While the push for sponsors to go global with clinical studies is old news, choosing the right sites and the right countries to host a particular study remains one of the industry’s most impenetrable challenges. Over the past few weeks, I have participated in several conferences on clinical operations improvements and remain baffled by the limited progress study teams have made in this area over the past five to 10 years. Ultimately, site selection matters because investigator sites are the only place where study volunteers can participate in clinical research. Enrollment is the end game – further drug development, regulatory submissions and marketing are contingent on having these data.
That said, it makes sense to start from the final step – patient enrollment. Begin by analyzing the protocol from a patient recruitment perspective – its particular enrollment challenges, and compare them to a set of patient-related factors in each country in order to determine which countries are the best fit for the study. Effective site selection is dependent on identifying the countries that have the fewest recruitment barriers and are likely to enroll the most patient in the least amount of time.