Drug Development [Internet]

Excerpt

The cost of bringing a medical product to the U.S. market has been increasing and clinical trials constitute a large portion of these costs. In drug development, the clinical phase lasts an average of around 95 months compared to 31 months for the non-clinical phase and accounts for 69 percent of overall R&D costs (DiMasi, et al., 2016). Clinical trials contribute significantly to the rising cost trend as they have become more expensive, complex, and lengthier over time. Thus, there is ongoing interest in reducing the overall cost of medical product development by improving the efficiency of clinical trials conducted in support of regulatory submission for marketing approval. This study quantified the potential impacts of the select strategies on the cost, duration, and phase transition probability associated with drug development, using data from a variety of sources. The average out-of-pocket cost per drug was estimated at $172.7 million, which is significantly lower than published findings that used data reported by primarily large pharmaceutical companies. After accounting for cost of failures and capital, the cost per drug was estimated at $879.3 million, and is also generally lower than most published estimates. The analysis also showed that clinical trials comprised the largest portion of overall drug development costs at $117.4 million which accounted for around 68 percent of out-of-pocket R&D expenditures. The study found that the strategy with the largest expected impact on overall development costs across all therapeutic areas was Improvements in FDA Review Process Efficiency and Interactions (−27.1 percent), followed by Adaptive Design (−22.8 percent), and implementation of a Simplified Clinical Trial Protocols and Reduced Amendments (−22.2 percent). Those strategies with the lowest expected development cost savings across all therapeutic areas included Use of Patient Registries (−9.9 percent), use of Biomarkers as Surrogate Endpoints (−13.3 percent), Electronic Health Records (−13.6 percent), and use of Standardized Contracts (−14.8 percent).