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. 2025 Mar;59(2):211-214.
doi: 10.1007/s43441-024-00728-0. Epub 2025 Jan 8.

Interim Clinical Trial Data: Who Can See What, and When?

Susan S Ellenberg  1 , Yimei Li  2
Affiliations

Interim Clinical Trial Data: Who Can See What, and When?

Susan S Ellenberg et al. Ther Innov Regul Sci. 2025 Mar.

Abstract

It has long been a basic principle of randomized clinical trials addressing serious outcomes and/or major public health issues that interim data should be inaccessible to investigators and to industry sponsors, with interim data reviewed on a regular basis by an independent data monitoring committee (DMC). Challenges to this principle may arise when sponsors and/or regulators perceive a need to review interim data while the trial remains ongoing-for example, when a trial is being considered for accelerated approval. In this paper we propose approaches that could minimize the extent of interim data that is made available to others while the trial continues.

Keywords: Accelerated Approval; Clinical Trials; Confidentiality; Data Monitoring Committee; Endpoints.

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Conflict of interest statement

Declarations. Competing Interests: The authors declare no competing interests.

References

    1. Fleming TR, Sharples K, McCall J, Moore A, Rodgers A, Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and capability. Clin Trials. 2008;5:157–67. - DOI - PubMed - PMC
    1. FDA Guidance for clinical trials sponsors. Establishment and Operation of Clinical Trials Data Monitoring Committees 2006 Accessed 11/14/2024. https://www.fda.gov/media/75398/download
    1. https:// www.forbes.com/sites/larryhusten/2015/03/03/orexigen-released-interim-da...
    1. Food and Drug Administration. Clinical Trial Considerations to Support Accelerated Approval of Oncology Drugs: Guidance for Industry. 2023. https://www.fda.gov/media/166431/download . Accessed 9/4/2024.
    1. Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials. 2015;12:5–11. - DOI - PubMed

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