Spring is upon us and many of us are hoping for a beautiful forecast for the coming months to venture outside and enjoy warm weather activities. For those of us in clinical research, the forecast for this time of year, or any other time of year for that matter, is often the same…breezy. The unfortunate reality is that for many organizations irrespective of size and resources, the forecast for about half of their clinical trial portfolio spend is just based on a “finger in the wind.” To be clear, it’s certainly not done this way with bad intentions or lack of effort – it’s just what results when you don’t have the right tools and expertise in place to help people execute their jobs effectively. And to make matters worse, this less than scientific approach applies to the single greatest line item in your clinical trial – your investigator grants.
- The investigator grant line item in a typical study ranges from about 40-60% of the total trial budget.
- Most sponsors and CROs struggle with accrual management and cash forecasting for their clinical programs.
- Clinical trial enrollment is not an exact science and can be quite fluid depending upon the program.
- Patient enrollment is the key driver of costs in your trial – with investigator grants as the biggest line item.
- Forecasting investigator grant spend is possible with the right tools and expertise.
Two Main Components of Your Investigator Site Payment Forecast
Patient Enrollment Forecast - There are many complexities and variables to calculating an enrollment forecast, beyond the focus of this discussion. For the most part, clinical teams will often estimate enrollment on a "patient per site per month" basis and extrapolate the forecast taking into account a number of factors including but not limited to:
- The number of sites participating in the trial
- The duration of the site identification process - although I think sometimes this part of the process is under-estimated or simply not considered
- The number of enrollment-ready sites at FPI/FPFV
- The complexity of the patient recruitment - driven by the protocol inclusion and exclusion criteria, type of study, and the therapeutic area of the study.
Enrolled Patients Forecast - It is this forecast that is comprised of “knowns”, but is often extremely difficult to accurately calculate. Consider you and your clinical teams have been diligently working to achieve enrollment on your trial, and you finally have reached your patient enrollment goals. Now, those patients will continue in the treatment period for two years. In this simple example, you should have no problem figuring out your cash flow and accruals for the next two years, right? Truthfully, you have everything you need to forecast your accrual for the rest of the trial:
- The number of enrolled patients
- The exact date each patient's first visit occurred
- The schedule of all future visits according to your protocol flow chart
- The cost for each visit based on your negotiated and executed clinical trial agreement
You realize you have all the information you need, but that’s where the ‘easy’ part ends and reality sets in. While you may have all the data points somewhere at your reach, anyone who has tried to manage the investigator site spend routinely knows that without any robust tools, what you may end up with is an Excel Spreadsheet with more rows and columns than you care to count.
In this perfect world example, you enroll all patients quickly and then just ride out the rest of the study according to the protocol with everyone showing up when scheduled. Even in this simple example, however, it would be a significant effort to forecast and then continuously adjust for actuals throughout the 24 months. Furthermore, if we think about the real world of clinical program execution, sites may be added globally over the course of the study and patient activities may take anywhere from 6 months to five or more years.
Now, as a clinical project manager or senior leader, you are responsible for several different trials and are asked by your finance department on a quarterly basis to let them know what your project cash flow and accruals looks like for the next quarter. You would love nothing more than to give them an intelligent, well-prepared answer but you have spent all your time focused on keeping your investigators happy and preparing for your next investigator meeting. You are frustrated and realize there must be a better way than taking your annual budget and equally spreading the funds.
Forecast Outlook is Positive
The case example above, while discussed for illustrative purposes, is a typical story for many clinical project managers and study team leaders. Whether you are in a top tier pharma or VC backed small biotech, the situation is often very much the same. However, in smaller biopharma, the understanding of your cash flow and accruals for 50% of your clinical trial spend is even more important – as it may drive your next funding round. The good news is that there are solutions now available to help you with your investigator spend accruals and forecasting. In fact, the solutions also come with other benefits like improving investigator relationships and satisfying transparency requirements, not to mention supporting the ongoing financial health of the clinical investigator community.