"JCI is exploring ways to diversify and enhance the conventional trial model with the help of evolving technologies and big data analytics. The goal is to enhance patients’ experience and improve clinical operational efficiency."
Dmitri Talantov, M.D.
Senior Medical Director, JCI
Direct-to-Participant Trial Model
Clinical trials typically recruit patients based on geographic proximity to participating study sites. Conventional site-centric data collection usually requires frequent trips to sites. These not only make participation burdensome for both patients and sites, but also limit the diversity of the patient population.
In partnership with different teams across Janssen, JCI is building the internal infrastructure necessary to launch a direct-to-participant (DTP) trial model that brings clinical trials into patients’ everyday lives. JCI continues to invest in remote clinical trial capabilities and expand innovative approaches to clinical trial conduct and research, by exploring initiatives, such as:
- Home Healthcare Nurse Program: Piloting and rapidly implementing a program that supports clinical trial participation from a patient’s home, with nurses carrying out tasks that can be completed away from the physical clinical trial site, such as: vital measurements, biological sample collections and study compliance checks.
- Telemedicine: Partnering to enable the capabilities for physician-patient assessments and communications via video chat to ease the travel burden and number of in-person consultations for those participating in clinical trials.
- Direct Medication Shipment: Delivering study medication directly to clinical trial participants, removing the need to visit the clinical trial site.
- Local Care Model: Bringing clinical trial participation closer to home and into community locations, allowing more complex and elaborate assessments to be completed compared to a home-based setting.
A readiness cohort, or trial-ready cohort, represents an enriched group of potentially eligible study participants, identified and established using real-world data and evidence, such as insurance claims data or patient registry data. Rather than only using the anonymous data entries in EHR, patients who have consented can be contacted to collect additional data in an effort to further assess eligibility and decrease screen failure rate.
A readiness cohort can be particularly useful when there are enrollment challenges: for example, it is important to pre-identify and pre-engage for rare diseases, or if there is a narrow enrollment window for acute diseases.
JCI is currently creating a readiness cohort for an existing portfolio study leveraging EHR and a mobile app to support recruitment. The mobile app was developed to pre-screen and pre-register patients, as well as to provide disease- and trial-related materials and symptom tracking assistance to prospective patients. Once patients report eligible symptoms on the app, the app will automatically trigger the communication channel between patients and a clinical trial site.