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International Clinical Trials

Put it on the Card

Web-based payment systems can be used to optimise subject payment in clinical trials and therefore improve patient retention rates, as Samuel Whitaker at Greenphire explains

Approximately 60 million American adults currently do not have a bank account. As a result, the only method of payment available to such subjects participating in clinical trials has been cheques, which can result in fees of five to 20 per cent of the face value of each cheque when cashed. The lack of an accessible and cost-effective method of payment can significantly hamper subject retention, and as research demonstrates, the success of a clinical trial largely depends on successful subject recruitment and retention. It has been estimated that around 20 to 30 per cent of patients drop out of Phase 2/3 trials, resulting in 90 per cent of studies missing their target completion dates (1). Therefore, sponsors would be able to considerably reduce clinical trial costs simply by improving retention. The latest technological developments have led to the introduction of electronic payment solutions, designed to track and monitor trial related payment activities. This article provides an overview of the conventional subject payment process and its shortcomings, as well as discussing how new web-based payment systems are set to revolutionise subject payment in clinical trials.







CONVENTIONAL SUBJECT PAYMENT PROCESS

Paper cheques have traditionally been used to reimburse subjects participating in clinical trials. Nevertheless, this approach is particularly inefficient, cumbersome, timeconsuming and often de-centralised, even when clinical trial management systems (CTMS) are employed. In addition, using paper cheques to process subject stipends creates an administrative burden and results in unnecessary use of limited site level resources. Clinical research organisations (CROs) incur real costs when drafting, distributing, tracking and reconciling paper cheques. A further limitation is that any lost or stolen cheques must be stopped and then re-issued.

A 2010 survey among members of the Association of Clinical Research Professionals (ACRP) revealed that 65 per cent of the investigated sites use cheques as their primary method of payment. Many of these sites pay subjects on a monthly or quarterly basis due to the considerable administrative time required to process cheques. A significant 44 per cent of the sites reported that four or more unique manual administrative steps are necessary in order to process a single payment (see Figure 1). Additionally, it was demonstrated that more than 60 per cent of the sites require 10 days or more to complete the entire process (see Figure 2). In general, it was noted that the amount of time annually dedicated to administering the payment of paper cheques is significant and could be instead directed towards other tasks (see Figure 3).

In response, debit card payment systems have been introduced to address the shortcomings associated with the use of paper cheques.

DEBIT CARD PAYMENT SYSTEMS

Prepaid cards – including general purpose reloadable cards, consumer incentive cards and corporate incentive cards – have been used as a payment solution since the early 1970s. In particular, branded cards have been used as a replacement for cheques for both business and consumer payments (2). In comparison to paper-based payment methods, prepaid debit cards are more efficient and cost less, while also allowing the millions of American adults who do not have a bank account to use a debit card for purchases. These debit cards may be PINprotected, FDIC-insured and subject to consumer protection regulations.

Recent technological advancements have resulted in the development of electronic prepaid debit card systems. These innovative systems offer an efficient alternative to the conventional paper-based payment methods, being costeffective, easy-to-use and improving subject retention. It has been estimated that the use of electronic debit card payment systems also results in considerable administrative time savings, reducing the workload of 2.3 people annually.

WEB-BASED ADVANCEMENTS

The latest innovations in electronic payment systems have revolutionised subject payment and communications within clinical trials by automating site-level and sponsor-level processes associated with paying and communicating with subjects. The new systems function as web-based payment and communication platforms, thus eliminating the need for paper cheques. This is achieved by introducing prepaid debit card technology and manual accounting and reporting of fund disbursement.

By using the advanced web-based payment systems, investigators and study teams are able to determine payment status and efficiently serve patients. The systems can be configured to automatically pay participants based on a studyspecific schedule, make ad hoc payments, or add funds remotely in order to instantly cover travel-related costs for a subject who would not otherwise make an appointment. As a consequence, the systems provide more rapid access to funds for subjects, providing immediate gratification and reinforcing positive study behaviour and increased overall subject retention.

New web-based payment and communication engines incorporate an optional fully blinded multi-level electronic approval system along with centralised blinded reporting capability, thereby enabling sponsors to have full control and auditability over the release of patient payments. In that way, it is ensured that patient payments are made in compliance with IRB or ethics committee approved guidelines for each study. Additionally, site level security functionality may be incorporated to automatically ensure proper payment levels without sponsor review.

As the systems have been simply and specifically designed to fit into a site’s existing workflow, the time to administer and account for patient payments is reduced by an average of 90 per cent. As a result, sites are allowed to focus on more important activities. In addition, electronic debit card systems automatically trigger the execution of a study specific patient messaging programme that delivers electronic messages – including text, email and voice – to patients based on payment activity. Messaging may include payment, appointment and compliance reminders along with any other type of study communication. Consequently, patient attrition is reduced and patient retention is increased.

The use of the innovative systems also ensures that a patient’s funds are secured against loss or theft. If a patient loses his or her card, a replacement may be provided, and if a card is stolen, the patient’s funds are protected by a zero-liability policy. A further significant advantage offered by the newly introduced web-based system is reduced site-level operating costs. Sites using the systems, on average, have reduced costs associated with patient payments by 70 per cent. Cost savings are a result of reduced administration and eliminating fraud risk, reporting duties, banking fees and administration of lost cheques.

As the new systems are directly linked into all required financial networks, patients do not need to deposit cheques or use a cheque-cashing facility, thus eliminating potentially aggressive cheque-cashing fees. Additionally, the overall patient’s experience within the study environment is improved. By providing real-time payments at ATMs, banks, stores and online, patients can access their payment immediately. Finally, electronic debit card systems can easily integrate with any clinical trial management software platform, including CTMS, EDC, IVRS, IWRS and ePRO in order to automatically trigger payments and further reduce administrative burden at the site.

CONCLUSION

The downstream benefits and savings of the debit card payment system provide sponsors and sites with an increased return on investment. The new automated system has been specifically designed to facilitate the efficiency of the payment process and improve subject retention, both through efficient delivery of funds and the associated execution of studyspecific subject messaging programmes. Additional advantages include improved site level administration, technology-driven controls of study, site specific payment schedules and reduction of the site’s cash flow burden. Ultimately, the systems can be integrated with various eClinical technology platforms to provide even greater operational efficiencies.

The new systems have already been adopted by leading pharmaceutical, biotechnology and medical device companies in Europe and North America, and have been implemented as the preferred method of payment by numerous universities and research hospitals including an Ivy League institution. Webbased payment and communication solutions are destined to become an industry standard, and sponsors and site investigators who begin to embrace this system can start to reap the benefits.

References
  1. 1. Adinamis G, Proof Positive Results, Next Generation Pharmaceutical 15: p144, 2009
  2. 2. Kermani F and Findlay F, The Pharmaceutical R&D Compendium, 2000


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Sam Whitaker currently serves as Greenphire’s CEO. He founded Greenphire in May 2008 with the goal of creating a streamlined, web-based payment and communications solution for the clinical research industry. Sam previously worked as a Vice President of Product Development for Citigroup’s prepaid card division. Prior to working for Citigroup, Sam spent several years working in transactional finance. He earned a BA from the University of Pennsylvania. Email: samuel.whitaker@greenphire.com
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