Dear Members:
One of my former basic science students, Dawid Chabowski, is in need of a consultant. It would be very advantageous for him to have someone in Europe and/or familiar with the regulatory requirements there. Please contact him if you are interested. His remarks follow.
Rodney Sparapani
Dear Biostatisicians:
We are in a process of reformulating a drug product in the cardiovascular area. This is a product in an area called generic plus (AKA value-added generics). This means that there is a reference product with clinical data available. In the process of bringing the product to the market, we need to run a clinical trial that evaluates the efficacy. Because of the existence of the reference listed drug, the clinical trial needs to compare the efficacy of the new vs. the old. Based on the available clinical data from the reference product, we need to decide what kind of trial is more advantageous for us to run in the context of regulatory requirements and boundaries. The two choices we are considering are either a non-inferiority trial or equivalence trial (unless there are other options we are not aware of). Thus, we are in need of advice/assistance from a biostatistician who has experience in several areas. The best would be someone who is well-versed in designing trials of comparative nature (as mentioned above) in the area of cardiovascular medicine, who can also take into consideration the requirements and regulations imposed by the European Medicines Agency (EMA). Please let me know if you need more information.
Dawid Chabowski
chabowskidawid@gmail.com ------------------------------
Rodney Sparapani
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