It’s an exciting time! Your organization is making steps towards initiating the conduct of clinical trials, a process that you recognize is resource intensive. There are myriad moving parts to coordinate and stakeholder questions to address within the healthcare setting where the research site will be housed. Expense is a concern. “Clinical trial costs can vary widely depending on the number of patients being sought, the number and location of research sites, the complexity of the trial protocol, and the reimbursement provided to investigators.” (National Academy of Sciences) While embarking on this venture is a positive step, there are two critical tracks to consider:
1. Strategies to accelerate study start-up
2. How to run your research business to meet the bottom line, while having a patient-centric focus
1. Accelerating Study Start-up Strategies
When you’re initiating a clinical trial, it’s critical to ensure all costs are covered to ensure that your research program is financially viable, as well as successful from a research and data standpoint. It’s more than simply reviewing contracts to determine that the language is appropriate and in the best interest of your organization. Evaluating a trial start-up should include multiple departments to cover each phase of your site’s operations such as:
- Financial feasibility analysis
- Coverage analysis
- Budget development
- CTA language review and negotiation
It is also best practice to address regulatory processing details including:
- Sponsor/IRB required forms
- FDA Form 1572
- Financial disclosure forms
A comprehensive assessment will safeguard that documents are reviewed, revised and submitted accurately and in a timely manner.
To negotiate thorough and fair budgets, be on the lookout for these hidden start-up fees such as:
- Coverage analysis fees
- Pharmacy fee
- Local advertising costs
- Trial set up
- Educational materials and supplies
Keep in mind that once your contract is finalized, the opportunity to reevaluate your budget is still open. Stay in contact with your study team and try to renegotiate any unforeseen expenses prior to enrollment closing. Share your successes and maintain great relationships to ensure your site is in mind for the next trial opportunity.
2. Meeting the Bottom Line
A common factor of successful research programs is that they are managed like a business. To optimize operational and financial success, try to create a consistent workflow:
- Hire an experienced staff and a research finance specialist
- Select and activate trials that have a significant impact on revenue generation, and best fit the patient population of your healthcare setting to ensure enrollment
- An internal budget should be created to evaluate if the sponsor’s per patient offer is sufficient to cover the costs of the trial
- Track study expenses and invoice the sponsor/CRO at the established payment milestones
- Financial compliance is critical; implement a process during the budgeting phase to categorize a standard of care, and research related events in the trial protocol
- Evaluate the overall program for profit and loss to understand where the opportunities and pitfalls are for revenue generation.
If your comprehensive evaluation proves that a particular trial is not financially feasible to your site, let the Sponsor know and be transparent from the beginning. Ideally, your input will help their negotiation on current and future trials and your relationship will be strengthened through this communication.
The Patient Comes First
The complexities of the conduct of clinical research are continuing to scale and following regulatory and business protocols is essential. At the heart of it all is the patient, and the responsibility to provide excellent care while producing good, clean data. GuideStar’s innovative industry leaders bring guidance and support to clinical trials in health systems, AMCs and hospitals. Learn more about our accelerated trial activation services and elevate your organization’s level of excellence in clinical trials.
Post by Melissa Daley -
Melissa develops social media and digital marketing content strategies and produces a variety of collateral with creative, effective messaging. Melissa has served as an educator in higher education for close to two decades.