When thinking of clinical trials and the concept of patient convenience, one must consider the increasing complexity of protocols and how much is being asked of patients that are enrolled. Strict inclusion criteria results in increased scrutiny to find the right patient, and keep that patient enrolled in the study. In rare disease and immunoncology, for example, ideal study participant candidates often live hundreds of miles or more away from the research site which increases the challenges of enrolling and retaining those participants. Study sponsors and CROs are instituting programs to remove financial and logistical burdens to ensure that these participants remain in the study for the duration, so they don’t have to find yet another “needle in a haystack.”
But what about vaccine clinical trials? Vaccine trials in general turn this concept upside down. Instead of looking for a rare patient, researchers are looking for healthy volunteers – and large volumes of them. To bring urgent treatments to the masses, retaining every single participant to ensure that clinical trial data is compliant is paramount.
With COVID-19 dominating the headlines, many study sponsors and CROs have turned to Greenphire to help with initiating patient and site-centric technology solutions for their clinical trials in 2020. In this short blog, I’d like to share with you some of the insights we’ve gleaned from working with top sponsors, CROs and sites on COVID-19 and other vaccine studies. These may be helpful as you plan for 2021.
@Issue: Missing Data, Extended Timelines, Delayed Drug Delivery
Let’s start with an example from our recent experience with a COVID-19 vaccine study. Upon being successfully screened, the study participant is vaccinated twice. It is critical for these participants to be present for the second vaccination. Once successfully vaccinated, participants are asked to complete a weekly eDiary to identify side effects and/or adverse events. But what happens if the individual misses the second visit? Or doesn’t complete their necessary e-diaries?
Missed visits and incomplete ePRO e-diaries result in inadequate data, data needed by sponsors and CROs to remain compliant and determine if novel treatments are working.
That’s where Greenphire comes in.
Added convenience through a hybrid approach
Protocols today have been amended to meet the current COVID-19 environment, but also today’s more digital-savvy patient.
Let’s revisit our example above and start from the individual being entered into the study. How can we improve the experience for patients, as well as sites?
1 – Remove transportation barriers: Instead of leaving it up to the participant to find a way to the clinic – public transportation, a friend or family member which could either be unsafe or unreliable, you can provide a ride to the clinic. Greenphire’s ClinCard integrates directly with Lyft to make it easy for study coordinators and obstacle-free for participants. For longer-distance travel, ConneX can arrange for study travel via car service, train, plane and more. These transportation services can also be used to get patients to local labs, instead of mandating that visits such as blood draws take place in the clinic. With solutions like these, access is no longer a barrier to participation.
2 – Valuing the participant for their time and inconvenience: It’s not enough to say that you’re patient-centric, you have to show it. In addition to removing the travel obstacles, sites, sponsors and CROs around the globe have initiated ClinCard to automate global patient reimbursement. Our solution is available through flexible payment methods such as a reloadable debit card, direct deposit or our forthcoming virtual card. In many instances, patients take time off of work to participate in a research study. It’s not enough just to offer the medicine or treatment for participation; providing a small stipend or reimbursement is now commonplace and accepted to acknowledge the sacrifice of patients.
3 – Ensuring eDiary compliance: To engage patients at home and in real time, sponsors and CROs have initiated eCOA/ePRO solutions. While these are excellent, experience has shown that at-home distractions may cause a participant to slip in recording their daily or weekly symptoms on time. Our ClinCard solution can integrate with many of the leading eCOA/ePRO solutions (such as ERT and Signant Health, to name a few) to trigger a small “micropayment” to the participant. In these instances, your participants don’t have to be in the clinic to complete an activity and they are still being compensated for their time.
Let Greenphire help
Today’s sites, sponsors and CROs are looking for ways to improve the patient experience and drive protocol compliance. Their feedback and our insight into leading fintech trends have fueled enhancements that help to remove all patient experience blockers.
When it’s mission critical to ensure that each and every participant stays enrolled and engaged, turn to Greenphire to modernize the experience through a hybrid approach.
We can help you with:
- Getting up and running – fast. Our expert implementation team will have our solutions configured to your study needs and up and running within a matter of a few weeks,.
- Serving up scale. Greenphire’s ClinCard (reimbursement/stipends), ConneX (travel) and eClinicalGPS (site payments) are flexible and scalable to meet the global challenges of vaccine trials.
- Delivering a best practice approach. Given that Greenphire has worked with the leading researchers and institutions – both for COVID-19 and otherwise, we can provide both the experience and intelligence for how you should consider implementing a patient and site-focused engagement program. We have seen firsthand what works – and more importantly, what doesn’t. We have a robust relationship management and training team to support your study launch and execution.
I invite you to learn more about our entire suite of solutions for clinical trial automation, or contact us today to get a demo. From all of us at Greenphire, we hope that each of you are safe and healthy.
