Breaking Down Operational and Financial Complexity in Clinical Trials

Background

Much has been written about the complexity of clinical trial operations, from the creation of a protocol, through operation, to the analysis and reporting of data. It has also been stated that clinical trials are becoming increasingly more complex, and therefore an ever increasing number of workflows and transactions must be completed before a study can achieve it’s goals.

This post explores operational and financial workflows, and the underlying data that facilitates service delivery. The goal is to offer a glimpse into what the world looks like today, the affects of future trial designs, and solutions that can adapt to an ever changing clinical trial landscape.

Analysis #1: Site Payments

Assumptions:

Let’s simulate a study using some of the tools we’ve built here at Block Clinical. This study is a “hybrid” study with visits occurring at the research site and also virtually. Below are the  parameters used:

  • Timeline:
    • Study Start: Month 0
    • FPI: Month 4
    • LPI: Month 10
    • Study End: Month 24
  • Screened patients: 1200
  • Enrolled patients: 1000
  • Research Sites: 50
  • 12 visits per patient; once per month
  • 7 Visits @clinic/ 5 Visits @virtual
  • Avg. 10 procedures per visit (2x the number of procedures may take place @clinic vs @virtual)

In summary, we’d expect ~12,200 patient visits and the associated activities required to support each visit.

Summary:

  • 75,750 total transactions simulated (indicative of “pay-by-procedure”)
  • Total Spend: $6MM
  • Min. Month Spend: $12,500
  • Max. Month Spend: $766k
  • Total Site Spend: $5.6MM
  • Total Supplier Spend: $400k

Notes:

  • Monthly spend variation from $12,500 in month 2, to $766k estimated spend in month 6.
  • 93% Site Spend
  • Data processed: Site legal entity name, address, tax ID, email, banking information (if applicable)
  • Suppliers
    • Study Management Suppliers
    • Payment Suppliers

Comments

The first things that pops out, whether intuitive or not is the bell curve that follows the natural progression of Site and patient accrual. In many studies, especially multi-year studies, there may be multiple bell curves throughout the trial. This is due to variances in visit schedules. The spikes at the beginning and end of the study are due to startup and closeout costs for suppliers and sites.

For a Sponsor, it’s important to understand the expected cash flow, should the trial accrue sites and patients at the planned pace. This is critical because it allows Sponsors to properly plan and pay for payable activities in a timely manner.

Analysis #2: Site + Patient Payments + Patient Travel

Assumptions

In this study we’ll add patient payments and travel support in addition to site payments. This study is a “hybrid” study with visits occurring at the research site and also virtually. Below are the  parameters used:

  • Timeline:
    • Study Start: Month 0
    • FPI: Month 4
    • LPI: Month 10
    • Study End: Month 24
  • Screened patients: 1200
  • Enrolled patients: 1000
  • Research Sites: 50
  • 12 visits per patient; once per month
  • 10 Visits @clinic/ 2 Visits @virtual
  • Pay by Visit (ie one site payment transaction per completed visit – this is most common)

In summary, we’d expect the same ~12,200 patient visits and the associated activities required to support each visit.

Summary:

  • 80,275 total transactions simulated
  • Total Spend: $20.9MM
  • Min. Month Spend: $7,000
  • Max. Month Spend: $2.3MM
  • Total Site Spend: $8.8MM
  • Total Supplier Spend: $1.7MM
  • Total Patient Payment & Travel Spend: $10.4MM

Notes:

  • Monthly spend variation from $7,000 in month 2, to $2.3MM in month 7.
  • 42% of budget is Site Spend
  • Data processed: Site legal entity name, address, tax ID, patient contact information including first and last name, pickup and drop address, and banking information (if applicable) and tax ID (if applicable)
  • Suppliers
    • Study Management Suppliers
    • Payment Suppliers
    • Travel Suppliers – hotel, air, ground transportation

Comments

This study shows two distinct bell curves. The dip in spend in the middle is attributed to a high concentration of virtual visits. This study includes travel as a scope of service that only applies to clinic visits.

The massive takeaway here is that when you factor in patient travel and payments, the monthly maximum spend is over 10% of the entire budget in one month. If Sponsors are not prepared there could be delays in payments and disruption to trial performance.

But the BIGGEST TAKEAWAY… is the cost of adding patient travel. This may look like a big number, it is, but the thing is it’s always been there. Most don’t see it because the cost is distributed to the 1000 enrolled patients and found in “Misc” line item of patient reimbursement. These same patients have to manage their own travel, pay for and seek reimbursement, while taking time way from family and work to participate in a clinical trial. Eventually the burdens can outweigh the benefits, the result is poor patient retention.

Managed services like Block Clinical provides offer dedicated patient support and strive for $0 out of pocket for patients and caregivers. And because we’ve built dedicated technology you can be assured that we do things as efficiently as possible, saving time and money, and improving quality. We’re focused on providing scalable solutions no matter how complex clinical trial design becomes.

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