The continuum of the clinical trial participant experience

The continuum of the clinical trial participant experience

How technology integrations are fueling improved patient access beyond the research clinic

By Jim Murphy and Bill Byrom

Over the past decade, the clinical research industry has steadily adopted new digital technologies to streamline business processes and improve user experiences, realizing efficiencies and insights along the way.

This shift from manual processes, and paper and pencil data collection, to software solutions has been a cautious one. After all, digital transformation in such a highly regulated environment must be methodical. Yet, when the pandemic struck, the use of technology accelerated, and existing technology adapted, providing the opportunity to keep studies running and engage patients both in and out of the clinic.

With this experience in the rearview mirror, we have the opportunity to reimagine how we deliver clinical trials for today and tomorrow, building upon the progress and process improvements we’ve already made.

The industry must be strategic and bring together best-of-breed technology workflow solutions for the next generation of the participant experience. The following are some proven examples.

Key requirements for stakeholders

To ensure that studies are successful, sponsors must find solutions for collecting sufficient, quality data, while simultaneously ensuring that participants feel engaged.

The same dynamic applies to clinical trial sites.

As trials become more complex and participation options increase, sites need innovative and reliable technology to meet patients where they are. Staff should be well-equipped with tools that relieve them of administrative tasks, allowing them to focus on providing positive experiences for the patient wherever they are having their visit. After all, the doctor-patient relationship is one built on trust and critical to fostering a positive perception of the volunteer’s overall study participation.

Fundamentally, the FDA and other global regulators want to uphold the integrity of clinical data collection and ensure that assessments are done when they are supposed to be, not while a patient is sitting in a waiting room for a visit.

Let’s dive further into this dynamic and how technology is playing an emerging role. 

Successful solutions for virtual patient engagement

While in-clinic visits typically rely on technology for a component of data collection, remote trial activity relies exclusively on software and tools for data collection and video-enabled visits. This remote activity can often offer more flexibility for participants, but also the ability for the study sponsor and site to harvest more and richer data. There’s tremendous opportunity for real-time insight into patient experience, but also to transform the study volunteer’s relationship with the site itself.

Clinical trial solution providers, such as Greenphire and Signant Health, have worked on advancing integrated solutions to address the challenges posed by decentralized data collection and other required activities which are not carried out physically at clinical trial sites. Both organizations have successfully integrated on large-scale studies to simplify the participant experience and increase protocol compliance, all without creating additional work for site staff.

Let’s look at how this works.

A key patient interface for remote patient activity is their patient app. This enables the patient to self-report symptoms and quality-of-life data by completing various patient-reported outcome measures (PROMs) as required by the protocol. The app might also contain information to guide the patient through the trial, such as providing the time/date of the next on-site or video visit alongside information on what to expect and how to prepare. When an at-home PROM is completed, the data triggers a micropayment, which can be done in real time. It appears as one unified experience for the user, but behind the scenes, sophisticated solution providers securely transfer information across APIs to create a seamless participant experience. Ultimately, the payment helps to motivate the participant to continue with aspects of the study, such as filling out their diary daily, keeping them engaged in the study and reinforcing protocol compliance.

Establishing standards for integration and innovation

According to the Tufts Center for the Study of Drug Development, sponsors and CROs use double the number of technology applications as to what was used just 10 years ago. However, quantity doesn’t preempt quality. Sponsors should be confident knowing they are working with industry leaders that can provide effective and proven solutions that meet their trial goals at scale. Technology innovation, but also ease of integration are important considerations for sponsors in evaluating the maturity of vendor partners and their capabilities.  

A summer market trends survey conducted by Greenphire reinforced the importance of interoperability. 75% of sponsors and CROs agreed that their organizations prioritize working with solution providers who are experienced at integrating with other eClinical solutions and offer resources dedicated to facilitating the integration process.

Seamless integration helps to reduce day-to-day administrative burdens on sponsors, and creates the ability to realize ROI through efficiency, proficiency and transparency.

