Three ways to run a more efficient drug trial
Find ways to improve efficiency and reduce costs with technology, data and advanced analytics.
Nearly half the expenses companies have for a new drug are for trial amendments, delays and failures1. A single protocol amendment can add almost $500,000 in unplanned expenses and extend a protocol by 61 days2, so focusing on drug trial efficiency can go a long way towards cutting costs and reducing the impact of trial failures and delays on the bottom line.
Here are three ways pharmaceutical and life sciences companies can use technology to make their trial more efficient.
1. Infuse protocol designs with more evidence and data
Protocols often wind up being designed with too much exploration and not enough focus3. The primary issue isn’t a lack of data. Rather, there is so much data available, protocol designers can’t possibly absorb it all without a tremendous amount of research time. Artificial Intelligence (AI) technologies can help protocol authors identify real-world patient data and findings in the literature that are highly relevant to their studies earlier in the design process 4. That way, protocols could incorporate better approximations of patient availability and current advancements before the trial proceeds.
2. Use existing patient data to set inclusion and exclusion criteria
Based on IBM’s opinion, without significant experience with a certain patient population, it’s hard to obtain an accurate estimate of how many patients would be eligible for a trial. Tapping into a deep database of patient data would give companies the chance to test their inclusion and exclusion criteria to see how many people would be eligible. From IBM’s point of view, Choosing criteria that set a trial up for successful patient recruitment could help avoid unnecessary amendments and reduce the chances of the sample size being too small.
3. Streamline collaboration
Keeping track of input from stakeholders throughout a clinical trial can be tedious and time-consuming. The difficulty of managing changes across different groups can introduce problems and errors that might not be spotted until after a protocol is finalized and the trial is underway. Software that manages trial tasks could help reduce the pain of working with multiple collaborators by putting all critical information in one central location that all team members can access. Additionally, workflows can be created to streamline communication and automatically notify the owner of each step when it’s their turn to move the project forward, which could potentially save time and resources.
Setbacks are bound to happen in clinical trials, but for a pharmaceutical or life sciences company to improve their chances of advancing a compound through a clinical trial, launching a new medicine and achieving financial success, companies must look for new ways to reduce those delays. The good news is that technology can help, and solutions that can inject real-world data into every stage of a trial or streamline the clinical trial recruitment process are promising avenues.
- “Biopharmaceutical Research and Development: The Process Behind New Medicines.” PhRMA. http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
- Getz, Kenneth. “Improving protocol design feasibility to drive drug development economics and performance.” Int J Environ Res Public Health 11, no. 5 (2014): 5069-80.
- “Real-World Evidence.” U.S. Food & Drug Administration. Accessed June 13, 2019. https://www.fda.gov/science-research/science-and-research-specialtopics/real-world-evidence