Methodology in clinical research: why everyone should know it

Clinical Research Methodology is the discipline that allows to plan trials able to produce strong and reliable results in compliance with common ethical principles, scientific accuracy, and applicable regulations. Few years ago, Clinical Research Methodology was seen as a complex area managed and analysed only by biostatisticians and experts. Recently, it became more and more clear how important Clinical Research Methodology is not only for a selected number of experts, but for all the figures involved in the clinical trials management and conduction: everyone should know how to read and interpret properly a study protocol.

Methods and measurement tools knowledge, the competence to understand study results and the capacity to identify observed endpoints are essential to guarantee an overall and appropriate quality of the studies conducted.

Anyone who works in the world of clinical research can benefit from the study of the Clinical Research Methodology, the important thing is to be trained properly according to the role covered. For a medical advisor for instance, it could be fundamental to understand the necessary topics and information to manage the interaction with a physician, learning how to critically read abstracts and publications; for investigators and site staff it could be important to be focused on the preliminary evaluation and feasibility of non-profit studies, learning what does it mean to write a protocol; for the monitoring team could be interesting to learn the study populations, the study designs and the end-points definition; for members of Ethics Committee it could be important to know the different types of study and their implications.

Thanks to years of experience in clinical research and thanks to the direct management of specific trainings in the medical and biostatistic fields, the staff of PRINEOS can provide courses in Clinical Research Methodology at different levels, even starting from specific materials provided by the participants (example synopsis, abstract etc). The strong knowledge of the field, and the strong experience planning and conducting different type of studies in different therapeutic areas, allows our team of trainers to be focused on the specific participants needs, ensuring an approach both methodological and clinical.