Interim Clinical Trial/Study Report

An Interim Clinical Trial/Study Report is a Report that includes intermediate and preliminary results based on a interim analysis performed during the course of a clinical trial.

• Example(s):
  • Multicenter Automatic Defibrillator Implantation Trial (MADIT II) report;
  • COVID-19 vaccine: Xia et al. (2020)'s study report;
  • SARS-CoV-2 variant mRNA vaccine boosters: Choi et al, 2021's study report;
  • REASSURE: Dizdarevic et al. (2019)'s study] report;
  • …
• Counter-Example(s):
  • Clinical Trial Audit Report.
• See: Clinical Trial, Clinical Dataset, Data Analysis Task, Clinical Research Data Management System.

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References

2022a

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Interim_analysis Retrieved:2022-3-20.
  • In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. Clinical trials are unusual in that enrollment of subjects is a continual process staggered in time. If a treatment can be proven to be clearly beneficial or harmful compared to the concurrent control, or to be obviously futile, based on a pre-defined analysis of an incomplete data set while the study is on-going, the investigators may stop the study early.

2022b

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-3-20.
  • Interim Clinical Trial/Study Report
    • A report of intermediate results and their evaluation based on analyses performed during the course of a trial. (ICH E6)

2021

• (Choi et al., 2021) ⇒ Angela Choi, Matthew Koch, Kai Wu, Laurence Chu, LingZhi Ma, Anna Hill, Naveen Nunna, Wenmei Huang, Judy Oestreicher, Tonya Colpitts, Hamilton Bennett, Holly Legault, Yamuna Paila, Biliana Nestorova, Baoyu Ding, David Montefiori, Rolando Pajon, Jacqueline M. Miller, Brett Leav, Andrea Carfi, Roderick McPhee, and Darin K. Edwards (2021). "Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis". In: Nature Medicine, 27(11), 2025-2031.

2020

• (Xia et al., 2020) ⇒ Shengli Xia, Kai Duan, Yuntao Zhang, Dongyang Zhao, Huajun Zhang, Zhiqiang Xie, Xinguo Li, Cheng Peng, Yanbo Zhang, Wei Zhang, Yunkai Yang, Wei Chen, Xiaoxiao Gao, Wangyang You, Xuewei Wang, Zejun Wang, Zhengli Shi, Yanxia Wang, Xuqin Yang, Lianghao Zhang, Lili Huang, Qian Wang, Jia Lu, Yongli Yang, Jing Guo, Wei Zhou, Xin Wan, Cong Wu, Wenhui Wang, Shihe Huang, Jianhui Du, Ziyan Meng, An Pan, Zhiming Yuan, Shuo Shen, Wanshen Guo, and Xiaoming Yang (2020).

2019

• (Dizdarevic et al., 2019) ⇒ Sabina Dizdarevic, Peter Meidahl Petersen, Markus Essler, Annibale Versari, Jean-Cyril Bourre, Christian la Fougere, Riccardo Valdagni, Giovanni Paganelli, Samer Ezziddin, Jan Kalinovsky, Inga Bayh, and Yong Du (2019). "Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice". In: European journal of nuclear medicine and molecular imaging, 46(5), 1102-1110.

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