The Copenhagen Phase IV Unit (Phase4Cph)
By applying state of the art research methodology, Phase4Cph creates insight in evidence-based use of medications: drug utilization, safety, effectiveness and health economics.
We have a profound insight in the Danish health registries, allowing us unique opportunities to investigate drug-exposure outcome relations. We have experience with studies on marketed drugs, both in broad populations and in specific subgroups. Furthermore, we have access to prospective cohorts, with a wide range of clinical measurements.
We engage in
- Public-private partnerships
- Health authority-initiated studies
- Post-authorization safety (PASS) and efficacy studies (PAES)
- Comparative effectiveness research (CER)
- Real world evidence on drug effectiveness, safety and utilization
- Potential new indications for established drugs
Phase4Cph is a collaboration between Center for Clinical Research and Prevention and the Department of Clinical Pharmacology at Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
General about Phase IV Studies
Phase IV Studies are conducted to identify and evaluate the long-term effects of new drugs and treatments over a lengthy period for a greater number of patients. Phase IV is an important phase of drug development, and in recent years phase IV have got more attention. No matter how many patients are studied pre-marketing (Phase I, II, III) in a controlled environment, the true safety profile of a drug is characterized only by continuing safety surveillance through a spontaneous adverse event monitoring system and a post-marketing surveillance/non-interventional study. Also, Phase IV studies may be used to estimate the intended effect of drugs. Similarly to safety issues, effect seen in pre-marketing studies, conducted in a controlled environment, may not be directly translated to the more diverse, heterogenic and more complex patient population seen in clinical practice.
Phase IV studies collect information about side-effects and safety, long-term risks and benefits, and/or how well the medicine works when used widely. Data collection can be based prospective studies or based on data collected for other purpose for example registries.