Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials

Aim: Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness. Method: Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. Result: In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. Conclusion: We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data management. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.