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Decentralized Trials: Considerations for Building a New Patient-Centric Model

BY GRACIELA RÁCARO, GLOBAL HEAD OF OPERATIONS, PAREXEL BIOTECH

During the past year, patients around the world waiting for new treatments have taken heart that clinical trials have been ongoing, despite the enormous logistical challenges posed by the pandemic. Some delays at the outset were inevitable. Yet, the industry has risen to the occasion. It’s been fantastic to experience the resilience and agility of the industry and how quickly sites adapted, in many cases embracing innovations to an extent that would have been unthinkable before now.

An Accelerating Trend

Paramount among these innovations is the rapid adoption of decentralized trials. Through this model, we have been able to keep clinical research moving to mitigate the challenges associated with in-person site visits, from travel restrictions to patients’ and investigators’ concerns about COVID-19 exposure. Data-driven remote patient-monitoring strategies have enabled business continuity, subject safety, data integrity, and study quality.

Regulatory bodies and payers have become more receptive to the technology advances that enable decentralized trials (DCTs). These include eConsent, wearables, telehealth, and telemedicine that reduce the number of on-site patient visits required to participate.

DCTs present the opportunity to drive toward a more patient-focused model – to design and implement trials with the patient experience at the heart. Strategic rethinking of every element of the clinical trial experience from the patients’ perspective can offer a compelling experience for participants, caregivers, and investigators alike, strengthening patient retention and adherence.

DCTs provide another important opportunity: to broaden participation and ensure that clinical trials reflect the target population while retaining the study’s rigor. DCTs enable the inclusion of those whose location, background, lifestyle, or availability may not have routinely been accommodated in clinical studies, thus promoting health equity and encouraging better-informed treatment decisions. This approach aligns with regulatory authorities’ expectations that sponsors will enroll participants who are candidates for receiving the therapy.

Operational Framework

Many companies, from big pharma to biotech startups, are establishing a strategy and scalable framework for conducting DCTs for the foreseeable future and beyond. Deliberative planning is wise because pivoting to DCTs is not a decision to be taken lightly, nor is this approach without challenges. Beginning with the patient experience, the first considerations are operational. How can you go about determining whether a trial can go virtual? What data collection methods are best adapted to a decentralized trial? Can your studies be adapted to promote remote patient monitoring, e-visits and video dosing regimens? Does your infrastructure and expertise encompass technology and tools such as video calls, mobile apps and digital health monitors? Can virtual assistants be implemented to improve compliance?

Patients’ Preferences

For every trial, it is essential to gauge patients’ willingness to engage in a different paradigm. Always approach trial design by asking, “What can I do to support patients in their home?” It Is recommended to seek direct advice on DCT protocol design from your target patient population and start early.  Also, consider engaging patient advisory boards and focus groups to review your DCT design to gain insights.  

Supply Chain Structure

Supply chain logistics also figure prominently into the equation. To operate effectively during the pandemic, depots and distribution centers have adapted their processes and working conditions to comply with local government restrictions. - In some cases, deliveries have been disrupted by drastic changes in airline schedules and routes. Decentralized and virtual trials might require a shift to direct-to-patient distribution from supply depots or delivery to a wider variety of sites such as community health centers. Site-to-site medication transfer may well be involved.

Needless to say, study teams need to consider the specific supply chain structure and challenges for the trial, examining continuity of medication delivery, site storage capacity, and possible adjustment of recruitment expectations, for example. Some companies have implemented an interactive response technology (IRT) system to help manage supply chain logistics and reduce drug wastage.

An Experienced Partner as Your Guide

As you weigh the many factors involved in trial startup or adapting your study design midstream, Parexel Biotech can guide you. Parexel Biotech is a pioneer in partnering with the industry to deliver DCTs and remote patient engagement strategies and has the experience and solutions to help you navigate the journey from pre-IND to Post-Approval.

Parexel is a founding member of the Decentralized Trials & Research Alliance, a new partnership of 50 life sciences and healthcare organizations that will be looking at policies, research practices, and digital health technology in DCTs. We also have initiatives to offer fully virtual and hybrid trial designs, boost clinical trial diversity, and educate patients and caregivers to promote awareness about clinical trials and build trust at the community level.

For more information on DCTs and Parexel Biotech, visit parexel.com/biotech