Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. This installment in our Clinical Research 101 series is by Leslie Love, Senior Project Manager at Advancing Health. Ms. Love is a certified clinical research professional with over 25 years of experience in a variety of research settings, including at the site level, with sponsor-investigators, and at contract research organizations. The following is Part 2 of a discussion of how to budget for a site for a clinical trial — you can view Part 1 here.
While there are several strategies for funding clinical trials, in practice, the two most commonly used models are activity-based funding and payment-based funding for relevant positions within the research study. Both have their share of benefits and drawbacks.
Types of funding models
Activity-based funding, which often applies to health care providers like acute care hospitals, entails funding based on care and services administered. We see a similar strategy used during industry-sponsored clinical trials, where companies provide funding to research sites based on participant enrollment and research procedures performed. One of the downsides of this retrospective payment model is that payments are often made long after study visits occur. So, a site that is unsuccessful in recruiting participants might wind up in the red. When using this funding model, it is imperative to ensure that upfront payments are stipulated in the contract.
The second funding model, called payment-based funding, involves paying for a percentage of a clinical research position (e.g., a research coordinator). This strategy is effective when the study does not require many hospital-based tests and procedures. For instance, a study is expected to need a full-time coordinator. The annual cost for a study coordinator is paid up front, and any specific procedures and pass-through costs are billed and paid for separately. This practice is generally seen in academic research. In some cases, positions are shared if multiple research studies are happening in one particular area, like an emergency department. This allows for continuity and variety of positions, and coverage for absences.
Types of Expenses
When investigators take on the role of “sponsor–investigator,” where they act as the sponsor and the investigator at a site, there are further costs associated with running the study across one or multiple sites, and these need to be included in the budget.
In these circumstances, it may make more sense to budget based on a full-time equivalent (FTE) for study sponsor staff, which could include, for example:
- Research Project Manager 1.0 FTE (oversees study, and ensures study is conducted efficiently, ethically and in compliance with regulatory standards, liaises with sites, vendors and study team members)
- Data Manager 0.5 FTE (set up the study database, and review the data as it is entered) *
- Statistician 0.2 FTE (for protocol development and analyses)
- Knowledge Translation 0.1 FTE
Other possible positions required when acting as the sponsor–investigator include a study monitor, regulatory support, or medical writer.
*Some institutions may offer faculty or staff access to databases or data management tools.
How to negotiate a study budget at the site level with an external sponsor
Negotiating a study site budget can be an intimidating and time-consuming task. Sponsors often have a target budget for each site within a clinical study, but not all sites have the same expenses or costs, which means you need to justify costs.
Having a list of institutional costs (e.g., lab tests and REB review fees) can be helpful. But you should be prepared to accept less for one item in some instances, as long as you can make up for it with another item. You should also be aware of what issues and items are most pressing for your site. For example, if you’re based in a downtown hospital in a central location where the parking fees may be significant, you’ll want to ensure that the fees are included in the participant compensation.
Some sponsors will want to see every line item in the budget, while others will only want to see the total figure for each visit. You should account for both of these possibilities to ensure that all costs are covered.
Accounting for cost variability
Costs associated with a study can vary considerably based on the following factors:
- How complex is the study? Consider the cost of extra resources (staff time) for a more complicated study.
- How difficult will it be to enroll participants? And retain them in the study? Consider allowances for advertising and engaging participants.
- What is the participant compensation, and is it reasonable for your location and the time the participant spends with the study coordinator?
- Is there likely to be a lot of serious adverse events? If yes, consider the actual administrative costs for additional data collection and reporting.
- Is there likely to be many protocol amendments?
If you find yourself navigating serious adverse events or protocol amendments, you should ensure you are compensated for each of these events. Some important things to remember:
- Make sure to secure an upfront payment (start-up fee) for the administrative costs/work conducted before the study begins.
- Ideally, one full upfront participant visit payment is provided to the study team that can be refunded if no study participants are enrolled.
- Ensure the payment schedule is fair and frequent enough to maintain cash flow. This requires considering factors like what triggers payments, the turnaround time, payment methods (for instance, cheques are much slower than e-transfers, although fewer and fewer organizations are accepting payment by cheque), and the currency used (US or Canadian dollars).
- Try to ensure the payment schedule is not based on activity outside the site’s control, like the sponsor’s review of data, or monitoring visits.
- Lastly and most importantly, know when to decline a study. Sometimes, a reasonable agreement cannot be reached.
References and Resources
- How to Negotiate a Clinical Trial Site Budget, by Sue Willems and Judy Needham, CRPBC Presentation
- Activity-based funding | CIHI
- Activity-based funding | Healthcare Funding
- How to Budget for a Clinical Trial | CCRPS
- Negotiating Clinical Trial Budgets, Debbie Williams
If you have any questions, please contact researchsupport@advancinghealth.ubc.ca, and we can assist you.
