Question

Why do so many drug candidates fail to continue in drug development at the IND stage relative to failures during the phase 3 and NDA/BLA preparation stage

Answer 1

Ans) Nearly 14 percent of all drugs in clinical trials eventually win approval from the FDA.

- Approval rates ranged from a high of 33.4 percent in vaccines for infectious diseases to 3.4 percent for investigational cancer treatments. Previous estimates placed overall success rates, from Phase I through to FDA approval, between 9 and 11 percent.

- In addition, the study found that trials that used biomarkers to stratify patients tended to be more successful than those that did not, pointing to the growing role of companion diagnostics in improving clinical trial success rates and future designs.

- Broad implications for investors, regulators, policymakers and clinicians in calculating the probability of the success of investments in drug development programs.

“Without accurate and timely estimates, resources may be misallocated and financial returns may be misjudged, which leads to higher development costs, higher-priced drugs, and lost opportunities for investors and, more importantly, patients.