PHARMO is a scientific contract research organisation with more than 15 years of experience in studying the utilisation, safety and outcomes of drugs in daily practice. We have direct access to our own large, rich and high quality pharmaco-epidemiological Database Network including primary and secondary healthcare data which can be linked to specialized partnership registries, additional data collection and PRO data. Furtermore we coordinate or partner in pan-European multidatabase studies. We have a strong network of partner data sources across Europe with whom we collaborate on a regular basis.
Burden of illness studies are crucial for creating insight into your potential market and to guide your market access strategy. In a burden of illness study we can study the disease in general or focus on more detailed subpopulations with specific disease characteristics. The value of your product is not only limited to the disease of interest, but is also reflected in other outcomes like related complications or exacerbations of disease. In order to map all these outcomes we use our patient-level data to follow patients over time and determine the whole spectrum of disease-related outcomes.
Post-authorisation studies (PASS and PAES)
At the time of authorisation, there is evidence from clinical trials which demonstrates efficacy, but only for a specific indication and only within the original test population, and there is evidence of adverse reactions, but only the most common ones. In order to create a complete picture of the efficacy and safety of a drug in a real world setting, the authorities may request a post-authorisation efficacy study (PAES). These studies are requested or performed on a voluntary basis when additional information on the efficacy of your drug can only be determined after granting market authorisation or when previous efficacy evaluations should be revised. One of the main reasons for performing a PAES is to address uncertainties concerning subpopulations. Through our extensive Database Network we can easily identify relevant subgroups and stratify the efficacy results by subpopulation, which will give you insight into the effect of these characteristics on the efficacy of your therapy.
Besides additional efficacy data, there may also be a need for additional data on the safety of your treatment in a real life setting (PASS). Through the linkage of multiple databases, we can monitor whether patients using a certain drug have an increased risk of complications. Some of these complications may be diagnosed at the GP, but for the more severe complications you would need data from the hospital. Depending on your specific research question we will link the most relevant databases and will be able to monitor all safety issues in your patient population.
Important epidemiological aspects should be considered when performing a pharmocoepidemiological study using large real world datasets. Incorporating the statistical expertise from our researchers, we can handle matters such as time-related bias, confounding by indication and protopathic bias, which are inherent to our type of data. Our research team includes highly qualified professionals with many years of experience and will be happy to explore multiple analytical approaches appropriate to the research question at hand. Over the years we have accumulated much practical experience in different study designs dealing with bias and confounding, such as new-user designs, propensity scoring and case-only designs. The analyses we perform on the study data are always well-planned and are detailed in the statistical analysis plan we develop in cooperation with our client.
In order to successfully position and price a particular drug you will need a good understanding of the current therapeutic landscape and the added value of your product. Through a wide variety of studies we will be able to help you get a thorough insight in the current market. We are able to determine the size of your potential market through a burden of illness study or determine the epidemiology of disease. If you are more interested in your position compared to other similar drugs, we can help you with the relative effectiveness of your drug, determine the current treatment patterns or assess the uptake of your drug.
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