Dave Espenshade

	Recruiting a participant for any clinical research is difficult, but when it comes to Phase 1 studies, it can become even more complex because these studies require healthy patients to volunteer to determine the safety, tolerability, and pharmacokinetics (PK) of a compound.

	Stipends are critical in Phase 1 Clinical Trials, ensuring participants are properly compensated and retained throughout the study. It’s no surprise that, at Greenphire, we typically see largest stipend amounts in this phase of research. These large stipend amounts introduce a risk if the distribution method is checks or cash. Not only are these methods not auditable or secure-they tend to also introduce a great deal of manual burden and delay to getting the participant their compensation.

	The challenge that Sponsors and sites face is selecting an appropriate payment method to maximize retention, and keep the site operations team focused on patient care, not administrative tasks. 

	The number of patients for a First in Man trial is low (usually under 100)

, but the volume of active trials in this stage is high. Some large CRO and sponsor Phase I units conduct up to 100 studies each year. With the average trial requiring 3-5 payments per patient, the administrative burden placed on coordinating and tracking patient payments is significant. 

Traditional Methods Are Risky and Impact Retention

	Due to the large volume of payments in Phase I trials, traditional cash or check reimbursements are unrealistic and risky. Phase I trials can pay up to $2,000 per patient, or more, making it difficult for sites to keep the appropriate amount of cash on hand.

	Paying by checks also brings challenges. For sites, the amount of administrative work required to pay by check means strained resources; and for patients, the manual process can mean waiting weeks or months for payment to arrive and requires a trip to the bank. An added frustration to subjects is that a significant percentage may not have a bank account so end up paying very high check cashing fees. Putting an inconvenience on the patient can put retention and ongoing engagement at risk.

For decades, the industry has had a culture of risk aversion, keeping things in-house and not breaking away from the status quo. Today, CROs and sponsors are beginning to realize the benefits of these technologies for all parties. Industry-wide, cloud-based technologies are no longer deemed an unnecessary danger and electronic health records (EHRs) are no longer a bad word. The same rings true when it comes to payments.

	Sites are realizing the benefits of paying with reloadable debit cards, a process consumers come to expect with financial transactions. In fact, a Federal Reserve Payment Study found that in 2016, 65.9 billion debit payments were made, valuing $2.56 trillion.

 Paying patients via debit card offers the opportunity to enhance the clinical trial experience and increase retention. Designing trials to keep patients happy and coming back is especially vital in Phase I trials, in which the patients are not looking for treatment for a personal condition.

	Phase I studies have short timelines-often only a few months

-resulting in a tremendous amount of administrative work for the coordinators and study staff within a short period of time. The quicker the study moves, the quicker the payments have to get processed, which is difficult when working with cash or checks. Reloadable debit cards simplify the reimbursement process, enabling sites to focus on the execution of the trial.

	Security is also big concern and a key decision driver for sponsors and sites. Typically, Phase I study sites pay subjects by checks, which requires the site and financial support teams to process them numerous times each month, or petty cash, which requires frequent deliveries of cash to the site. Using a debit card centralizes all transactions, eliminating the need to keep cash on site and removing any risks of check fraud or lost checks.

	When paying by cash or check, it can take numerous processes and involve many departments to complete single patient payment. That number can be minimized to 15 seconds per patient when using an automated solution. Centralizing and automating stipends and payments not only makes the payment process faster and easier, but it can also improve clinical trial compliance. Sites can conduct multiple studies at a time, leaving little time for managing payments and ensuring that their sponsors have the most accurate, up to date information. When participant payments are processed electronically, sponsors and sites are viewing the same information in real-time, delivering maximum visibility into the trial payments and confidence that they are controlled and precise.

	Phase I studies are especially sensitive as subjects and researchers do not know what to expect when a new drug or therapy enters the subject’s body. Automating the subject payment process empowers Phase I clinical research site staff to focus more time on the subjects, ultimately providing a better trial experience for all involved. A positive experience is important to have patients continue to enroll in future trials.

	As the year progresses, we anticipate we will continue to see CROs and sponsors adopt this method of payment.

https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

http://www.businessinsider.com/7-things-to-know-before-joining-a-clinical-trial-2012-3

https://www.creditcards.com/credit-card-news/debit-card-statistics-1276.php

, Vice President, CRO Partnerships, Greenphire

Articles

The adoption of automated payment methods for phase I trials will allow for more effective clinical trials.

Author | Dave Espenshade