Clinical trial site finances: Tips for budgets, payments and invoicing

In this series - The Pain Clinic - Kate O’Brien, formerly a senior research nurse and now a site consultant, examines the most common problems facing clinical trials today and what the potential solutions to them are (read the previous posts here). This week she looks at sites finances, payments and budgeting. 

Personally, I found dealing with finances, from budget negotiation to reimbursing patients, one of the most frustrating areas of my job and discussions with other experienced research nurses suggest that this is a common issue. This article will look at some of the areas that cause headaches.

Budget negotiation

Despite having a standardised costing template this still requires verifying for complete correctness. This means cross checking against the contract that all procedures have been included and have been allocated to the correct role in the study team. Then each procedure needs assessing for the amount of time that it will take, and it is often this area that causes issues. Whilst the procedure itself may not take long, companies do not allow for the fact that sites are dealing with real people who ask questions when completing questionnaires, make mistakes that need to be identified and corrected, and also need to get undressed for physical examinations and ECGs.

There is also concern that experienced sites who can accurately assess timings and costings can be undercut by less knowledgeable sites who are keen to take on more trials.

Patient payments

Personal experience has led me to believe that surprisingly this seemingly easy area is one that can cause the most difficulty. There are several ways that payments can be made:

Cheque – now old-fashioned and means a trip to the bank for patients.

Bank Transfer – some people are cautious about who they release their bank details to.

Cash – this either involves the study team holding their own float or obtaining the required amount from their finance department. The first instance means that a secure storage is required, and time is spent balancing the receipts. The second is the method I was familiar with, but this entailed notifying the accounts clerk of upcoming visits and the amount required to ensure that they had enough funds available, collecting and signing for the cash, and returning it if they patient failed to attend. Enough hassle on its own but if you are unlucky enough to have an uncooperative accounts clerk…

Patient Payment systems – I admit to being sceptical when first hearing about these methods! However, my Research Interest Group agreed to hold a focus group providing patient feedback on the ClinCard system for Greenphire. They highlighted some very important issues. They wanted secure ways of carrying their payments and felt that a card system is safer than cash. It allows them to track their receipts so that there can be no concerns over missed payments. Some patients liked the idea of an easy method of saving up an unexpected income for a special occasion or treat. Finally, it was transparent if they need to declare this to the inland revenue. From a site’s point of view, it is quick, easy to use, transparent, and allows for those awkward amounts if a patient uses taxis. They were all very enthusiastic about this as a method of payment.

I repeatedly relayed these findings to companies when setting up trials, who all displayed an interest. However, this was never taken forward and we remained with the same old problems, convenience for the companies, and a headache for the sites!

RELATED POST: Can clinical trial patient concierge and reimbursement services improve engagement?

Invoicing

As a rule, the amount is calculated by the CRA/company and the site is requested to raise an invoice. However, this still requires checking for accuracy and completeness. This involves cross checking against the amounts agreed in the contract, the visits completed, and the tasks included. Payments to patients and external providers need to be factored in.

If the site is required to complete the whole procedure this can take a great deal of time. Spreadsheets are very useful to track visits, payments made and specific items that need to be included. However, this relies on all staff completing these accurately, if not it adds to the workload of the person generating the invoice and payments can be missed.

Once the invoice amount is agreed it then takes time for the account to be settled dependent on the policy of the company involved. I found this varied enormously and had to be conscious of checking that payments had been received.

It is strange that in an industry dealing regularly in multi-million-pound sums, so little consideration is given to the end user. It seems to be generally accepted that sites are happy with invoicing at a minimum of three-monthly intervals and can wait even longer for payment. This is not the case; most sites have a limited cash reserve. This often impacts directly on a site’s ability to continue to conduct clinical trials if delayed payments affect their operational cash flow. Finance related issues can take up a considerable quantity of time that would be better directed at patient focused tasks.

I found it difficult to understand why Sponsors did not utilise the automated invoicing systems that are available. These provide prompt payment, are transparent and enable sites to manage their cash flow. Time spent administering accounts is time away from recruiting and caring for patients.

There are two excellent whitepapers by the Society of Clinical Research Sites in collaboration with Greenphire highlighting the importance of this topic. Financial Barriers to Site Sustainability, Patient Experience and Overall Trial Success (Feb 2019) identifies limited operating cash, the manual invoicing process, untimely payment frequency and lack of financial transparency as the four main areas of concern. This flags that this is a global issue for sites and impacts directly on their ability to function effectively. Site Payments and Patient Reimbursement - A Global Perspective (Apr 2017) again demonstrates this. A future article for this series talks to two top investigators, involved for over 25 years in conducting trials at the highest level who have both now ended their involvement citing financial stresses as one of their reasons.

I would urge Sponsors to investigate the use of automated site payment systems and patient reimbursement methods such as ClinCard. Remember that we are primarily doctors and nurses and our skills are in patient focused areas. By maximising efficiency at sites we can shorten timelines and therefore overall costs. This also helps to maintain job satisfaction, keeping the high quality investigators engaged for the future.

Kate O’Brien is taking part in a panel titled 'Taking part in a trial - Myths and Reality' at Clinical Trials Europe in Barcelona on 20 November. Explore the full agenda here.