It goes without saying that patient participants are a crucial ingredient in the clinical trial recipe. However, as one research services professional advises, the huge importance of patients in studies and recognizing their value doesn’t always make it into the mix.
Outsourcing-Pharma recently spoke with Zach Hales (ZH), ClinCard product manager at Greenphire, about the importance of valuing patients, and how to break barriers in patient recruitment and engagement efforts.
OSP: How have clinical trials’ attitudes toward the role of a patient evolved in recent years?
ZH: Sponsors, CROs and the industry as a whole have been moving towards a more participant-centric clinical trial model. With a better understanding of the participant burden, we are seeing things like lost wages, childcare, transportation, etc. being considered when designing a study and assessing the barriers to participation.
OSP: What are some of the challenges studies have had in terms of reaching, recruiting, engaging and retaining patients?
ZH: In terms of reaching and recruiting participants, awareness remains a key challenge, as much of the population is still uninformed about what clinical trials entail and how to locate them. As for engagement and retention, access to trial/clinical sites can be a major barrier for participants, including lack of transportation, out-of-pocket expenses and time associated with participation.
Additionally, language barriers can contribute to participant enrollment. Is the participant comfortable taking part in a study where they cannot relate to the professionals and/or service providers supporting them? Do they not feel comfortable because the people they talk to do not look like themselves? While steps are being taken to enhance the participant experience, there is still room for improvement and growth.
OSP: What tools and techniques have trial teams used to help overcome some of these challenges, and how effective have they been?
ZH: As noted above, while many of these challenges remain, there are steps being taken to alleviate the burdens faced by clinical trial participants. As such, trial teams have been adopting new patient-focused technologies and services.
Some of these offerings include payment/reimbursement automation, real-time messaging and engagement platforms, e-diaries, global travel arrangement services and more. These solutions have proven to boost engagement, on occasions resulting in a 10-20% increase in retention and continue to evolve to further enhance the participant experience.
OSP: Where are trials still falling short, when it comes to patient engagement and service?
ZH: Diversity is a key topic within clinical trials as of late and for good reason. The lack in diversity has been identified as an area necessitating improvement with many populations (e.g., race, genetic, age, gender) being grossly underrepresented in clinical studies.
The positive take away is that we are talking about this today and sponsors, CROs, tech providers as well as other stakeholders from around the industry are coming together to make increased diversity a top initiative.
In addition to increasing diversity in clinical trials, we must also be mindful to being inclusive once study participants have enrolled. For example, improvements can be made in divulging study progress to its participants. This practice would help to ensure that participants feel like a valued member in the clinical trial process and may have a positive impact on engagement and retention.
This sentiment of valuing participants’ involvement is often exactly what’s missing in clinical trials today; the evolution is happening now, and sponsors and CROs are beginning to tailor their protocols to their targeted populations. The industry has begun to include participant feedback by to ensure that the study can meet their needs and to ensure that they have advocates and support throughout their clinical trial journey.
OSP: Why is it important for trials to work toward engaging patients more effectively, and treating them as partners?
ZH: It’s simple: if you don’t keep participants engaged, they will drop out. The downstream impact is hindered progress of the trial and a delay in getting critical drugs to market.
Providing a better participant experience through the aforementioned tools and services is even more vital today as protocols continue to increase in complexity and often require more out of the participants.
OSP: How has COVID-19 impacted trials and patient engagement?
ZH: Clinical trials, like many other industries, hit a roadblock, or at least a major speed bump – enrollment was slowed if not stopped and overall study progress was impacted. As studies slowly picked back up, there became a much greater focus on flexibility of care. In many cases this included executing and supporting decentralized trial methods (e.g., utilizing local labs, telemedicine, mobile and virtual technologies) in an effort to continue providing care while maintaining social distance.
OSP: Could you please talk about some of the ways Greenphire helps trial teams better engage and serve patients?
ZH: With the trend of increased protocol complexity, trials often require participants to travel further distances, complete more visits and with longer stays. Greenphire is directly addressing the burdens felt by participants by offering solutions and services that remove the logistical and financial barriers to study participation - from real-time payment and reimbursement (including data-triggered payments to support e-diary completion) to global travel services encompassing air, car services and rideshare, train, hotels, local language support and additional specialty offerings such as ambulatory care, visa services and more.
Greenphire’s goal is to eliminate out-of-pocket costs where possible, ensure timely and flexible reimbursement where necessary and ultimately deliver a stress-free clinical trial experience for participants.
OSP: Do you have any plans for future services or features you can tell us about?
ZH: Greenphire is continuously expanding upon our solutions suite, working closely with stakeholders from throughout the industry to develop capabilities that will meet the growing needs of the market. Some items that we are working on include virtual cards/mobile wallet for added payment/reimbursement flexibility as well as continuing our expansion of payment and travel capabilities into local markets world-wide.
OSP: Do you have anything to add?
ZH: Historically, the clinical research industry has been slow to adopt change (e.g., new technologies, processes, mindsets). With the current clinical trial landscape, people are taking a hard look at the way things have been done in the past and are now quickly adopting new methodologies to ensure clinical trials can not only continue but continue efficiently while maintaining safety for sites and participants, quality of data and a positive experience for all stakeholders.