Weekly Tip on Clinical Trials Tip #1

Many of you are now planning your first ever clinical trial. Congrats! you are probably seeking a KOL as a lead investigator, or a high profile medical center. but will this truly be beneficial to you? Consider this –

– In remote or rural areas there are often close patient-physician relationships, where they know and trust each other better than in central areas.

– Lower profile medical centers, even in central locations, are less crowded with other studies, and their staff may be more motivated and dedicated.

– In less developed countries, the standard of care may be more conservative, and both patients and caregivers are seeking affordable, new solutions.

– Planning a study with a low and limited budget? Aim for the best composition of recruitment potential and cost effectiveness, not for the highest profile site.

– Planning your First In Human study? you only need a small number of subjects, but you also need a dedicated but experienced team, an excellent communication with the site and a good recruitment potential.

Most of you think I am stating the obvious. But am I? How much time did you actually put into the selection of site?

So here is the bottom line: Truly take the time to define your needs and expectations – timelines, approval process, costs, recruitment expectations and indication. then build a matrix, ranking your criteria in a descending order of importance. Then identify several potential sites, preferably in different countries, and rank their suitability according to your criteria. The combined ranking will give you the best options. Spoiler: The results might surprise you!

In the picture – me, in a very remote place in Central-Eastern Europe, after completing a First In Human study in just under two weeks 🙂

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