On-site clinical trial monitoring is estimated to account for up to 30 per cent of study costs and, according to some, is very inefficient. To look into the topic researchers from industry, regulators and academia sent a survey to people involved in the running of clinical trials.
“Results suggest that sponsors may be sub-optimally using their clinical trial and data management systems and consequently are missing an opportunity for significant increases in clinical trial efficiency”, said a research paper published in the journal Clinical Trials.
Limited use of centralised monitoring processes to “guide, target or supplement site visits” was highlighted as a particular inefficiency. This finding adds weight to a theory held by members of the Clinical Trials Transformation Initiative (CTTI), who authored the paper.
“It is a widely accepted hypothesis among CTTI members that onsite clinical trial monitoring is a source of significant inefficiency in the conduct of clinical trials, and that current monitoring activities do not always lead to increased quality in clinical trials”, said the researchers.
Visit motivations
The researchers also raised concerns about the reasons for onsite visits. Significant protocol deviations and suspected fraud were, understandably, the main prompts, but the researchers have doubts about some of the other common motivation factors, notably slow patient enrolment.
“Given the diversity of existing technologies, it seems quite possible that at least some verifications that are conducted today could be effectively – and more efficiently – conducted remotely”, said the researchers.
CTTI encourages “the exploration, analysis, and validation of innovative and efficient monitoring techniques” to supplement, and in some cases replace, current onsite visits.
Employees of Pfizer, the US Food and Drug Administration (FDA), Roche, Bristol-Myers Squibb, and Duke Translational Medicine Institute are among the authors of the paper. Icon, PPD, Sanofi, GlaxoSmithKline, Amgen, and AstraZeneca volunteered time and donated resources.