Central statistical monitoring of investigator-led clinical trials in oncology

Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, wh...

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Bibliographic Details
Published in:International journal of clinical oncology 2020-07, Vol.25 (7), p.1207-1214
Main Authors: Buyse, Marc, Trotta, Laura, Saad, Everardo D., Sakamoto, Junichi
Format: Article
Language:English
Subjects:
Cancer Research
Clinical trials
Clinical Trials as Topic - economics
Clinical Trials as Topic - organization & administration
Clinical Trials as Topic - statistics & numerical data
Humans
Invited Review
Invited Review Article
Medical Oncology - statistics & numerical data
Medical statistics
Medicine
Medicine & Public Health
Oncology
Quality Control
Quality management
Research Personnel
Statistical analysis
Statistics
Surgical Oncology
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Summary:Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, which are in part due to extensive trial monitoring processes that focus on unimportant details. Risk-based quality management focuses, instead, on “things that really matter”. We discuss the role of central statistical monitoring as part of risk-based quality management. We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality.
ISSN:1341-9625
1437-7772
DOI:10.1007/s10147-020-01726-6