Going siteless can lead to clinical trial troubles: AiCure

By Jenni Spinner

- Last updated on GMT

(Drazen Zigic/iStock via Getty Images Plus)
(Drazen Zigic/iStock via Getty Images Plus)

Related tags Decentralized trials Virtual clinical trials Patient centricity patient engagement Research Remote clinical trials

A leader from the clinical trial solutions firm talks about the drive toward conducting trials without sites, and why that idea might lead to problems.

While clinical research increasingly adopts decentralized trial models, many professionals in the industry wonder if sites are needed at all. Ed Ikeguchi (EI), CEO of AiCure, discussed with Outsourcing-Pharma (OSP) discusses the important role a site can play, as well as some of the problems associated with fully decentralized studies.

OSP: Could you please share your overview of how decentralized trial technology has evolved in recent years?

EI: Traditional clinical trials, which rely on in-person visits and subjective measurements of a patient’s compliance and response to treatment, can be extremely costly, lengthy, and may lead to incomplete or inaccurate data because patients can only be seen at sporadic intervals. Deploying trials virtually not only helps to reduce some of the burden of in-person visits and costs, but also helps enhance the integrity of trial data.

More and more, the industry is realizing the value of achieving a deeper understanding of patient behavior outside of the clinic – from whether they took their medications, to monitoring for subtle symptom cues that could be missed during in-person visits. In the last decade or so, pharmaceutical companies have gradually incorporated digital health approaches to support specific aspects of their studies; these technologies include virtual enrollment and consenting solutions, applications via patients’ smartphones to gather dosing data, remote monitoring tools to measure a patient’s response to treatment, wearable devices and electronic diaries, and more.

In the face of COVID-19, many sponsors and study teams have modernized their approaches out of need, incorporating digital tools to help recruit the right participants, monitor and engage with them remotely, and analyze data using artificial intelligence. With advancements in technology and interest in virtual trials greater than ever before, many in the industry are increasingly willing to deploy remote tactics to safeguard business continuity.

OSP: How did the concept of virtual trials come about?

EI: With the advancement of decentralized trials and surges in innovative remote monitoring tools, companies began to imagine a future where visits to brick-and-mortar clinics can be reduced, or even eliminated entirely. Virtual trials bring the clinical trial experience directly to a patient with all medications and equipment needed delivered to them. virtual models often deploy layers of various technologies to remotely aggregate and transmit patient data – from electronic consent platforms, wearables and connected devices to measure patient response, to videoconferencing solutions for pharmacists or contracted nurses to provide support as needed.

OSP: Please explain what the reasons are why a virtual trial might be appealing.

EI: Virtual trials offer patients a convenient way to participate in a clinical trial, eliminating the need to travel regularly to the site for in-person evaluations and allowing them to set their own schedules, which works well for patients whose illness causes them to be homebound, or for those who live in rural areas or far away from the site. For sponsors, it offers a larger geographic reach and a more diverse patient population to recruit from. By removing the need for multiple physical sites and their staff, it also is a cost saver.

While this all sounds appealing in theory, saving cost and improving convenience should not be the primary goals of any study – the aim is to conduct high quality trials to create high quality drugs built on sound data.

Modern telecom tools and the ubiquity of smartphones has enabled the advancement of telemedicine in society, further supporting quality delivery of healthcare in a remote setting. Especially with COVID-19 and considerations around social distancing, many patients have been reluctant to expose themselves by committing to multiple in-person visits to doctor’s offices.

OSP: Could you please share how the reality of virtual trials varies from the theory? What are some of the key problems?

EI: An often overlooked but critical component to a study’s success is the clinical trial sites themselves. While technology has certainly come a long way, the personal relationship between a patient and their site-based caregiver is an essential piece of the puzzle that can’t be replicated.

The nurses or pharmacists employed by a siteless virtual trial have no relationship with the patient, and therefore, the patient has less affinity to them or to the mission of the trial. Having a physician involved in any type of patient care is critical, but it is a nonnegotiable in a clinical trial setting when there is a certain level of patient apprehension or anxiety – whether it’s about their illness or the drug they’re taking.

It is easy to imagine that it may feel impersonal or intrusively “big-brother”-like when the CRO or a contracted nurse reaches out to a patient to ask why they didn’t take their medication last night. It is not only more effective to have their physician intervene, but it can also improve long-term patient engagement by getting to the bottom of any obstacles the patient is facing and offering personalized support.

