Flexible Virtual Trials for Patient­ centricity, Efficiency, and Better Data

Clinical Study - August, 2021

Decentralised, Virtual, and Hybrid Trials – all these terms refer to clinical trials that employ any number of methods to allow for more flexibility in how patients join and participate than the traditional clinical trial model. Strategies range from digital consenting tools to remote monitoring and telemedicine to direct-to-patient distribution of clinical trial materials to home health visits to cell-phone apps. These solutions aim to ease burdens associated with patient participation, provide access for a greater variety of patients, and improve compliance and retention, resulting in better data, reduced site burden, and faster trial completion. Innovative Approaches That Promote Patient Recruitment and Retention to offer a different clinical trial model.

Decentralised, Virtual, and Hybrid Trials -What’s the Diflerence?

Clinical trials designed to leverage a variety of methods that limit the need for patients to visit investigator sites go by many names. Confusion arises because these terms, such as decentralised,virtual, and hybrid, are used inconsistently. For some, decentralised might mean there is no central clinical research site, only a decentralised coordinator. Others equate decentralised clinical trials with any trial that applies a patient-centric approach and requires fewer patient clinic visits. For some, virtual trials enable patients to avoid site visits altogether – a design that is, in fact, very rare – whereas hybrid trials utilise a combination of traditional and virtual methods. Others use virtual loosely to mean the same thing as hybrid.
In the end, ail these terms refer to clinical trials that employ any number of methods to allow for more flexibility in how patients join and participate than the traditional clinical trial model where in all patient interactions occur at an investigational site. Strategies range from digital consenting tools to remote monitoring and telemedicine to direct-ta-patient distribution of clinical trial materials to home health visits to cell-phone apps. These solutions aim to ease burdens associated with patient participation, provide access for a greater variety of patients, and improve compliance and retention, resulting in better data, reduced site burden, and faster trial completion.

Innovative Approaches That Promote Patient Recruitment and Retention

Finding patients , keeping patients, and engaging with patients – these are critical for any clinical development programme. One of the best ways to find and retain patients is to offer a different clinical trial model – one where patients can be involved in the study in a way that allows them to enroll and stay in it while also balancing a busy schedule. For some patients, avoiding medical facilities may also be a priority. With the technologies available today, more organisations could embrace a site-visit limiting approach , which I believe would have a significant impact on the industry’s chronic inability to attract and retain a suffi.dent number of patients .

Hybrid Virtual Visit

With patients who have already been screened, consented, and enrolled in a study, sites interact remotely, often using an online video platform such as Zoom or Doxy.me. In this model, sites record patient observations and capture study data via electronic clinical outcome assessments (eCOA) as they would during an on-site visit. This setup allows patients to engage in the trial with minimal effort. At the same time, these direct patient interactions are key for patient retention, as they allow study teams to stay engaged and follow up with timely encouragement, appreciation, and reminders to staywith the study.

Patient interactions may include testing during the visit and/ or be supplemented with self-administered data collection (e.g., a home blood pressure cuff) or sensor-based data collection devices. Carriers specialising in logistics and supply chain for virtual clinical trials can be engaged for secure, documented, timely, climate­ controlled home delivery and pickup of clinical trial supplies and clinical samples . For patients not yet consented, eConsent by telemedicine may be possible. Explanations , ID verification, and reviewing of eConsent can ail be clone remotely.

Site-to-Patient Direct Data Capture (DDC)

Another option is to conduct home visits, bringing the site to the patient. The travelling study coordinator captures data electronically at the point of care. Data entry is guided by edit checks and data may be uploaded and made available to study tearns immediately. In cases where no internet connection is available, visiting coordinators can download patient data collection forms in advance and upload collected data later. This DDC model has been successfully used in many therapeutic settings to reduce patient burden while still maintaining contrai over the protocol execution and data capture.

It’s important to understand that DDC is distinct from electronic data capture (EDC). In many trials, data from various sources must be transcribed into the EDC tool – a time-consuming, error-prone process . With DDC and other eSource data capture methods, the original source data is entered direct/y into the electronic record, saving time, reducing errors, and eliminating the need for later verification. The success of virtual trials – and many of their advantages – hinges on this clean operational approach.

ePRO – Configured to Engage Patients and Improve Data Quality

Electronic patient-reported outcomes (ePRO) are an excellent tool for promoting patient adherence and retention while improving data quality. Patients record real-world data on mobile electronic devices, such as smartphones. The applications can be configured to deliver edit checks and reminders that promote adherence to study protocols. In addition, they can deliver study information and other communications that enable study teams to keep in touch, promoting patient retention. An additional advantage is that real-

BringYour Own Device (BYOD) ePRO

BYOD-enabled ePRO tal

Through greater patient-centricity, virtual trials reduce the clinical trial burden on patients, maldng participation more convenient and more attractive. They also offer a variety of opportunities to improve patient engagement and adherence to study protocols, increasing retention and data quality.

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