SOPHIE BERNARD
PRINEOS srl, Milano, Italy

INTRODUCTION
Clinical trials are challenging by definition. Even though any clinical research entails a certain degree of uncertainty regarding its potential success, several clinical trials challenges come with opportunities for improvement and are major drivers of innovation.

PRINEOS srl proposes this column with the aim of spreading greater awareness about challenges and opportunities for improvement in clinical trials, addressing several crucial topics in this context.
Our journey starts with the topic “Privacy Compliance and Clinical trials” as privacy compliance has been (and may still be) quite challenging for all stakeholders involved in clinical research, considering also the lack of a general legal framework on this subject.

In the upcoming articles we will cover key aspects of clinical research methodology being critical for the success of a clinical trial, namely the sample size calculation and the endpoints definition. As highlighted by a research from the Tufts Center for the Study of Drug Development, nearly 60% of clinical study protocol require at least one substantial amendment wit ...