COVID-19 shutdowns accelerated the need for life sciences companies to enable remote participation in clinical trials for patients and researchers. While technology can be a key enabler of these decentralized clinical trials (DCTs), so is a service-design mentality that reduces points of friction for all stakeholders so that they may humanize the DCT experience for increased patient recruitment, retention and trial efficiency.
To support a successful move from traditional, centralized clinical trials to DCTs that can work better for patients, investigators, sponsors and clinical research organizations (CROs), we share four recommendations.
Focus on patients — and details.
If a trial participant is uncomfortable, anxious, confused or inconvenienced by a DCT, they are more likely to drop out. Rather than adopting the latest technology for its own sake, DCT designers should focus on the needs of target patients when selecting technologies and tailoring the trial protocol, tools, processes, and even the language that they use with patients. To make the experience as easy as possible for participants, avoid frequent or overly complex at-home assessments, as well as technologies that might be difficult to use.
Success lies in knowing the target population well enough to anticipate and prevent problems as well as how to best support them when needs arise. Some key questions to ask: Do they speak English or rely on a caregiver to translate? If their wearable loses connectivity with their home WiFi network, will they be able to describe the problem to a help desk? Will the battery in their wearable sensor run down so quickly that they’ll forget to recharge it or feel it’s a nuisance?
Also, be sure to account for their emotional needs. If a patient is being treated for a life-threatening or terminal disease, can loneliness, depression or discouragement be sensed through voice recognition, a lack of movement or other cues? How might they receive comfort, encouragement, or just a caring ear, and can these interventions be supported through digital devices, social media or online communities? An ethnographic or anthropologic study of potential participants can help trial designers envision the experience through their eyes, eliminating or minimizing points of friction.
This holistic, empathetic view of the patient’s overall experience should extend to the language used, such as referring to them as “patients” or even “clients” rather than “subjects,” and ensuring that the provided information is understandable. All of this not only maximizes retention but also improves the experience for all stakeholders who can play a more human, caring role in the trial experience.
Overcome inertia by starting small.
Many investigators, sponsors and CROs are often hesitant to move from the familiar model of central trial sites where patients receive assessments and lab work onsite. Rather than move the entire enterprise to DCTs at once, identify the best study candidates for DCT modalities, partner with early adopters, prove success and then share results with others throughout the enterprise.
Be clear with the early adopters of DCTs that not every technology and process that works in a pilot or test phase will work in a full-scale study, and they should expect to learn from challenges. A modular approach to designing the DCT platform, companion apps and other features will make it easier to scale trials to other therapeutic areas while customizing them for other trials.
Begin creating DCT protocols early in the treatment development process to account for new requirements such as training technicians to handle dry blood samples vs. frozen liquid blood. Also, create a roadmap for scaling DCTs over time that accounts for challenges such as shipping sensors to various geographies, capturing device data, training material translations and creating reporting tools for multiple users. This will prevent early DCTs from becoming “one-off” experiments that fail to deliver scale and value because they cannot be industrialized for use across the enterprise.
Prove return on investment (ROI) by meeting specific clinical challenges.
DCT costs for technologies such as wearable sensors, document systems and device and data management can be considerable, and it may take longer than expected to prove the value of the data produced. To build the business case, define the clinical and business challenges that can best be met by more patient-friendly DCTs, and where the generated data can offer the quickest return.
These might include trials that involve non-standard dosing regimens, (such as those that must be adjusted based on each patient’s absorption of a drug or response to it) or populations with a historically low rate of adhering to trial protocols. In such cases, “smart” dispensers that transmit a signal to the investigator, for example, that a pill bottle has been opened, or real-time tracing of biomarkers, such as blood potassium levels, can allow real-time intervention to ensure proper dosing and better interpretation of biomarker results.
Defining specific technology requirements will help platform selection. To help prioritize efforts, develop a checklist of considerations for when and how DCTs work best. Questions to help design an effective DCT include:
If a patient fails to take their medication on time, does the investigator need to intervene immediately for health or trial reasons, or just note their non-adherence after the fact?
Will the investigator use patient data only to refine the trial protocols, or to prove label claims (the legal representations of what a drug can and cannot do)?
How should the types of devices, the data required from them, and their ease of use vary for different patients — for example, a diabetes patient skilled in tracking their insulin levels or an Alzheimer’s patient who’s cognitively impaired?
How could companion apps help foster engagement and accountability in patients and enable communication with them?
Consider working with partners and even competitors to develop standards for common metrics used across trials, such as how to interpret heart rate data or steps taken captured by fitness sensors. Eliminating the need for each organization to develop these metrics frees them to focus on areas where they can add value and realize a return, such as the creation of new treatments.
Engage regulatory and security experts early.
Regulatory approval for the protocols and data associated with a DCT is an understandable concern for investigators, sponsors and CROs. Those concerns are fading, however, as regulators are increasingly open to working with stakeholders to find creative ways to continue clinical trials despite COVID-19 lockdowns. We expect this receptiveness to DCTs to continue post-pandemic as pharmaceutical companies realize their potential to reduce costs while increasing and broadening patient participation.
Because many emerging technologies lack sufficient clinical validation for use as a primary data source, DCT teams may need to calibrate and verify “endpoints” — the devices such as wearables that monitor patients’ conditions at home. This means ensuring that, for example, a specific brand of wearable sensor provides consistent and reliable measurements of potassium levels in a patient’s blood and understanding how measurements delivered from a sensor compare with those derived from more conventional measures such as a blood sample.
Note also that regulatory requirements for the data produced by such endpoints may differ for data used only for internal decision-making, such as modifying the trial protocols, and data used for diagnostics or approval purposes. Working with regulators early in the trial process can help clarify these issues and lead to new approaches that allow for safe use of such data.
Security is another area where engaging experts, such as a risk assessment team, early can help speed and reduce the risk of a DCT. Most trial teams are familiar with long-standing requirements for protecting patient and other data in clinical studies. Those same trial teams may be much less familiar with how to protect data from remote sensors transmitted over Bluetooth or near field communication (NFC). We recommend working with security specialists on a case-by-case, device-by-device basis to understand what encryption and other protection is required for each.
COVID-19 shutdowns have slowed many clinical trials. But the need to continue such trials when patients cannot visit traditional sites has also shown how digital technology can decentralize the trial process while improving outcomes for patients, investigators, sponsors and CROs. Focusing on clinical benefits rather than technology, starting small and engaging all stakeholders early on are keys to success.