Current Edition

Minimisation of Systematic Deviations: An Example of Risk Management in the Conduct of Clinical Trials

All sponsors try to optimise their resources when conducting clinical trials, and sometimes the desire to reduce study budgets leads to the selection of less experienced or even ill-suited partners, consultants, vendors, and CROs. But using suboptimal partners may cause failure of the trial or the collection of uninformative data, which in turn lead to repetition of one or more clinical trials, or even termination of drug development. Anna Zhukova, Eric Batson, Iryna Teslenko, Maxim Belotserkovsky and Maxim Kosov of PSI CRO AG discuss ways to significantly reduce protocol deviations; based on their experience, an indicator of ineffective risk management in the conduct of a clinical trial is the occurrence of systematic deviations from the clinical trial protocol.