Clinical trials are required for drug approval. However, in the case of emerging treatments for lethal diseases (like gene-targeted agents, immunotherapies, CRISPR-based therapies and others), they can be unnecessarily slowed by inappropriate research designs. Once the trials are complete, complex bureaucratic systems and red tape add years to getting the treatments to people.
The cost is thousands of lives that are lost and unnecessary suffering – and drug prices that are driven up by the lengthy, costly process. A study published in Cancer Medicine looked at 27 different clinical trials. It showed that reducing drug approval time to five years could have saved more than 1,900,000 life-years if only 10% of all relevant patients were treated! Quick safe and rational reform is needed.