Background

U.S. regulations¹ require that sponsors be held responsible for oversight of clinical investigations to ensure protection of human subjects and the quality and integrity of resulting data.  Although general guidelines for Good Clinical Practice (GCP) are described in the International Conference on Harmonization (ICH) guideline E6, there is latitude given regarding the extent and nature of monitoring.

Unfortunately, little empirical evidence exists to determine which practices best achieve the goals of trial monitoring stated in ICH E6 across a range of clinical trial settings.  This lack of information is concerning, especially given the contention by some in the clinical research field that cumbersome monitoring practices contribute to more work and higher costs for clinical studies.  One study suggests that on-site monitoring, commonly used by industry sponsors, can represent approximately 25 to 30% of trial costs.²

Because of growing concern about the effectiveness and efficiency of monitoring practices, the CTTI made monitoring the focus of its first project.

 

Goal

Identify best practices and provide sensible criteria to help sponsors select the most appropriate monitoring methods for a clinical trial, thereby ensuring reliable and informative trial results and human subjects' protection.

 

Objectives

• Describe the range of current monitoring practices and examine factors that drive their adoption (Workstream 1)
• Define key quality objectives for monitoring clinical trials (Workstream 2)
• Examine ways to build quality into trials to enable more focused and efficient monitoring (Workstream 3)

 

Methods and Results

Workstream 1

Workstream 2

Workstream 3

CTTI Recommendations

 

Team Organization

 

Funding and Other Support

Financial support was provided by the CTTI general project fund, grant U19 FD003800 from the U.S. Food and Drug Administration (FDA), and a contribution from Roche. Volunteer time and donated resources were provided by Amgen Inc., AstraZeneca, Biosense Webster Inc., Bristol-Myers Squibb, Duke Clinical Research Institute, FDA, GlaxoSmithKline, ICON Clinical Research, Medtronic Inc., Pfizer Inc., PMG Research Inc., Pharmaceutical Product Development Inc., Roche, sanofi-aventis U.S. LLC, Target Health Inc., Training Extension, University of Minnesota, and University of Oxford.

 

Contact Information

Please send your questions or comments to  

 

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¹21 CFR 312 Subpart D; 21 CFR 812 Subpart C.

² Eisenstein EL, Lemons PW 2nd, Tardiff BE, Schulman KA, Jolly MK, Califf RM.  Reducing the costs of phase III cardiovascular clinical trials.  Am Heart J.  2005;149;482-8.