Study planning: the real challenge

A clinical trial is research, planned research to identify the most appropriate medical, surgical intervention/treatment to nurse pathologies that affect patients with specific clinical conditions. The concept of "planned research" immediately shows how fundamental is, before starting a clinical trial, to dedicate time and resources to identify an appropriate study design and rationale, answering the following questions with extreme rigor:

  • Which is the primary objective of the research? Is it scientifically relevant? Does it address unresolved problems, does it contribute to the scientific knowledge adding anything new?
  • Are there secondary endpoints?
  • Is the number of patients to be enrolled sufficient?
  • Is the study design has been appropriately identified?
  • Applicable laws have been respected and considered?
  • Patients’ protection and data confidentiality have been guaranteed?
  • Is there a written protocol clearly reporting procedures and data through which achieve goals defined?

Clinical trials must be planned very carefully, their goal is to define whether the drug studied is safe and works, a very challenging goal that makes us aware on how important is to reach the famous statistical significance expected. However, it is important to always keep in mind that a statistical significance does not necessarily means a clinical significance. To obtain reliable data both from a clinical and statistical point of view, it is necessary to involve competent figures in the study planning phase, ensuring a constant and fruitful cooperation between clinicians and methodologists to identify the right objectives and the appropriate methods.

PRINEOS’ team, made up of clinicians, methodologists, privacy, and regulatory experts, is available to all Clients who want to deal with the world of clinical research by conceiving, planning, and designing a new trial. Our staff experience has consolidated across more than twenty-five years of activity in the pharmaceutical and in the CRO field by participating in the  design and conduct of studies in all phases and therapeutic areas.