Streamlining Site And Patient Management

By Jim Murphy and Sam Whitaker

An emerging paradigm in biopharmaceutical drug development focuses on making patients the center of clinical trials. “Patient-centric” studies are designed in ways that make it easier for patients and sites to complete study protocol requirements in a timely and efficient manner. The convergence of clinical trial technologies is making such efforts possible, particularly in relation to patient compliance and electronic payments to sites and study volunteers.

IVR/IWR As A Hub For integrated Clinical Technologies
The use of common technologies, such as the Internet and telephone, to increase patient compliance, holds great promise for sponsors of biopharmaceutical R&D. Such technologies have been widely adopted globally and require minimal education and oversight to administer in clinical trials. For example, providers of interactive voice and Web response technologies (IVR/IWR) are using email, SMS/text messaging, and outbound calls to remind patients to complete clinical trial-related tasks, such as attending site visits, taking medication, and completing electronic patient reported outcomes (ePRO). Moreover, the convenience of using IVR/IWR drives ePRO patient compliance, since most people have access to either a phone or the Internet to complete diary entries.
IVR/IWR technology is the hub of patient management and an ideal vehicle for patient compliance programs. Used to screen, enroll, and randomize patients, IVR/IWR systems provide a unique opportunity to enlist volunteers in compliance programs very early in clinical trials. Such systems also maintain the patient calendar, which can be tied to the delivery of patient reminder messages and other patient-related study communications. By gaining patient consent for reminder services during the first patient visit and providing multimodal technology options for receiving reminders (text messages, email, outbound calls), IVR/IWR systems are now being used to improve patient management and compliance.

Integrated Payment Solutions
The functionality of IVR/IWR systems can also be tapped to solve an ongoing pain point in clinical trials: administering grants and payments to clinical research patients and sites. The use of debit cards to compensate patients for trial participation can be integrated with IVR/IWR calendar functions so that payments are made when certain milestones are reached during the clinical trial. Patients receive electronic payments at their first site visit in the form of a reloadable debit card. As patients meet certain study milestones, the IVR/IWR system notifies the electronic payment system, which processes data based on study and client specifications before crediting the appropriate stipend payment. Once the card is credited, the patient receives an email or text message notifying them that a payment has been made and the card can be used for purchases.

Similarly, integrated IVR/IWR and payment technologies can be used to pay sites using wire transfers and checks. How does such a system work? The necessary information to transact payments is collected using a simple one-page Web form in the IVR/IWR. As sites reach study milestones, the IVR/IWR notifies the electronic payment technology. The received data is processed against the terms of each site’s contract to pay the site. Payments can be made on a global basis via check or electronic funds transfer directly to the site’s financial institution.

The benefits of integrated IVR/IWR and payment technologies are starting to be recognized by trial sponsors. Among the most notable benefits are:

• reduced administration burden and costs for sponsors, sites, and CROs
• freeing up CROs and sponsors to focus more on their core competencies of collecting data to support regulatory submissions
• more timely payment to patients and sites, relieving financial strains and concerns of both parties during a trial
• improved payment security for the site, patient, and sponsor
• increased patient and site satisfaction
• reduced efforts and costs when compared to current payment practices
• centralized reporting for auditing and regulatory disclosures (e.g. Sunshine Act reporting).

As trials become increasingly global, the integration of payment technologies with IVR/IWR provides enormous opportunities to make clinical trials more efficient and productive.