Stacy Weil, Senior Vice President, Clinical Data Operations, Premier Research
Nicole Carswell, Executive Director, Patient Engagement and Recruitment, Premier Research
Patient centricity—also known as patient-centered care—has been a growing force across healthcare. Like the consumer-driven change in other industries, patient centricity upends established models. Whereas traditionally, healthcare professionals dictate care decisions with little consideration for the patient’s desires, patient-centric care puts the patient first. Its tenets include:
• Empowering patients through technology
• Reducing inconvenience
• Designing protocols with patient associations
• Always making patients feel valued
In 2020, when Covid-related patient-safety concerns accelerated demand for decentralized clinical trials (DCTs), investigators found a surprising side benefit: DCTs are inherently patient-centered.
Now patients themselves are driving the demand for DCTs, and DCTs are being shaped to reinforce patient centricity further.
DCTs: The Shape of the Modern Clinical Trial
For over a decade, growing reliance on technology to manage disparate aspects of clinical trials has created an analogous growth in freedom from trial sites. Various e-tools have been incorporated for the convenience of sponsors and investigators. Electronic health records and eConsent forms can be accessed by staff anywhere. Centralized systems simplify data aggregation, monitoring, and analytics. Whether from ePro devices, wearables, or home testing, real-world information has opened rich new data streams while reducing overall trial costs. Still, uptake in the historically risk-averse healthcare industry was slow until COVID-19 forced broad-based changes in clinical trial deployment.
Over the past two years, the industry has become more comfortable and increasingly accepting of DCTs (also known as hybrid or remote trials). Many seemingly insurmountable hurdles have proven not to be that daunting after all. Moreover, there are unexpected benefits:
• Patient recruitment is simplified
• Retention is easier
• The data are better
All this combines to raise the caliber of the trial.
Now, there is no going back. In July 2021, the Industry Standard Research (ISR) Report on Hybrid/Decentralized Clinical Trials Market Outlook surveyed global industry leaders who had been involved in DCTs over the past year; 83 percent predict that within three years hybrid models will be used more often than traditional models. That is good news for patients.
For Patients, DCTs Deliver Hope From the Comfort of Their Homes
Patients in clinical trials—and their caregivers—have one overriding pain point: travelling to a designated clinical trial site. At best, such travel is time-consuming and tedious. Patients may live two or more hours from a trial site; every appointment becomes an all-day venture. Patients with mobility issues and those who rely on public transportation have added challenges. Hourly employees don’t get paid leave from work, adding lost income to the equation. Parents may face childcare dilemmas. In a patient-centric world, bringing the trial to the patient is a game-changer. It also opens the opportunity to participate in trials—and the hope they bring—to a vastly broader patient population.
Of course, some clinic visits may still be necessary; for instance, oncology trials often require infusions. However, most data collection can be accomplished through wearables and other mHealth devices, augmented by mHealth strategies that alleviate the burden of traveling to a trial site for every visit. More complex procedures can be conducted in the patient’s home, school, or work by trained healthcare providers who operate as an extension of the research site staff. And hospital-based procedures may be handled by a local or mobile clinic instead of a centralized trial site.
Patients who have participated in DCTs now recognize that this model is possible, setting expectations for the future.
For Sponsors, DCTs Solve Seemingly Intractable Problems
By addressing patient needs, sponsors have found they are solving many of their longstanding challenges: recruitment, retention, diversity, and data quality.
Traditional site-based trials rely on patients from a set geography or patients’ ability to come to the site for long stretches. Both scenarios limit the enrollment pool, exacerbating recruitment challenges while also building homogeneity since sites repeatedly turn to the same patient population.
As previously discussed, the reduced time- and cost-demands of DCTs attract patients. In addition, their relative lack of geographic constraints, augmented by clever use of social media, has enabled sponsors to reach a wider potential patient population.
DCTs also help bolster diversity. Site visits put trial participation out of reach for many patients with access or transportation challenges. As a result, sometimes populations with a larger percentage of disease burden have been grossly underrepresented in a study, and dangerous safety concerns were never uncovered. DCTs help level the playing field for patients, making trial participation a possibility for all.
