bc92025-08-20T03:06:04ZengBMCTrials1745-62152025-07-0126111410.1186/s13063-025-08942-3Clinical trials with interim analyses: standardizing terminology to increase clarityElina Asikanius0Benjamin Hofner1Lisa V. Hampson2Gernot Wassmer3Christopher Jennison4Tobias Mielke5Cornelia Ursula Kunz6Kaspar Rufibach7Finnish Medicines AgencySection Data Science and Methods, Paul-Ehrlich-InstitutAdvanced Methodology & Data ScienceRPACT GbRDepartment of Mathematical Sciences, University of BathStatistics and Decision Sciences, Janssen-Cilag GmbHMethodology Group, Global Biostatistics and Data Sciences, Boehringer-IngelheimMethods, Collaboration, and Outreach Group, Product Development Data Sciences (MCO)Abstract Interim analyses for group-sequential decision-making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to operationalize and interpret interim analyses exist for many stakeholders. In this paper, a team of statisticians from the pharmaceutical industry, academia, and regulatory agencies provide a multi-stakeholder perspective on the key concepts behind interim analyses, with the aim to introduce standard terminology to mitigate misunderstandings and facilitate clearer discussions.https://doi.org/10.1186/s13063-025-08942-3 |
| spellingShingle | Elina Asikanius Benjamin Hofner Lisa V. Hampson Gernot Wassmer Christopher Jennison Tobias Mielke Cornelia Ursula Kunz Kaspar Rufibach Clinical trials with interim analyses: standardizing terminology to increase clarity Trials |
| title | Clinical trials with interim analyses: standardizing terminology to increase clarity |
| title_full | Clinical trials with interim analyses: standardizing terminology to increase clarity |
| title_fullStr | Clinical trials with interim analyses: standardizing terminology to increase clarity |
| title_full_unstemmed | Clinical trials with interim analyses: standardizing terminology to increase clarity |
| title_short | Clinical trials with interim analyses: standardizing terminology to increase clarity |
| title_sort | clinical trials with interim analyses standardizing terminology to increase clarity |
| url | https://doi.org/10.1186/s13063-025-08942-3 |
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