The FDA may require a post-approval study (or studies) at the time of approval of a Premarket Approval (PMA), Humanitarian Device Exemption (HDE), or product development protocol (PDP) application to help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device. Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.
As drugs and therapies continue to advance, there has been an uptick in PAS. For example, in 2014 more than 13% of total R&D spending by pharma and biotech firms was focused on conducting PAS.
PAS can last for years, even a decade or more. Minimizing patient dropout is key to the success of these studies – but can become extremely difficult when a patient is asked to participate in a long research study, filling out surveys, questionnaires and sharing personal information about the effects of the medication or treatment. Participants often lose interest in participating, resulting in a never-ending cycle of recruitment and retention efforts from the investigators and clinical trial sponsors.
One way research sponsor companies are addressing patient retention is by offering monetary reimbursements to participants through the easiest, most preferred method for subject reimbursement – a reloadable debit card backed by a sophisticated technology platform.
There are three key reasons why this solution is uniquely designed to support these studies:
- Proven ability to retain patients
- Unique messaging and communications platform
- Unprecedented reporting and tracking capabilities
The average dropout rate among all clinical trials is 30 percent. In post-approval studies, this is amplified. Over the course of a study, patients must spend countless hours participating in trial activities such as filling out surveys, partaking in focus groups and engaging in follow up calls to discuss their drug or therapy. Reimbursing participants for their time in this effort is critical. While some investigators choose to reimburse with cash or checks, patients prefer receiving reimbursements through a reloadable debit card.
With the card, the funds are received immediately – a check could take weeks to receive in the mail. Additionally, PAS follow ups are not always conducted in person, so receiving cash for participation is not an option. With the reloadable card, a participant can receive funds once the activity (whether that be a visit to the doctor or participation in a survey) is completed. That instant gratification is key to keeping patients engaged – and has even been proven to increase retention by 10 percent or more.
The benefits of a reloadable debit card don’t stop with the patient. The manual work associated with distributing petty cash or writing checks can be error prone and burdensome for the staff at the investigative site. This effort is eliminated with a reloadable debit card – empowering research staff to authorize reimbursements to participants with just a few clicks on a portal. Additionally, the funds are secure and traceable. In the event the card is lost or stolen, the funds can be replaced, which is not possible with other reimbursement mechanisms.
A reloadable card solution backed by a sophisticated technology platform that allows investigators and trial staff to send appointment reminders to patients or even notifications that their reimbursements have been loaded onto their card is extremely valuable. While this sounds like a basic feature, these simple touch points are repeatedly referenced as key factors to continued participant engagement.
Unprecedented Visibility and Control
When there are millions of dollars spent to bring a drug to market, and even more invested in Phase IV studies to keep a drug or treatment in market – bringing a level of controls and visibility to financial transactions for study reimbursements is extremely valuable.
At the investigative site level, doctors eliminate the unnecessary time and resources associated with the manual efforts of issuing, tracking and recording checks and cash. Automatically dispersing a reimbursement or stipend for research participation allows the staff to get back to focusing on patient care. Additionally, with a centralized platform that aggregates all reimbursement activity, investigators can report activity back to their sponsor or CRO partner quickly and easily. This technology can even simplify tax reporting requirements in the event a study participant needs to claim the funds received for their participation in the research.
At the CRO and sponsor level, when patient reimbursements are automated, not only are the investigative sites put in a better position for success to support the research, there is clear visibility into the site level activity that has previously been unattainable. Centralizing the financial activity arms CROs and sponsors with the data and insight into patient engagement and retention for better planning and success in future studies.An automated reimbursement solution – for all clinical research, Phase IV or otherwise, can bring a unique advantage to a study that is often overlooked. Increased site engagement, patient retention and financial control are extremely valuable and only a proven partner that is exclusively focused on clinical payment technology can deliver on the promise of this innovative approach.