Greater Phase I Complexity, Greater Phase I Costs
Clinical trial costs have skyrocketed over the past decade with early phase trials showing the greatest per-patient cost increase of any category, on both a raw dollar and percentage basis. In fact, from 2008 to 2013, the average cost per patient increased by $23,600, or by 157%. In Phase I trials compared to an average of 60% across all clinical trial phases¹. One of the driving forces behind the especially dramatic cost inflation in Phase I studies in the increasing complexity of early phase research. As the industry shifts towards personalized medicine and orphan drug development, all stages of clinical research are becoming more sophisticated, Phase I trials especially. In fact, Phase I trials are taking on a whole new role; instead of being used solely to test for toxicity, they’re being used to analyze how patients with varying biomarkers respond differently to a treatment. As such, early phase research now involves more procedures per patient, more numerous and complex eligibility criteria for study enrollment, and longer study duration.
Phase I Spending Saves Money Later On
In the era of molecularly targeted therapies, Phase I trials can be used to identify the subset of patients most likely to benefit from treatment. Though this requires greater spending in Phase I, it actually saves money overall by allowing researchers to strategically adapt recruitment strategies and other study protocol early on. Thus, without increased spending in Phase I, the increase in clinical research costs as whole may have been greater.
Understanding the Five Major Cost Drivers in Phase I Studies
Investing additional funds in Phase I in order to gather early data on efficacy can yield a positive ROI; However, not all spending is beneficial. In order to cut back to wasteful expenditures in Phase I, researchers should carefully consider the major cost drivers in early phase research and seek to eliminate unnecessary expense wherever possible. Read on to learn about the top five clinical trial cost drivers, according to research conducted by Cutting Edge Information ²
1. Staffing: 40- 45%
Staffing is the biggest cost driver in early phase clinical trials, ranging from 40 to 45 percent of the total cost. Phase I staffing costs per patient rose from 2008 to 2013 as companies hired more CRAs per Phase I trial. The staff increase was mainly a result of the increased complexity of early phase trials with a mean number of 00 procedures per patient for Phase I trials as of 2012 to 2013.
2. The Research Site: 15-35%
The research site is the location where subjects are treated and examined. Site costs range from 15 to 35 percent of the total budget. Usually, the CRO or sponsor pays the research site on a per bed per day basis. Additional costs include services like staff surveillance, catering, overhead, and administration expenses.
3. Subject Recruitment: 15-20%
Challenges with incentivizing healthy volunteers to participate in studies and high dropout rates make patient recruitment one of the largest Phase I cost-drivers. Subject recruitment requires approximately 15 to 20 percent of the trial’s total budget. Stringent regulations on washout periods (i.e., how soon a study subject must wait before participating in their next clinical trial) can also add complexity to the recruitment process. Other costs that fall within this category include subject compensation, advertising and screening.
4. Diagnostic Equipment: 12-20%
Depending on the biological compounds involved in the study and the types of tests required, this cost category ranges from 12 to 20 percent of the total budget. The cost includes user fees for large equipment such as ECG machines, PET Scan machines, and cardiac telemetry monitoring devices, as well as lab supplies such as drug testing equipment, thermometers, and blood pressure cuffs.
5. Data Management Tools: 8-10%
Electronic data management tools, which are used in approximately 70% of studies, drive 8 to10 percent of total clinical trial costs in Phase I research. Cost can vary widely depending on the system’s software delivery model, payment model, and ease-of-use. Nimble, cloud-based EDC solutions generally cost less than traditional systems, as they lift the burden of IT infrastructure and licensing fees, and offer software through an affordable pay-as-you-go model. Medrio, for instance, costs about 75% less than traditional EDC solutions. Cost also depends on functionality, which can impact staff hours and study duration. For example, Medrio’s easy to use drag-and-drop study build tool lets researchers build their studies in a fraction of the time it would take using a conventional EDC system. Though some very large and complexstydies may require an expensive custom-programmed solution (e.g., non-cloud EDC), most Phase I studies would benefit from the flexibility,speed, and affordability provided by a cloud-based EDC solution.
Medrio M-1 for Phase I
M-1, Medrio’s Phase I EDC solution, helps customers cut early pase research costs by enabling faster, more accurate data management. M-1 functionalities include rapid study build tools, real-time edit checks, multiple subject data entry, and on-demand data export. Our easy to use cloud-based software helps researchers complete studies faster and costs 75% less than traditional EDC systems (that’s 1/4 the cost!) Try M-1 today!