Dinesh Kashyap

Dinesh Kashyap

8 Key Challenges to Clinical Trial Budgeting3 min read

Bringing a new drug to the market is an expensive venture and can take up to 10 to 15 years from discovery to launch. Clinical trial costs are increasing and so is the complexity of managing it. According to the Tufts CSDD March 2019 Report, Sponsors are spending more on CROs for developing new medicines rather than their own internal team and infrastructure.

  • Sponsors spent an estimated $86 billion on all contracted R&D services during 2018, surpassing internal staff and infrastructure spending by nearly $20 billion.
  • Sponsors employ a variety of outsourcing approaches simultaneously, including transacting for individual tasks, full-service, and functional/program service relationships

Budgeting for clinical trials can be a complex process with multiple variables that need to be properly accounted for and managed as assumptions. The following are the top challenges in the budgeting process for clinical trials:

  1. Timeline delays
    Delay in timelines caused due to failure in meeting enrollment deadlines, changes in the trial design, etc. lead to variations (which can sometimes be as much as 40% of the planned budgeted amount) in the planned budget and actuals.
  2. Legacy Systems
    The Industry is struggling with excel based systems and spreadsheets to monitor and manage finances. These spreadsheets require manual reporting, difficulties in sharing, consolidating and extensive time and effort in re-keying the data into different systems. Generation of payments and receipts cause a mismatch in the amounts leading to significant effort in reconciling the mismatches and being audit proof.
  3. Lengthy negotiation process
    The contracted rates and study specific Budgets can go through a long negotiation process and can impact the overall timelines and enrollment objectives of the study.
  4. Complexity in Outsourcing
    Clinical trial processes are increasingly being outsourced to multiple CRO’s as Sponsors are trying to reduce the risk of dependency on few CROs and looking at multi-vendor outsourcing in terms of CROs specialized in recruitment, clinical operations, etc.. Sponsors even change the CRO’s mid-study when the fluctuations in budget and actuals are high, timelines are crossed, enough patients are not enrolled in a specified time.
  5. Lack of Integration
    Lack of System Integration between the various systems used by both the Sponsors and CRO’s create decentralized data resulting in manual effort, time and costs in consolidating and reporting.
  6. Unscheduled events
    A sudden patient visit or a procedure or any such unscheduled events are unavoidable and these incur costs that are not usually covered in the budget.
  7. Trial complexity
    Complex trial requirements such as stringent inclusion and exclusion criteria lead to fewer potential participant groups to be targeted for enrollment. Any consequent amendment to protocols would also lead to an impact on costs and timelines.
  8. Lengthy submission timelines
    Regulatory submissions are tedious and lengthy. Depending on the various activities performed and the IRB’s used, the submission, review and approval timelines and costs could vary.

Conclusion

The increase in Industry-Sponsored trials, Clinical sites are on the verge of looking to cut costs. There is a high unmet market need for a centralized automated solution to handle budgeting aspects such as billing and administrative functions. Clinical trial budgeting has acquired significance and plays a pivotal role to achieve the financial objectives and to drive operational efficiency.

With the right budget management solution, the budget created can be easily shared, submitted, reviewed and approved by any assigned authority, with an ability to set up process flows and approval process with a simple point and click steps. The solution provides complete audit tracking capability with details like what fields were changed on what date and by whom etc.

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