According to current data average time and cost of a new drug to reach the market is 12 years and costs £1.15 billion but what is not included in this statistics is the fact that many new potential drugs never make it to the market due to various reasons.
European Center for Pharmaceutical Medicine has summarised the following reasons for late stage drug testing failure:
- Scientific – the animal models are not properly related to human disease; poor understanding of the disease or just the drug is ineffective;
- Clinical Study Design – some of the reasons in failure in phase 3 studies is that patients are selected on a different criteria than phase 2 studies, the studies are not able to confirm the results from phase 2 or the measured outcomes were insensitive.
- Inappropriate Study Design – it may not show efficacy or the patient population is too small to perform adequate evaluation.
- Dose Selection – may not be adequate for phase 3 studies if the results from phase 2.
- Data Collection and Analysis – false positive signals from phase 2 or overoptimistic assumptions.
- Operational Execution – related to data integrity issues or GCP violations.
Adaptive clinical trials design is one of the novel approaches which aims to reduce drug development timelines and costs.
While there is no simple solution to these issues one of the possible approaches is to invest more time in creating optimal study design and make sure the correct endpoints are selected. While timelines are important setting up the study right from the beginning is critical for its success.
Published on 5 Feb 2019
Author: Olga Peycheva, Director at Solutions OP Ltd. Olga has been working in clinical research since 2005 and has extensive experience in Eastern and Western Europe