It is critical to understand the needs and key drivers of a decentralised clinical trial – considering the target patient population when designing and deploying the trial. This enables the development of effective, highly targeted recruitment and retention strategies that improve patient diversity, communication, motivation and compliance, and increase engagement.
Patient insight
Patient insight, based on information from patient surveys, forums and focus groups and therapeutic specialist input, supports the identification of key milestones in the patient journey and can be used to put in place protocol-specific support solutions and patient engagement strategies, resulting in a more tailored, holistic, patient-centric approach.
Using the patient profile and the treatment pathway enables the development of customised digital recruitment outreach for the entire study. This holistic approach of focusing on building patient, caregiver and site awareness, as well as educating in the disease, builds a framework of support for the patient and establishes an early foundation for communications. Additional country-specific programmes may also need to be developed and executed to support more local factors affecting the patient.
Enhanced informed consent
When patients have been identified, deploying eConsent and using engaging, interactive- rich content in a digital format will support better patient understanding of the trial specifics and commitments, leading to better retention. eConsent can also feature an option for patients to query the details on procedures, allowing a fully engaged process.
Determining specific patient population needs
When designing a trial it is important that the sponsor considers the particular patient population enrolled in the study. For example, in a rare disease trial, the patient population may require family, guardians or other caregivers to help them travel to a site. This would also apply in research targeting paediatric or elderly populations. Providing direct-to-patient support and transportation services for patients with hindered mobility or patients in geographically remote locations recognises and addresses the particular challenges of this subgroup patient population.
Remote patient monitoring
Taking remote patient monitoring into consideration can ease the patient burden and enhance the patient journey for certain trials, therapeutic areas and patient populations.
It helps decrease in-person visits, saving time and enabling patients to participate in studies from the comfort of their own homes. The utilisation of telemedicine or at-home health services reduces or eliminates the amount of travel and associated costs often required for clinical trial participation, making clinical trials more accessible to more patients. Doctors, investigators and other medical professionals remain connected with their patients – often using devices patients are already familiar with – leading to fewer visits to trial sites, higher participation and increased patient retention rates.
Remote patient monitoring uses patient- centric technologies to improve health outcomes in the standard healthcare and pharmaceutical systems, including televisits, and the same technologies and telehealth may also be used in decentralised clinical trials to optimise efficiencies while obtaining quality data and giving patients convenient access to care.
However, there are still some challenges that – if not properly addressed during trial design – can reduce trial and technology accessibility. Looking at how these problems impact patients while developing trial protocols can help sponsors design and improve patient- centric clinical trials. Direct-to-patient help- desk support can play a key role in assisting patients when using monitoring devices, should they need help, and reducing the technology burden for investigator site staff. Usability assessment and feasibility, by listening to what patients do and don’t appreciate about the technology and incorporating their feedback into creating more accessible technology, is essential. It is really important that the patient feels supported at all stages if the use of remote monitoring is to be truly patient-centric.
Making it easier for the patient
As we consider the patient journey and the digital services deployed in decentralised clinical trials, we need to be mindful of the impact on patients. The focus needs to be on smart solutions that bring research to the patient, manage patient safety, streamline data collection and support study endpoints, delivering the promise of drug discovery and bringing treatments to patients more quickly. This involves providing options to patients that make participation easier and more convenient, whether that is at-home visits, remote monitoring or simply providing telephone support to help them to navigate the clinical trial.
Emily Mitchell is Executive Director, DCT Operations at ICON
