Download File - JOHN J. HADDAD, Ph.D.

Personalized Cancer Vaccines 81
early and informed decision-making through prospectively defined ‘go’ or ‘no go’
decision points, use of biologic end points, adjusted clinical end points, early use
of randomized trials, and adaptive design components, where applicable.” However,
there remain challenges with being able to effectively apply some of these
concepts in the better-prognosis patient setting. The ability to glean reliable
information regarding potential efficacy at time points early in a clinical trial
remains a challenge and a barrier to accelerated decision making.
Continued innovation and dialogue in the regulatory process for cancer
vaccine development will be critical for the sustained investment of time, effort,
and funds—without which progress in this novel and important area may never
be achieved.
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