In response to the pandemic, research teams around the world embraced decentralized clinical trials (DCTs) to keep patients and investigators safe, but industry aspirations around DCTs seem to have outstripped realities on the ground. While it is fashionable to talk about fully virtual or “site-less” trials, cancer patients today require complex infusions and advanced imaging that are simply not available in in-home settings. Therefore, many trial sponsors and their clinical research partners favor a hybrid model for cancer DCTs, combining on-site and virtual approaches to meet the needs of patients, investigators, regulators and brand owners.
Achieving the optimal on-site/virtual blend
Syneos Health advises clients and partners in the hybrid DCT space to build up three key capabilities that can enhance patient comfort and convenience while ensuring data privacy and integrity.
- Screening: Powerful tools enable sponsors to identify subsets of cancer patients using biomarkers and approach them through direct-to-patient outreach. Also, while decentralization is the overarching theme, central sites continue to obtain tissue for testing, allowing for a wider collation of patient data and minimizing of site burden in the screening process.
- Home Health Nursing: Oncology site visits are often lengthy, with complex diagnostic and dosing regimens. A properly designed hybrid DCT identifies which pre-treatment assessments can be done in patients’ homes, while on-site visits are limited to those requiring physician-facing activity.
- Long-Term Follow-Up: Consistent with the DCT’s direct-to-patient approach, sponsors may ease patient burden using emerging technologies such as “tokenization.” The goal is to link up health data that exists in numerous formats and repositories under one persistent code (a token), which can give researchers, providers and patients access to ever-expanding bodies of relevant health information without compromising patient privacy. By using central sites to perform much of the study follow-up, research teams can take pressure off smaller, dispersed research sites, freeing them to focus on studies in more active phases. While it may seem ironic, central monitoring has an expanded role in decentralized models, ensuring quality, consistency and integrity of patient data as home-based data capture and monitoring technologies proliferate and diversify.
Building a Decentralized Research Tool Kit
Sponsors and their partners must prepare themselves to work in a DCT environment. For this, we recommend building a DCT toolbox that can be flexed and adapted depending on the needs of each protocol. Thinking through the patient journey and the different stages of a protocol design and operational delivery, Syneos Health created a workbench of services, systems, tools and processes that lets the user tackle all elements of trial deployment. Like traditional studies, a hybrid decentralized trial begins with study design and protocol development—ideally involving close consultation with regulators and payers in key markets.
The next steps are patient identification, recruitment and enrollment followed by data collection, patient monitoring, drug supply-chain management and patient engagement. Because hybrid trials can differ significantly from traditional trials, it’s important to create data maps that always ensure data integrity.
Has your team considered all of the elements that are required to make a DCT successful? Learn more about how Syneos Health can help you with problem-solving for customized decentralized solutions.
Contributor:
Sarah Gillespie, Associate Director, Decentralized Solutions, Syneos Health
