Primary Endpoint Solutions was founded because, incredibly, the majority of Phase III clinical trials fail. History is littered with studies in which replication of results was not accomplished, where site variation was profound, and where expected efficacy signals were not obtained.
How can that happen when drugs have been vetted in two prior study phases, as well as in pre-clinical testing?
Perhaps the test agent simply doesn’t work. Or are there significant shortcomings in study design and, particularly, in the selection and capture of primary and secondary endpoints?
It is not surprising, given the wide variation in clinical practice standards, assessors’ experiences and training, and weak descriptions of specific endpoint criteria, that sponsors often find themselves dealing with endpoint data that are uninterpretable and inconsistent across sites and investigators. This can be especially true when endpoints are based on responses that are dependent on clinician-based assessments. PES was founded to focus solely on these problems and provide its client partners with the highest endpoint data quality (EdQ™).