What Clinical Trial Speed Factors Can Sponsors Actually Control?
When promising drug candidates are identified for further investigation in clinical trials, sponsor companies are usually optimistic about outcomes.
But there are times, when after years of sunk effort and resources, clinical trials fail to bring a viable drug to market. Frequently, a drug fails for safety or efficacy reasons that are beyond a sponsor’s control. However, to some degree, sponsors can control:
- The speed with which they identify which drugs are viable vs not, and –
- Of those viable drugs, the speed with which they are developed
When drug development moves slower than expected, this isn’t just disappointing for sponsors, but also has costly implications for future trials, current resources, and competitive advantages.
High costs and lengthy study timelines are some of the major obstacles impeding clinical trial conduct in the United States:
- It costs between $314 million and $2.8 billion to bring a new drug to market
- It takes an average of 7.5 years from the start of clinical testing to marketing a new product
- Longer studies are needed to assess safety if the drug is to be taken long-term to manage chronic disease. This leads to longer timelines that increase costs and decrease revenue.
- Patient recruitment requires a substantial investment of time and money. Failure to recruit can also cause costly delays or trial cancellation – wasting resources.
Successfully completing clinical trials in less time (while maintaining high quality) is important for not just individual sponsors, but also for promoting innovation in the pharma space.
But improving efficiencies in the clinical trial process requires a comprehensive review of current standard practices.