Up, Up, and Away: Clinical Trials Go International

What is this about?

This is a short interview with a research who describes some of the ethical issues that arise from running international clinical trials. The researcher gives the example of the fictional US based company Rx who wants to run a trial in Russia for a certain medication. One reason for such a company to 'outsource' a clinical trial is lower costs in other countries. Questions asked in the case include 'what is the quality of the informed consent?' and 'can you promise participants to receive a certain drug for the study period, but not afterwards?'

Why is this important?

As described in the case: "Clinical trials are one of the most expensive steps in pharmaceutical and device development for biomedical companies. Each phase of the trial can cost up to twenty million dollars to run."^[1] However, clinical trials are an important step to ensure the efficiency, safety and dosage of a drug.