Beyond the loss of this relationship-building aspect, there is also a data quality concern. Many siteless virtual trial solutions cobble together monitoring technologies that may seem integrated in one cohesive platform, but it doesn’t always function that way; many of these devices measure biometric data very differently and are not built to work together, leading to various process redundancy and data quality issues.

To support the move to virtual clinical trials, and the variety and volume of patient data that comes with it, there needs to be a standard across these systems or a single platform where the data can be collected, harmonized, and analyzed quickly and efficiently.

OSP: What are your recommendations for dialing back from the siteless model?

Ed Ikeguchi, CEO, AiCure

EI: Clinical trials need to maintain the humane, personal touch that comes from site involvement. Monitoring and patient engagement technology can provide extraordinary value, but the key is for this technology to augment the role of the site provider – many of whom have spent their entire professional life devoted to building quality clinical studies – and not to serve as a substitute.

From the beginning, establishing a foundational relationship between the patient and clinical study team can pay off during the trial, creating open and honest lines of communication about how a patient is feeling. At the onset of a study, a care team can explain the logistics of the trial in detail while also getting a sense of whether the patient truly understands what is expected of them and the level of support they might need.

Making a point to begin patient engagement in-person or via videoconference helps to solidify the personal connections between patients and clinicians. Once this happens, employing virtual trial technologies, such as digital biomarkers or dosing support, can complement the work being done by the care team and provide real-time data and advanced visibility into a patient’s response to treatment.

When it comes time for a check-in, providers don’t need to spend the time getting up to speed about a patient’s experience or recording data, but can instead focus on strengthening the relationship, keeping patients engaged and improving retention. With this amount of data at their fingertips, clinicians can focus their attention and support where it is needed most to optimize these interactions.

OSP: Connected to that, please talk about the benefits of making the site a trial hub, instead of going siteless.

EI: When you lose the patient-provider relationship, the patient’s engagement in the trial, and consequentially the trial itself, suffers. At the end of the day, value comes when sites engage with patients in their real-world environment and understand their lived experience.

For studies to be successful, patients need to trust their care providers as their support system, and study teams need to understand the levels of intervention each patient needs to stay on track. While monitoring technology can be useful in collecting and analyzing study data, tech-savvy sites are the key to unlocking their true potential by using these tools to strengthen patient relationships.

OSP: What are the benefits of harnessing technology for patient engagement?

EI: Patient engagement and the deployment of remote clinical trials all comes down to how much virtual connection can you have with a patient – whether its in the form of telemedicine and understanding why they didn’t take their medications on time, or giving doctors the power of constant oversight to understand even subtle changes in a patient’s condition to inform timely interventions. This is the level of granularity that is necessary for a site to run a high-quality trial.

At the same time, giving patients a tool that lessens their burden will help keep them active and involved. Technology that helps simplify what can be complicated treatment regimens as well as activating an always-open communication channel to the site team can make a big difference in patient engagement.

OSP: Please tell us about clinical care giving new drugs an edge.

EI: Doctors are pharma’s ultimate clients during late-stage studies; this is when companies often identify their top prescribers for real-world patients once the drug is approved. Siteless models can send a bad message to this future customer base by taking away a major source of their revenue stream, leading to the neglect of potential sellers. Furthermore, with the help of the site team, the right virtual trial tools can build a data-driven case for a drug in a competitive market.

New drugs are rarely orphans in their category, so pharma companies need that extra edge over what the incumbent is not doing. Depending on the drug, behavioral patient data can be a valuable proof point for commercialization. Specific behavioral benefits that can’t be extracted from traditional clinical trial end points or siteless virtual models, but only with a combination of technology and physician involvement, can help them be competitive.

OSP: Is there anything else you’d like to add?

EI: With the recent surge in remote clinical trials that helped many pharma companies keep the lights on during the pandemic, the industry is at a pivotal moment of defining what the optimal model looks like. Healthcare/pharma technology is a crowded, noisy space with each new innovation claiming to be the next solve-all or promising to make things faster, cheaper or more accessible.

While there is a lot of technology to be hopeful about, we can’t neglect the heart of patient care – the relationship between a provider and a patient. There’s a balance to be achieved between making drug development less costly, burdensome and wasteful, while also recognizing the role these key stakeholders have in maintaining quality and ensuring patients stay engaged during what can be a long and emotionally challenging trial.

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