Question

The process of submitting a new drug for FDA approval has 5 "steps," and takes years. Discuss one limitation of each of the following “steps” in the FDA’s drug approval process:

1. Preclinical research
2. Phase 1 Trial
3. Phase 2 Trial
4. Phase 3 Trial
5. "Phase 4" post-market surveillance.

(Don't define the phase. Instead, explain what limitations there are to the research associated with each step.)

Answer 1

Pre clinical phase involves use of in vitro or in vivo technology which is expensive as the trial may not give desired results

Phase 1 trial involves testing in apparently healthy individuals. The major limitation is lack of clinical data on diseased individuals that how much they can cope with this

Phsse 2 are more subject to various types of bias such as selection bias (since patients are likely to be highly selected), surveillance bias, and publication bias.

Phase 3 it is difficult to interpret or generalize the results because the studied population is very different from the population treated in normal life

Phase 4 the major limitation is lack of information regarding clinical outcome data and lack of information regarding indication of use of product