Post-marketing research: to get the complete picture and to understand everything about your drug
Several factors may influence patient response to treatment before and after authorisation, i.e. in a trial setting versus in daily clinical practice. At the time of authorisation efficacy and safety are demonstrated in clinical trials, but only for a specific indication and only within a specific population. Therefore, the current regulatory model focuses on a life cycle approach, rather than a single pre-marketing approach. The life cycle approach includes an assessment of risks and benefits under real life conditions, following controlled clinical trials, to get the complete picture. The PHARMO Institute performs a variety of studies to support post-marketing research, including effectiveness, healthcare utilisation and post-authorisation safety studies. Post-marketing research is needed as the standardised conditions in clinical trials are very different from the real world of prescribing and use. In contrast to clinical trials the real world environment shows a great variability in drug response, related to factors such as genetics, age, co-morbidities, co-medication, prescribing and patient adherence and utilisation. Discrepancies in patient selection or treatment conditions of patients in daily clinical practice may alter both the effectiveness and risks as found in clinical trials.
Our Database Network meets your need for cost-effective and efficient post-marketing studies.
If you need more information on how we perform our post-marketing research studies, please contact us.