May 13, 2024 Source: drugdu 110
Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget.
By Tanya Kogan on May 10, 2024
Clinical trials today require more patient involvement than ever before. Yet longer, more frequent site visits or participation that requires extensive travel can impact a patient’s willingness to participate in and remain in a clinical trial over the long term. As a result, patient recruitment and retention can be a challenge for sites and pharmaceutical companies, especially when the target patient population is small or geographically dispersed. Sadly, the average dropout rate across clinical trials is 30 percent.
With the increasing need for consistent and accurate patient data, sponsors and sites are investing in electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) systems that allow clinical trial participants to remain at home and share their information digitally. I’ve spent the last 15 years conceptualizing and launching technologies that solve problems, enhance efficiency and data accuracy, and have witnessed how these systems have become essential to participant engagement and retention and thus, the overall success of trials. Sponsors and sites can collect valuable data and ask key questions of patients regarding the frequency and severity of their symptoms, such as “Do you feel better?'”or “Rank how you feel today versus yesterday”.
This type of technology investment increases patient convenience, decreases recall bias, and removes a layer of burden from the site and the patient. In addition to providing tremendous convenience to the patient, this type of system also eliminates paper diaries and reporting inaccuracies. Patients can click a few buttons and information about their symptoms or treatment and it is transferred and integrated with other research data in real time.
Yet, technology can still have its drawbacks. What if the patient forgets to enter information for a day? Or worse, what if the patient goes away for a few days and forgets to pack the device? How can technology help engage the patient for the long term?
Even with the best intentions, mistakes can happen, and diary compliance remains a challenge, whether using paper or digital methods. This is true particularly in large trials with thousands of participants where missing diary entries and inputs can greatly hinder a sponsor’s data analysis throughout the trial. ePRO and eCOA solutions present the opportunity to increase patient engagement and, therefore, increase data collection and compliance. However, these systems, although convenient, still require effort from the patient to complete the required diary entries.
Enter patient micropayments. Micropayments, a financial transaction involving a small sum of money, provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget.
1.What is a micropayment? A micropayment is a small payment to someone, often for a service. When a patient is required to complete an e-diary, it’s common for them to forget to complete all their required tests. When patients are incented through a micropayment, it not only allows a sponsor to thank patients for continuing to comply with, and complete, all of their required actions, it encourages and rewards them to continue to do so throughout the trial. Sponsors may think that this is cost-prohibitive, but it’s not: just a dollar or two can go a long way in keeping patients engaged and participating on a regular basis for the entirety of the trial.
2.Why this topic, right now? We’re at a tipping point in the clinical trial industry. Where there used to be resistance to patient payments, the FDA has recently clarified guidance around compensating patients for their time and expenses with regard to clinical trials. This is true even just this year with regard to diversity. New FDA guidance encourages sponsors to identify different ways, such as patient reimbursement, travel programs, and the use of technology, to encourage diverse populations to participate in clinical trials.
3.What do sponsors need to do in order to get to the next level with patients? Are you seeing more sponsors interested in technology such as micropayments? Yes! More and more sponsors are measuring the results of eClinical technology not just in hard costs (quicker completion of trials), but also in providing a better experience for patients and demonstrating empathy to their cause. Sponsors are rethinking the entire patient experience, from enrollment through completion to best meet patient and trial needs. In some cases, they’re reimbursing the patient’s entire travel experience. On the other hand, with eCOA/ePRO, a patient may not even need to leave the comfort of his or her own home. It all starts with trial design and reviewing overall trial protocols to ensure that they’re aligned with patient expectations. Sponsors are thinking about these necessary steps earlier in the process, and leveraging experts and patients to identify avoidable roadblocks.
4.How do micropayments affect sites? Micropayments are a cost-effective way to keep patients engaged and participating fully throughout the full course of a trial. When paired with eCOA/ePRO systems, micropayments can save site staff significant amounts of time in administrative work, as well as help to ensure trial success. With the availability of reloadable debit cards for trial participants, it’s quick and easy for sites to trigger a micropayment instantly when a task is completed.
As clinical trial sponsors and sites seek to maximize patient engagement and retention, and reduce drop out rates, they are turning to technology more and more. Micropayments will continue to play a critical role in helping to ensure participants who are digitally connected to a trial are fully engaged and feel rewarded for their efforts.
Photo: pictafolio, Getty Images
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