Central statistical monitoring of investigator-led clinical trials in oncology

Abstract

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.

Impact of the COVID-19 pandemic on clinical trials with drugs

“…The chapter "changes to monitoring and auditing" got more than four pages. Although there is no evidence that source data verification alters the results of clinical trials [5][6][7][8], many hours were spent by regulators to find consented solutions for it. The section 'risk assessment' received three quarters of a page.…”

Virtual oncology research-different models and lessons learned

“…This can be done in many ways: e.g., sharing scanned copies of trial documents via e-mail, sharing computer screen via a video-conferencing application or providing remote access to electronic medical records. A large part of trial costs is attributed to on-site monitoring, which for some large global clinical trials could be up to 60% of all trial costs [ 29 ]. However, there is no evidence to support this approach, and none of the randomised trials comparing intensive with less intensive monitoring have shown clinically relevant treatment outcomes [ 29 ].…”

“…A large part of trial costs is attributed to on-site monitoring, which for some large global clinical trials could be up to 60% of all trial costs [ 29 ]. However, there is no evidence to support this approach, and none of the randomised trials comparing intensive with less intensive monitoring have shown clinically relevant treatment outcomes [ 29 ]. We strongly advocate an approach of remote monitoring and risk-based monitoring even after the pandemic.…”

Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country

“…A clear distinction between pragmatic and explanatory approaches to clinical trials was proposed nearly fifty years ago, yet most trials conducted today adopt the explanatory approach, which is unnecessarily onerous [ 105 ]. Table 3 provides a comparison of trial characteristics under the explanatory and pragmatic approaches [ 19 ]. The COVID-19 pandemic provided empirical evidence that inefficiencies in clinical research can easily be overcome in pragmatic trials in times of emergency.…”