Still, the holy grail of a successful trial is quality data. DCTs deliver there, too.
• Attracting a diverse patient population that produces richer, more diverse study data
• Collecting unfiltered real-world data and other non-traditional data points
• Minimizing manual data entry, and thus keying errors
• Accessing data in real time versus waiting for weekly reports
Sponsors have every reason to embrace DCTs and continue to burnish their appeal for patients.
Simple Strategies to Maximize Patient Centricity
While DCTs are patient-centric by their very nature, sponsors and contract research organizations (CROs) will be well-served to consciously advance patient-centered initiatives as they continue to hone their DCT strategies. One simple approach: Following the tenets of patient centricity.
Reduce inconvenience
The simple lack of travel already drastically reduces inconvenience, but the technology requirements themselves could prove daunting for many patients. When designing the study, remember:
• Give patients the power of choice. If possible, give them an option to come into the clinic or have visits via text or telehealth.
• One size does not fit all. Technology choices must consider the target patient population, including mobility, tech prowess, fears, access to treatment centers, and other mitigating medical conditions.
• Manually delivering daily data reports is a nuisance. Where possible, choose devices that automatically report results.
• In-person tests, scans, and treatments may not have to occur at a trial site; evaluate them to determine whether they can be conducted via home visits and/or local healthcare providers. This eliminates or minimizes travel burden while infusing a valuable degree of personal interaction.
Empower Patients Through Technology
In addition to the mHealth devices that are a cornerstone of DCT data collection, sponsors should be sure to provide:
• Access to web portals for tracking appointments and study progress.
• Automatic reminders, notifications, and patient education— whether information on the disease, the study, or the technology—can make patients feel like an empowered partner in a study rather than simply a research subject.
• Access to lab results, trial data, and other data generated throughout the trial. Multiple surveys show that patients want access to their healthcare data. That includes study data, something that has traditionally not happened. The technologies harnessed for remote data collection and monitoring can simplify data sharing with the patient just as it does with the investigators.
Design protocols in partnership with patient associations
By working directly with patients and family caregivers through the patient associations, sponsors can better understand patients' disease burden, treatment goals and needs. All of which are key to developing successful patient-centric strategies and improving access to more diverse patient populations. Even regulatory bodies, including the Food and Drug Administration and the European Medicines Agency, have increased their focus on incorporating the patient’s perspective into trial design. The advantages:
• Reduces barriers to participation and ensures that sponsors support patients in ways that make tangible differences.
• Creates a virtuous feedback cycle for use in trial design for similar conditions.
• Improved recruitment, helping sponsors engage the right patients by understanding their unmet needs, the impact of their disease, and their preferred treatment patterns.
Make patients feel valued
It’s human nature: personalized services bolster engagement. This is one area that is not inherent in DCTs. Even in a fully remote trial, patients may need occasional support from a real human to help navigate technology, answer treatment questions, and offer reassurance.
• Choose technology the patient already understands. Most patients are accustomed to phone apps; few will be comfortable placing electrodes.
• Be proactive: Anticipate patient’s questions and concerns and address them in patient-facing materials.
• Speak the patients’ language. Offer clear explanations of everything from trial goals to measurement interpretation, consciously eliminating complex medical terms.
• Offer support. At Premier Research, we use Digital Navigators who understand the trial process and the technologies. They provide both training and ongoing support for patients and trial teams.
• Consider making patient-centricity a measure of trial success.
A Rare Opportunity to Transform the Patient-Sponsor Relationship
Thrust to the forefront of the healthcare industry’s consciousness, DCTs have almost magically transformed clinical trials. They have significantly improved patient access to studies by removing convenience, economics, and geography barriers to participation, thus helping ease enrollment and diversify representative patient populations. This expanded participant base, combined with the rich trove of real-time data produced by wearables, have boosted overall data quality. That, in turn, has improved the quality of trials.
Now, sponsors and CROs are incentivized to maximize every aspect of patient centricity in DCTs. In the process, they may make patients not just their partners but their staunchest advocates in the advancement of clinical research.
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