Patient-Centric Clinical Trials: The Power of Choice

It is estimated that only three percent of U.S. physicians and patients take part in clinical trials that lead to new therapies. Although the challenges of patient enrollment and retention have impacted studies for well over a decade, digital advances could potentially reverse this trend by encouraging patient engagement and reducing drop-out rates.

“Patients overloaded with too many tasks are more likely to abandon the trial,” observes Tim Davis, vice president of strategy for MyVeeva for Patients, who discussed expanding patient choice in a recent podcast. “For instance, a patient grappling with a medical condition may not want to receive multiple notifications and use an ePRO diary while also syncing wearable data to an app every day.”

The site experience could be undermined for similar reasons. For example, a sponsor may use distinct systems for eConsent, electronic Patient Reported Outcomes (ePRO), and televisits, as well as unique electronic data capture (EDC) and clinical trial management software (CTMS) platforms. Inadvertently, this approach increases the workload for sites. If data from these systems aren’t integrated, sites have to manually enter metadata (e.g., a patient’s ID, a visit schedule), in addition to other patient data.

Before adding to a collection of disconnected clinical trial systems, it’s worth considering whether new technology will expand patient choice — or lower the burden on sites responsible for delivering high-quality care. The greater the reliance on manual data entry, the higher the risk of error. Even worse, disconnected data and manual processes can trigger delays in data availability once the study is complete.

Why we need to expand patient choice

The FDA and other regulatory bodies encourage patient-centric drug development. Patient centricity involves positive, sustained engagement to achieve the best possible patient experience and outcome.

“Patient centricity can be summarized in one word — ‘choice’,” says Davis. “It’s giving options to a patient. It’s making the trial as convenient and as comfortable as we can.”

Patients volunteer their time and energy to trials with no guarantee of clinical benefit. Successful clinical research hinges on their participation and their voice. Giving patients choice benefits all stakeholders for several reasons:

• Respect patients’ individual needs. Each patient has unique preferences and priorities. “If we’re asking people to participate in research, it seems only right that we should offer choices that align with their priorities,” points out Davis.
• Encourage participation. Inconvenience is one of the top reasons why patients drop out of studies. If patients feel like they have control over how they participate in clinical research, they’re more likely to stay engaged in the process and participate until the end of the trial. Giving patients the choice of participating on site or remotely could help sponsors improve patient retention.
• Promote clinical trial diversity. The FDA will soon require companies seeking approval for new drugs to submit a diversity plan for study enrollment to increase the number of trial participants from under-represented groups¹. By expanding choice, sponsors open the door to a broader mix of patients. “If you have a one-size-fits-all approach to clinical trials, you may exclude populations who might otherwise be interested in participating, but who have different preferences to what you’re offering,” notes Davis.
• Collect higher-quality data. If patients are comfortable with the device controls and operating system (for example, because they are using their own device), they will find it easier to complete ePRO. Conversely, a poor user experience increases the chance of errors or missing data points. “If you have people who are more engaged and more enthusiastic about participating, they’re more likely to stick with the trial, to adhere to the protocol, and to provide accurate data,” adds Davis.

How can sponsors expand patient choice?

Remote participation enables sponsors to recruit patients from a wider geographic area, as well as accommodate patients who may not be able to travel to a site. By the same token, allowing patients to choose between getting tests done at a local lab or the research site increases patient choice. Other ways include:

1. Begin with the end in mind. When designing patient-centric digital trials, consider the perspective of the end user. How and when will patients engage with an ePRO app? Can they easily find the FAQ section? Can they access a plain-language summary of clinical trial requirements?
2. Consider a BYOD approach. While provisioned devices have their place, patients may prefer to use the mobile device they already know how to use. “We don’t need to force devices on people who probably have a better device in their pocket anyway,” argues Davis. Working on a familiar interface makes it easier for patients to navigate apps and complete assessments, lowering the risk of noncompliance.
3. Simplify study participation. When implementing a single, easy-to-use application, aim to give patients all the information they need in one place. Celerion, a contract research organization (CRO) based in Lincoln, Nebraska, used Veeva eConsent for their Phase 1 studies. Patients accessed consent documents through MyVeeva for Patients, an app where patients can view all their study activities and documents.
4. Review patient feedback. For instance, Celerion found that while patients appreciated a paperless process, they placed an even higher value on an easily accessible study schedule and phone numbers for the nurse’s line or their study coordinator. By providing easy access to key study contacts via the app, Celerion reduced call center activity by nearly 25%.

Reducing the clinical trial site burden

Sponsors and CROs value speed — real-time data availability, faster study builds, faster time to database lock. While many clinical technology solutions offer efficient ways to design and execute studies, using a disparate collection of tools puts an avoidable burden on sites and undermines the patient experience. A few starting points include:

• Standardize processes and workflows to create a repeatable model that is applicable across most studies. Although minor customization will be needed for each trial, a standardized process will lower complexity and enhance usability.
• De-risk the trial by lowering the site burden. Disparate, siloed systems make it more difficult to manage studies and monitor data across the clinical trial lifecycle. The additional training and time required to manage multiple systems also strain site resources. If a protocol involves too many systems and software, sites may either resort to paper processes to meet deadlines or opt not to participate in a study.
• Enlist a unified suite of solutions. A free-to-site platform eliminates the need to manage data across multiple standalone systems. Free from the burden of learning how to use more software, sites have more time to focus on their patients.

Platform for patient-centric trials

Delivering patient-centric trials requires careful consideration of the security, compliance, and data management features that matter for your organization. It’s also important to evaluate the impact on sites and patients. This includes the ease of an end-to-end system and its adaptability to the needs of your trial, regardless of how and where it takes place.

“There’s a case for doing things remotely, there’s a case for things in person, and there’s a case for a mix of both,” concludes Davis. “To be truly patient-centric, we have to offer a mix of solutions depending on where patients live, how unwell they are, and where they are in the trial journey. The platform needs to flex to all those situations.”

Listen to the State of Digital Clinical Trials podcast to learn more about patient-centric trials.