Lauren Miceli, Digital Marketing Specialist, Bio-Optronics, Inc.
In the world of clinical trials, researchers and patients often approach studies from different perspectives. Researchers want a successful go-to-market product or publishable finding; patients want to know how the study will help their health, and how much they will get paid. This disconnect can be problematic when it comes to ensuring accurate and timely patient payments.
Many research facilities may not be as attuned to patient payments as the patients themselves. The day-to-day focus of clinical trial teams includes data recording and analysis, a collaboration between researchers, quantifying results, and more. While this makes sense from a logistical perspective, that doesn’t mean accurate and timely patient payments should be ignored or dismissed.
Here are best practices that any site can utilize when it comes to patient payments to minimize payment challenges, ensure patient satisfaction, and deliver a successful trial.
Set Site-Wide Payment Standards
Research regulations almost always focus on issues of patient safety, consent, analysis, etc. Each of these components is highly regulated and managed through standard operating procedures due to it having a direct effect on patient safety and site accountability. These highly detailed standards often fall short in the area of patient stipends. There are limited payment setting, processing, and monitoring guidelines in place. This lack of regulations means sites are on their own when it comes to payment processing.
A good first step is defining your site standards and ensuring key staff are aligned to them. Identify critical payment components like payment amount structure or payment processing procedure, and develop a concise guide for each. Enlist all critical members of the team from different departments to ensure the plan is comprehensive and executable. Once the plan is final, share it with all sites and study teams and schedule annual information reviews and re-dissemination.
Mitigate Missed Payment Challenges
Clinical trials are reliant on patients being available for the duration of the study. Depending on how stipends are paid, many sites offer compensation at the end of the trial, even if stipends are distributed throughout the duration of the trial. However, if a patient fails to show up – for any reason –– that money can’t be reclaimed by the research site. As a result, hours can be wasted trying to track down patients, ensure payments, and track those payments for audits by trial sponsors. If that can’t be done, the money will essentially be in limbo until the participant claims it.
Overall, it’s imperative that research sites have reliable methods for both paying patients as well as ensuring participation. Clinical trial management system (CTMS) integration can significantly reduce this hurdle because of the controls it puts in place for patient tracking and reconciliation. Missed payments can be identified in real time vs. at the end of the trial. Digital records also enable site managers to do self-audits on all funds that enter or leave, making it easier to clearly see where there might be incongruities.
If you asked research patients how they would like to get paid for their participation, most of them would likely say that cash is ideal. However, for a research site, paying cash can be problematic, especially because it can be so hard to track.
There are a few problems with cash; money can be stolen easily, and transactions must be manually entered into the system. Finally, trying to audit patient stipends can become problematic, especially if the data weren’t entered correctly. Checks are a slightly better solution, but they still entail many manual touchpoints.
The ideal solution is a pre-loaded and re-loadable debit type card. Incorporating this into your sites enables integration with your CTMS and supports patients’ needs to have readily available funds that can be used anywhere that cash is accepted. Payment cards also allow for easier standardized payments, tracking, and adjustment based on each study’s specific protocol.
This disconnect between researchers and patients in the area of patient payments can create a variety of challenges. Make sure there is a shared understanding to help mitigate payment issues. Ensuring site staff understand participants’ motivations and goals from the beginning of the study is a good place to start. Clearly defining how and when payments are made will help alleviate any potential patient concerns, making them better partners for the duration of the study. And, if payment issues do arise, having a system that can quickly identify the mistake and correct it will go a long way toward patient satisfaction.
Even if you’ve constructed a fully transparent payment structure and shared that with patients during their enrollment, that commitment to sharing information should remain throughout the trial period. Since the clinical research landscape is always changing, research sites can (and do) alter patient payments during a trial. Stipends can be increased, reduced, or eliminated entirely. While these adjustments may be necessary, it’s imperative that they are shared with the patients as soon as possible.
Ensuring that the standards your site has developed are read and understood by patients is a critical step. Creating guidelines will ensure that everyone involved has a shared understanding and can eliminate any ambiguity about expectations.
That said, a research site may not always know what to expect during the life of a study, so making promises about stipends is risky. Researchers can let patients know that stipends may be subject to change or alteration. If participants are notified when a change occurs, it can alleviate any tension or backlash that would otherwise arise.
Incorporating payments into your CTMS reduces one of the most significant pain points for administrators. This is exacerbated with patient payments because of the sheer number of subjects in any given trial. Leveraging your CTMS for payment tracking is an additional value of that system. By utilizing digital payments, these transactions can be recorded and audited quickly and efficiently.
Improving your patient payment protocol is easier when there is a comprehensive CTMS in place. If you would like to learn how implementing a CTMS can provide easier processing and tracking and deliver higher patient satisfaction, stop by booth 134 at ACRP 2019!