5 Questions That Reveal Whether A Drug Programme Is Built To Succeed

A Q&A with the CEO of the Centre for Human Drug Research on why the strongest clinical development programmes are organised around questions, not simply phases.

Moving a drug from Phase I to Phase II may look like progress, but phase completion alone does not show whether a programme is resolving the scientific uncertainties that determine success. A stronger strategy begins by asking what the development team most urgently needs to learn.

Five questions provide a practical stress test: Does the drug reach its intended site of action? Does it produce the expected functional effect? Does that effect translate into meaningful clinical benefit? Is there a workable therapeutic window? And how will patient variability influence outcomes?

Organising development around these questions can sharpen study design, connect exposure with desirable and undesirable effects, and make negative results more informative. It can also reveal when an early experiment may prevent greater expense later by resolving a programme-threatening uncertainty before additional capital is committed.