Reducing the Cost of Phase 1 Clinical Trials
With the cost of drug development always increasing, Sponsors are actively looking for ways to reduce the cost of clinical trials, even during Phase 1. Because many Phase 1 studies are performed at large clinical facilities with augmented clinical staffing requirements and with volunteers that have higher expectations for stipends, it makes sense to determine how costs can be reduced at this stage. By identifying ways to reduce costs at the site level, savings are ultimately passed upward, resulting in overall savings for the program.
But how can Sponsors and CROs ensure that they are receiving the best value possible from their current clinical Phase 1 units? What can they do to guarantee the best value from any new sites that will be added to their shortlists? The answer lies in encouraging sites to examine their staffing and cost assignment models such that they are in line with the needs of the protocol at hand.
Internal Costing Exercises for Phase 1 Sites
It is important for Phase 1 clinical trial units to be able to justify their budgets and ensure appropriate fair market value for their Sponsors. This exercise requires extensive research, so some sites may need more guidance or assistance than others in order to complete. But by taking these measures, Phase 1 sites can more accurately price out their services for Phase 1 studies, ensuring that Sponsors aren’t being charged more than necessary and that CROs can identify sites that are allowing them to bid more competitively on potential work.
What should Sponsors and CROs look for when evaluating a Phase 1 clinical site’s budget to determine areas where a cost reduction may be appropriate? The below is a list of the top 5 considerations when evaluating budgets for potential savings.
1. Budget Detail
Phase 1 sites should be able to produce adequate budget detail that shows how certain costs are included in larger line items. A budget that follows the outline of the Schedule of Events (SOE) is an easy way for Sponsors and CROs to see how a “per patient” budget is created. This also allows Sponsors to identify high value procedures or line items that stand out, and to inquire about those fees.
Sites should be prepared to provide detail around how those items were derived, including a breakdown of time, materials, and the methods that make up those fees. If that level of granularity is not provided, there may be an opportunity to assess these items more closely and identify how they can be reduced.
2. Staff and Investigator Fees
The site should be able to explain the staff resource model used to derive the fees. Inquiring about this will demonstrate whether the site understands the type of staff, the number of staff, and the hours per staff member required to manage the trial at any given study.
Phase 1 trials can be procedure intensive and may require many staff to successfully conduct a busy PK or dosing day, but the budget should also account for the slowdown in procedures as the study progresses and the reduced number of staff that will be needed. Both Sponsors and CROs should look for this level of variability. Sites that take the time to assess the time and training necessary to perform various procedures will optimize staff assignment at a high level and on a per-protocol basis, which will be reflected in the budget that is provided. If the site uses blanket assumptions to determine staffing requirements, this can lead to overcharging for the actual work performed.
3. Cohort Size
Phase 1 trial units should be able to demonstrate cost efficiencies as cohort sizes scale up. When the budget is presented, the number and assumed size of cohorts should be clear. Ask the site to identify those areas which are directly tied to the number of volunteers in a cohort versus items which are fixed costs to see how the budget might be impacted if the number of cohorts or the volunteers in each cohort fluctuates.
4. Pass-through Fees
When reviewing the budget, evaluate the pass-through fees carefully to ensure that:
- The site has carefully thought about the items that are necessary to ensure a successful and efficient trial
- The site is making logical assumptions that give an accurate estimate on all units and associated costs involved in the trial
One example we like to cite here is in the use of “alternate” subjects for First-in-Human (FIH) studies. In order to run a FIH trial effectively, Sponsors need to ensure that full cohorts can be recruited and enrolled at each dose level. Missing the full cohort enrollment by even one or two subjects means that a “mini cohort” needs to be enrolled, which may extend the timeline and increase the overall cost of the trial. Having an adequate number of alternate subjects checked-in to the site prior to dosing will ensure full enrollment at each dose level and minimize the risk of change orders or extended timelines.
5. Request Sites to Provide Consultation
One method of reducing costs in the trial is to query the Phase 1 unit on ways that the study endpoints can be obtained in a more cost-effective manner. Examples might include:
- Removing unnecessary procedures, including during subject screening
- Swapping staff resources required to perform certain procedures or assessments for less costly personnel (assuming less costly personnel are adequately trained)
- Using a different method to obtain a certain endpoint
By asking the site to advise on these items, Sponsors are often able to find cost reductions as well as test the site’s thoughtfulness when creating a strategy for conducting that protocol.
Beyond the above tactics, a Sponsor or CRO can test a site’s budget by utilizing a Grant Plan Software (e.g. IMS Health). This software provides data that is frequently updated and can give an idea of current fair market value associated with procedures. A Phase 1 site that prices procedures far above fair market value should be able to justify their rationale for doing so or be open to negotiation.
In conclusion, reducing the cost of Phase 1 clinical trials is an exercise that can be performed by all parties—by the Sponsor or CRO when evaluating transparency, granularity, and variability in a budget; and by sites when examining their strategies for costing and resource management. We feel that by encouraging this level of conversation, all stakeholders involved in the conduct of Phase 1 studies can benefit from having clearer communications and expectations while partnering.