Frequently, when sites ask for changes in a clinical trial budget, they get a response back that “it’s the site cost of doing studies” or that “it is covered under overhead”.
These responses are often given when reimbursement to the site for monitoring visits is requested. However, monitoring visits have never been covered by “overhead” (Overhead is rent, heat, air conditioning etc., not clinical trial specific items that vary study to study). At one time, it seemed acceptable that accommodating monitoring visits is part of the cost of doing clinical trials. However, that perspective is no longer accurate considering how clinical trials have changed over the last 10-15 years.
Sites are increasingly asked to do more in clinical trials and the study budgets haven’t increased along with the additional responsibilities.
If sponsors and CROs want to improve clinical trials and remove barriers to participation, monitoring visits should now be a line item in every clinical trial budget.
The Why:
- Hosting a monitoring visit impairs the ability to conduct participant visits. Fewer visits must be scheduled that day to accommodate the monitor’s visit. Fewer participant visits = lost income.
- The more complicated the study design, the more complicated the monitoring visits.
- Every monitor requires something different at a monitoring visit. Even within the same sponsor or CRO, sites often must cater to the individual needs of the CRA to get through the visit.
- While on site, the monitor is taking up space that consumes resources and cannot be used for something else that will generate income.
- Monitoring visits are a line item in CRO budgets with sponsors. CROs get paid for the work done pre, during & post monitoring visits. The site also has work pre, during & post monitoring visits that should be compensated.
- CRA changes are expensive to sites. Usually, the new CRA comes in and requests changes because the previous CRA missed something or gave different instructions. This is incredibly time consuming.
- When monitoring visits do not happen frequently enough, the work for the site increases exponentially.
- Studies that have “unblinded drug dispensers” often have unblinded monitors. Double the monitors = double the work.
- When monitors don’t keep up with monitoring study drug, the site ends up storing the drug for additional time. Unnecessarily storing study drug is an additional cost and risk to the site.
- Sometimes monitors bring associates with them. More people = more expense to the site.
- Simply put, in a system that touts “fair market value”, sites should be compensated for all aspects of a clinical trial.
Advice for sites:
- Track the amount of time spent preparing for a monitoring visit, assisting / meeting with the monitor during the visit and any follow up after the visit. You need to know your costs in order to propose this as a line item in the budget.
- Request line item budget fees for monitoring visits
- Request additional fees for remote monitoring visits. They cost more for the site to conduct than in person visits.
- Request additional fees if there are multiple monitoring teams – for example for unblinded monitoring.
- Request fees for every time a change in monitors occurs.
Dealing with responses from budget negotiators:
- “Our company does not provide compensation for this”. Respond and ask why not. It’s an expense for a site directly related to the clinical trial and it should be covered.
- “It’s a requirement for all studies, so we don’t accept it as a line item”. Respond to educate that conducting an informed consent discussion is a requirement for all studies and is paid for in a clinical trial budget. The site doesn’t have the resources to provide services for free.
- “It’s covered by other fees in the budget”. Respond and inquire which other fees cover monitoring visits. It can’t be the start-up fee because that is specific to the start-up activities. A potential compromise may be to add an annual administrative fee in an amount that would cover monitoring visit costs.
You may or may not be able to secure additional fees for this item, but it’s definitely worth requesting for each study.
Best of luck and let me know if you’re successful.
Clinical Research 
Leave a comment