The transition to patient-centric clinical research
Patient-centricity has become a hot topic in clinical research. After many decades of product-centric clinical development, industry stakeholders are now looking to ‘put the patient first’ by reshaping the patient’s role from research subject into informed collaborator. In this article, we zoom in on the emerging concept of patient-centricity, interpreting its meaning and explaining key related trends and developments. We also cover the role of Triall in advancing patient-centric clinical research.
An introduction to patient-centricity
Better alignment between product and patient
Encouraged by regulators and health authorities around the world, patient-centric clinical research aims for a better alignment between new medical products (e.g., drugs, vaccines, or medical devices) and the patients using these products. By promoting meaningful patient engagement throughout the drug development process, patient-centric initiatives aim for optimal consideration of patients’ individual needs, wants, and perspectives. Hence, these initiatives promise to address a long-standing disconnect between patients and industry.
Issues surrounding patient engagement
The recent surge in patient-centric initiatives signals an industry-wide response to rising drug development costs — which currently are at an all-time high due to development inefficiencies, mounting delays, and high failure rates. In part, high development costs can be attributed to issues surrounding patient engagement. To illustrate, 85% of clinical trials struggle to recruit enough patients, 80% experience delays due to enrolment issues, and the average drop-out rate is estimated to be around 30% (Clinical Leader, 2022).
Involving and engaging with patients
Except for the predetermined patient visit schedule of a clinical trial, involvement of patients in clinical research has traditionally been limited and infrequent. With the growing recognition of patient-centricity, industry stakeholders are now looking to adopt and implement patient-centric initiatives along the full clinical trial life cycle.
Patient-centric clinical research in 2022
Decentralised trials for a better patient experience
The transition to patient-centric clinical research is being fuelled by technological advances, which have enabled a more ‘decentralised’ approach to clinical trial operations. Nowadays, clinical trials increasingly take place outside of the ‘centralised’ hospital setting by leveraging telemedicine and mobile engagement tools. These tools enable data capture, doctor-patient interaction, and personalised reminders from virtually any location, meaning patients can participate in research from the comfort of their own homes. In this way, decentralised trials promote a better patient experience by increasing convenience and minimising the burden of participating in clinical research.
Low-cost patient-centric initiatives
While decentralised trials are certainly a step forward, patient-centric clinical research is not only about increasing convenience through technology. The Drug Information Association (DIA), Tufts Center for the Study of Drug Development, and 17 other stakeholder organisations conducted a study in which they quantified and defined 30 patient-centric initiatives utilised in clinical research and outlined evidence-based metrics to gauge the impact of these initiatives (Stergiopoulos et al., 2020). The study concluded that low-cost initiatives such as patient advocacy group involvement, patient advisory panels, and focus groups generated the highest return compared to some of the more costly initiatives such as gamifying electronic Patient Reported Outcomes (ePRO). According to the researchers, low-cost initiatives played a key role in streamlining drug development by promoting faster trial planning, regulatory approval, and study enrolment as well as less patient dropouts and protocol amendments. This is good news for clinical trial sponsors as it suggests that they can save millions with relatively small investments of resources.
👉 Example: involving patients in study design and execution
TransCelerate Biopharma, an industry-renowned non-profit that aims to harmonise and streamline drug development, has created two low-cost methods that promote a better patient experience by using patient feedback in clinical trial design and execution. Their Patient Protocol Engagement Toolkit (P-PET) offers tools for engaging with patients and caregivers in the design of the study protocol and their Study Participant Feedback Questionnaire (SPFQ) toolkit offers a standardised and validated survey that measures patient satisfaction at the beginning, middle, and end of a clinical trial. Both toolkits are publicly available and motivate patients and their caregivers to view clinical trials in a more collaborative nature.
Enabling patient-centric clinical research with Triall
As a software provider to the clinical research industry, Triall aims to enable sponsors, CROs, and sites in building and operating more patient-centric studies. As part of our end-to-end eClinical platform, we offer a range of decentralised trial technologies such as eConsent, ePRO, remote patient monitoring tools, and various options for wearable integration (and soon also telemedicine). These mobile-centered solutions help promote patient convenience by allowing patients to participate in clinical research from virtually any device and location. Moreover, we offer an affordable and flexible pricing model where clients can choose a configuration of solutions according to their specific needs and budget.
The next paradigm in patient-centricity
Self-Sovereign Identity (SSI)
Going forward, Triall will expand on its eClinical platform with a Self-Sovereign Identity (SSI) infrastructure that provides patients with more insight, ownership, and control over their participation in clinical trial processes. The first stand-alone product on this infrastructure will be an eConsent application where each patient is provided with their own self-managed identity, including a wallet of credentials that they can use to provide, update, and revoke consent throughout the trial.
The application is funded by an R&D grant from the Dutch government and leverages several emerging technology standards developed by renowned standards bodies such as the World Wide Web Consortium (W3C) and Decentralised Identity Foundation (DIF). It provides a privacy-preserving and verifiable means for consent management that forms the basis for other use cases, such as patient recruitment, data exchange, and data monetisation.