Clinical trials were designed to assess the safety and efficacy of new medicines and medical devices. But researchers and patients have noted a positive side effect for decades: improved healthcare delivery.

For many patients, joining a clinical trial offers enhanced medical care and treatment, known as clinical research as a care option (CRAACO). This is because clinical trials are resourced differently than the average clinic or community hospital, providing a more robust network of caregivers, clinical technology and support to address individual patient needs.

For those experiencing rare or complex diseases for which there are few or no treatment options, CRAACO may be one of the only paths to improve their condition or extend their lives. We also know that when patients are offered research options, it translates to greater confidence and hope, as well as improved health outcomes, all while accelerating medical research.

The paradigm shift to more patient-centric, technology-enabled decentralized clinical trials (DCTs) during the Covid-19 pandemic also generated an opportunity to strengthen patient care during clinical trials. By strategically selecting and deploying technology products designed to improve the patient experience, researchers can deliver greater value to participants by creating more patient-caregiver touchpoints digitally while reducing the number of in-clinic visits and minimizing overall disruption to their daily life.

CRAACO’s translation to hybrid environments

DCTs became necessary during the pandemic to maintain patient and provider safety while ensuring critical clinical research continued during lockdowns. That experience proved that DCTs bring powerful new value to everyone involved—most importantly, to patients who benefited from more flexible trial engagement options supported by technology solutions.

The use of electronic consent (eConsent) products, telehealth services, direct-to-patient shipment of medication, electronic clinical outcomes assessments (eCOA), and other decentralized operational technology solutions allowed sponsors to enhance the patient experience while expanding their geographic reach. For patients, that now means their ZIP code is no longer a primary barrier to research participation by making their home a center for healthcare delivery and data collection during the trial.

When paired with the new DCT model, CRAACO has an enormous impact on people’s lives—as it gives more patients access to research participation when other existing interventions are not working. Individuals can receive a superior level of care, as their physicians are able to connect with them at a much more frequent cadence in comparison to a traditional trial model when communication is limited to site visits.

In DCT environments, patients may be asked to complete more regular tasks than in a traditional site-based trial, such as inputting biometrics or completing diaries. However, many perceive that as an improvement from a traditional model that would require regular time-consuming in-person visits at a hospital site—sometimes an hour or more away from their home. For this reason, DCT study teams are resourced to offer patients 24/7 support through chat functions or call centers.

With more trial data flowing directly and regularly into the study database, this model also supports improved safety as risk signals are detected in real-time compared to a traditional model where health metrics and study data are only gathered during on-site visits.

Trial execution: the use of digital tools for better patient care

The goal of clinical operations leaders today is to lower the burden of participation while creating highly engaging, patient-centric trial experiences that ultimately accelerate actionable insights and deliver new medicines and devices to market faster. Enter clinical technology solutions.

Our industry experienced a rapid increase in deploying products such as eConsent, wearable devices, eCOA, telehealth and chat support, all of which are implemented to improve patient outcomes during trials. Here’s some more insight into how some of these tools operate and benefit patients:

• eCOA: eCOA platforms intelligently automate and capture a patient’s experiences through robust and reliable electronic measures. The use of such technology provides real-time insights that inform trial progress and demonstrate results. This results in increased patient engagement, inherently improving care.
• eConsent: Several years ago, the first step in a clinical trial was receiving an Informed Consent Form (ICF), which was long, complex and made it difficult for patients to understand what they were signing up for—making clinical trials scary for many. These days, eConsent makes it easier for patients to understand what’s involved in a clinical trial, highlighting the pros and cons with multimedia learning tools that better support patients through the consenting process—resulting in increased retention.
• Connected devices: As telehealth becomes prominent, connected digital medical devices play a more critical role by reducing the burden on patients. For example, health data can be collected using an Apple Watch or other actigraphy device and fed into the central data repository of a trial, reducing the number of in-person patient assessments at a site and making the site visit shorter for the patient. Connected devices accelerate trial outcomes by streamlining the selection and deployment of medical devices to collect and analyze data.

A new era of healthcare 

The Covid-19 pandemic increased our global population’s understanding and awareness of clinical trials. We’re also learning that it had a positive effect on improving the perception and interest in clinical trial participation.

This openness presents an exciting opportunity for the biopharma industry to engage with patient communities and accelerate research. But in order to capitalize on this opportunity for greater engagement, we as an industry must consider the patient experience—their burden of participation and their health outcomes—at every decision point. Technology-enabled trials must become a permanent part of clinical research as they promote efficiency, speed, scale—and care delivery.

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