Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Risk Based Monitoring – impact and benefits for small and medium-sized enterprises

Milva Mateblowski (Abschlußjahr: 2013)

Summary
Language: English
The main focus (80%) of current monitoring techniques lies on 100% on-site source data verification (SDV). This is a very resource-intensive programme and is responsible for 30% expenses of the total budget of a study but it only counts for less than 3% data changes. The use of modern monitoring techniques should bring progress in safety and quality of clinical trials and reduce cost and time needed for drug development by using a so called risk-based approach. The key element of a risk-based monitoring (RBM) is to identify the sources of risk that influences the objectives of the clinical trial most. Sources of high risk will be monitored more frequently than other parts of study. Probably the most effective way of implementation of RBM is a mixed approach from declining monitoring and the three tiered approach. A company needs specific tools to support the conduct of a risk-based monitoring approach from a place remote to the trial site. Another pre-requisite is a well-defined and planed risk management plan.
This thesis analyses the conditions under which an implementation of RBM for SMEs is appropriate and what advantages or disadvantages the size of a company has on the implementation. Cost savings for very early phase studies (phase I/ II) are not to be expected. Since the investment into new study systems required for risk-based monitoring is very high, potential savings in monitoring visits are not significant. A questionnaire used in this thesis supported the opinion that there is no difference, in regard of implementation, impact and benefits of risk-based monitoring, between small and medium sized enterprises and Big Pharma. Due to the lower capacity of SMEs in comparison to large companies, in terms of number of employees and budget, SMEs perform more studies with a low number of data points (independent of the phase of the study). Hence, the implementation of RBM itself might not be rewarding for SMEs. RBM is mainly not a tool in order to reduce costs, but to make monitoring more efficient. It helps to focus attention on trial centres where abnormal data pattern suggests focusing monitoring activities where they are most needed.
Pages: 40 Annexes: 1, pages: 1