They should be assured that as trials continue to evolve, so will the innovation of the companies and products into which they’re buying. By choosing a provider that leads the way in keeping up with the industry evolutions and values data accuracy and safety, sponsors future-proof themselves through conducting successful trials that produce quality and accurate data.

The continued evolution of trial technology: How to capture quality and real-time data

Just as the science itself has evolved, the trials supporting them have advanced immensely as well. For example, patients used to have set periodic site appointments which only provided a snapshot of the patient’s health, and often relied on their memory from days, weeks, or months prior.

Now, instead of relying on patient memory and dispersed data points, technology enables sites to collect rich data from patients in real time, providing insights like never before.

Embracing technology has also enabled flexibility, opening the door for patients who previously would not have been able to participate if required to make regular site visits. Not only does this improve access for patients who want to help advance science, it also provides sites and sponsors with an opportunity to include a wider, more diverse set of participants.

Using technology, patients can interact with the study at a time that is convenient for them, ensuring that study participation can fit within the individual demands of busy lives and families. These tools not only collect data but facilitate participation by providing engaging resources and information about the trial, providing site- and video-visit schedules and reminders, and being the interface to other utilities such as telemedicine or connected devices. When participants have easy access to these types of tools, they are more likely to stay in the trial and continue to engage throughout the study – as exemplified in the use case discussed in this article.

While it’s clear that adding technology to enable remote and hybrid studies has its advantages, sites remain critical partners in clinical trials. So as sponsors continue to embrace these digital advances, it’s important for them to think ahead. How will payment technology integrate with eCOA technology? How will these solutions impact sites daily? What does that mean for the efficiency of our study? Will these solutions interconnect seamlessly with existing technologies and empower participants to stay enrolled?

There has never been a more exciting time to work in clinical trials, due in part to an increasing number of protocols which provide for participant flexibility and real time data collection outside of the site. Dynamic eClinical solutions can engage patients where they are, reduce burden on sites, and create visibility and predictability for sponsors. When considering tools and solution providers to empower your trials for what’s possible now and in the future, it only makes sense to add those that can work together to simplify and ultimately enhance the process for near term and whatever comes next.

About the authors
	Jim Murphy is CEO, Greenphire, leading the strategy for the company, including client satisfaction, business operations, commercial execution and financial performance. He has focused his career on building innovative eClinical software companies to address challenges and unmet needs within the global clinical research ecosystem. Prior to joining Greenphire, Murphy most recently served as the president and managing director of Almac Clinical Technologies, where he was responsible for strategic, financial and operational leadership. While at Almac, Jim also served as the president and managing director of Almac Pharmaceutical Services – Asia, where he established and managed the Almac Group’s Asia Pacific organizations and business operations across all solution areas. Murphy earned a Bachelor of Science in Biochemistry and a Master of Science in Molecular Biology from the University of California at Santa Barbara.  Greenphire provides financial and logistical solutions for clinical trials, and a best-of-breed solution for reimbursement and stipends, removing some of the most frequently reported burdens that often cause participants to drop out of a study and reinforcing protocol-critical activities.
	Bill Byrom, Ph.D. is the vice president of product intelligence and positioning, and principal eCOA Science at Signant Health where he also serves as a principal ePRO scientist. He has worked in the pharmaceutical industry for 30 years and is the author of over 70 publications and two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work includes the use of wearable technology and bring- your-own-device (BYOD) eCOA in clinical trials. Byrom recently served as Vice Director of the C-PATH ePRO Consortium, and is an active member of the DIA Study Endpoints Community where he leads a cross-disciplinary group on the use of endpoints derived from wearable devices to support labelling claims and regulatory decision making.  Signant provides evidence generation in clinical trials, and ePRO/eCOA solutions such as those collecting patient-reported outcomes or sensors and wearables so data is collected accurately and at the right time. In-built alarms, reminders and notifications aim to drive completion compliance, with remote oversight by the site and CRA.