Designing and implementing clinical trials isn’t cheap. One report submitted to the U.S. Department of Health and Human Services (HHS) found that the average cost of a Phase 1 trial was $4 million, while the average cost of a Phase 3 trial was $20 million. Considering that up to 85% of all trials experience delays, your budget can quickly balloon out of control.
There’s no way to predict all of the challenges that a trial will face, but there are steps you can take early on in the design process to trim the fat and reduce waste.
1) Invest in a comprehensive feasibility study
Successful clinical trials must adhere to deadlines, hit expected targets, and stay on budget. One of the easiest ways to meet all three of these objectives is to establish a rough outline, or what those in the industry call a feasibility study.
A feasibility study is like a dress rehearsal, in that it encourages you and your team to consider the best geographic location to conduct your research. What’s more, it considers all of the financial obstacles you might face, including site set-up and maintenance costs, investigator grants, and patient reimbursement.
By conducting a feasibility study, you can get a better picture of the total costs, and create guardrails to prevent you from going over budget.
2) Have a thorough understanding of your team’s capabilities
Your team is your greatest asset, but there’s a good chance some of your employees are being underutilized. Instead of outsourcing trial processes at random, call an all staff meeting. When you do, explain the upcoming trial and clearly designate roles and responsibilities. After your presentation, make time to answer questions and respond to feedback.
Likewise, if you plan on implementing new software or other technology during the trial, it’s crucial to provide training. Doing so can reduce headaches and help implementation run more smoothly.
3) Plan for the unexpected
Robert Burns wasn’t lying when he wrote that “the best laid plans of mice and men often go awry.”
The COVID-19 pandemic is a perfect example of this, especially in terms of clinical trials. When governments all over the world shut down to “stop the spread,” so too did hundreds (if not thousands) of clinical trials. Patients suffering from a wide range of conditions, including cancer, dementia, and sickle cell disease were cut off from potentially life-saving therapies.
Though the COVID pandemic is considered a “once in a century” occurrence, that doesn’t mean you can relax. Make sure your trial design includes money-saving features in the event of a natural disaster or another unexpected event.
4) Take advantage of available resources
Many sponsors are forced to balance costs and site-specific issues, due to an increase in multi-country trials. Navigating each country’s rules and regulations is time-consuming and costly. Thankfully, there are resources available to help streamline the process.
Consider the internet-based interactive Costing Tool (iCT). According to Clinical Trials Arena, the program “provides a framework of costs to support budget negotiations for industry-sponsored trials in the NHS. Such a tool allows global sponsors to learn how the UK healthcare system is set up to avoid breakdowns or delays in the budget negotiations.”
Eventually, the industry may develop a more unified global tool. But clinical research experts say that might not be feasible, considering the vast differences at trial sites around the world.
5) Partner with a functional service provider (FSP)
Remember how tip #2 was “have a thorough understanding of your team’s capabilities?” Once you gather that information, you may realize that you require some additional expertise. That’s where a functional service provider (like us) comes in.
At Harbor Clinical, we offer a unique FSP service called the Functionally Aligned Strategic Team (FAST™). Our FAST model pairs you with qualified subject matter experts who can help take your trial to the finish line quickly, efficiently, and at a fraction of what others charge.
To learn more about how we can help keep your clinical trial on budget, click here.
Don’t let budget problems get you down
Budgeting is one of the least glamorous aspects of your job as a clinical trial manager, but it’s absolutely necessary. By following these tips, you can increase your chances of staying in the black.
Would you make any other budgeting recommendations? Please, share your experiences by filling out the online form and clicking the “submit comment” button below.