Reducing the Cost of Phase 1 Clinical Trials
With the cost of drug development always increasing, it’s no wonder that Sponsors are looking for ways to reduce the cost of Phase 1 clinical trials, or that CROs are doing all they can to bid more competitively for that work.
Because much of the work for Phase 1 studies are performed at large clinical pharmacology units, it makes sense to determine how costs can be reduced at that level. By doing so, savings are ultimately passed upward, resulting in overall savings for Sponsors and more competitive bids for CROs.
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 perform a deep analysis of their internal operations and costing exercises, as well as evaluating their practices for optimizing their staff for every study.
Internal Costing Exercises for Phase 1 Sites
It is important for Phase 1 clinical trial units to conduct an internal assessment of their procedural and staffing fees in order to come up with an 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.
How can sites accomplish these internal assessments? There are three basic methods:
1. Using a Grant Plan Software (i.e. IMS Health). These are used by many sites and institutions, especially academic institutions. By using this software, your clinical Phase 1 units can receive insight into how procedures are typically being charged in the market. The data is updated frequently, ensuring that current fair market value is accurately reflected when the costs of Phase 1 clinical trials are determined.
2. Conversations with Pharmaceutical and Biotech companies. There is much knowledge that can be gained by Phase 1 units by simply speaking with their Sponsors for educational purposes. By learning the expectations for costing and the data behind them, sites can ensure that their pricing is aligned with the market.
3. The highest-performing Phase 1 units will regularly perform a detailed analysis on how long procedures take to be completed and compare that data with the rates of the individuals conducting the procedures. By doing so, sites can accurately price out their services at a very detailed level and reflect true costs in their budgets instead of making assumptions.
Furthermore, Phase 1 sites should be considering the specifics of the protocol at hand. Some questions that a site can ask itself when pricing out their services for a particular protocol are:
- Have staff requirements been properly assessed?
- How many cohorts are needed to efficiently run the study?
- What equipment (and corresponding staff) will be needed to complete the study?
- Is the unit set up for an optimal study footprint?
By encouraging clinical Phase 1 units to conduct these exercises and ask these questions for each protocol, Sponsors can ensure that the overall cost of Phase 1 clinical trials can be reduced.
Staff Optimization at Phase 1 Sites
In most cases, sites are using outdated algorithms and blanket assumptions to determine staff requirements. This leads to overcharging and an increased cost of Phase 1 clinical trials for Sponsors. Additionally, sites are typically not evaluating staffing needs uniquely for each protocol.
For example, the time between procedures is an important factor in determining staffing needs. In a 24 patient study, with two minutes between each procedure, then that same staff can be available for a different procedure for the next hour’s timepoint and be utilized efficiently for the day. However, if they conduct that same procedure 5 minutes apart, then a separate staff member will be needed at each hour’s timepoint in order to provide full coverage. Sponsors could be paying to have three to four staff members when one could accomplish the same work if the time between procedures was set correctly.
Phase 1 sites should be aiming to improve their overall operational efficiency. Is the site busy on a particular day and slow on others? On the busier days, is A-team or B-team assigned to the work? This piece alone could influence a number of items for clinical conduct, specifically accuracy, quality of work, and the chance of deviations. If a site has optimized their staff for your particular study, you can be certain that you will receive the best team possible for study conduct which will decrease the risk of unforeseen costs.
When assessing Phase 1 sites, Sponsors and CROs should be certain to obtain CVs of all the staff who could be involved with clinical conduct. It may be difficult to obtain this information from your sites, but it is a necessary measure. You could end up with inexperienced staff or agency workers that are unfamiliar with research requirements, which will likely negatively affect your study, resulting in additional expenses.
By choosing Phase 1 sites which have optimized their staffing procedures at both a high level as well as per protocol, Sponsors can receive the most accurate cost of Phase 1 clinical trials as well as encourage a safe, error-free clinical trial conduct.