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Decentralized Clinical Trial Services
Decentralized trials offer greater flexibility when conducting clinical research, as participants can take part in trials remotely. A more patient-centric trial design, these studies increase participation and lower costs, while securely capturing key data points.
Remote and Virtual Trials
Conducting clinical trials can be expensive and time-consuming. If your trial is studying rare diseases or includes pediatrics, eligible participants can be spread over a large geographic area. Some patients may also find it difficult to travel because of their health or transportation constraints. As the COVID-19 pandemic demonstrated, limitations on clinical trials can be overcome by employing technology and other home-based options to surmount obstacles related to access, mobility, and a limited pool of eligible participants. Accessible trials also increase convenience for both you and your patients, helping increase retention rates and improving diversity in the study population.
Leveraging Real-World Data for Optimal Trials
In decentralized clinical trials, real-world data (RWD) plays a crucial role in streamlining various aspects of the trial process.
The benefits of RWD:
- Enables comprehensive feasibility analysis allowing for more accurate and digitalized patient screening.
- Supports digital audits to ensure high-quality reporting by comparing data captured electronically with original source data.
- Facilitates remote monitoring of trial participants, enhancing the efficiency and effectiveness of data collection.
- Integration of eSource methods allows for seamless uploading and real-time analysis of data, further optimizing the trial process.
Constructing meaningful clinical endpoints
Trial data gathered through enhanced means of collection provides additional context throughout the development lifecycle.
Validating digital biomarkers
Additional and frequent updating of available information provides additional proof of accuracy in the selection of biomarkers that matter.
Addressing regulatory challenges
Our teams are experts in the global regulatory landscape and work closely with you to anticipate challenges and propose solutions.
Statistical validation
With decades of experience in biostatistics throughout the development lifecycle, our team curates and validates your data with rigor.
Remote Trials
Our expertise in remote trials and in addressing concerns that arise from dispersed data and populations is deep and wide-ranging. Remote trials increase convenience for your study participants and may increase overall participation rates. Trials with remote elements eliminate some of the burden on patients by incorporating touchpoints that are home-based. This can involve phone calls and emails, or paper forms, and can help with capturing data in real-time, rather than relying on in-person encounters which can depend heavily on memory. Cytel enhances these efforts by applying advanced data integration techniques and analytics to handle diverse data types effectively, ensuring you benefit from high-quality, actionable insights that are derived from each participant interaction, regardless of format or source.
Virtual Trials
Virtual trials allow you to leverage available and developing technologies, such as wearable devices, apps, telemedicine encounters and other remote monitoring tools. They also allow for more continuous monitoring, allowing more data to be collected. Wearable devices, which have played a greater role in patient monitoring in the recent past, have demonstrated their value and ease. Continuous monitoring through wearables also provides critical contextual information, as patients may respond differently during trials daily. Using wearables enables your team to take these critical but subjective parameters specific to a patient’s daily experience and try to make them more objective.
Adding a virtual element to your clinical trial enhances flexibility for you and your patients. It also continuously evolves the field, as new technologies can be seamlessly adopted as part of a more comprehensive approach to increasing study access and participation. We enrich this evolving landscape by applying sophisticated biostatistical methods and predictive analytics to rigorously analyze the diverse and voluminous data generated, optimizing your trial outcomes and ensuring robust, scientifically sound conclusions.
Decentralized Clinical Trial Insights
Learn more about how our expert strategic consultants can help you determine the best study design options for your trials, including a range of options that save costs, increase patient convenience and impact participation.
Stay ahead of developments in remote and virtual applications in clinical trials by subscribing to our blog for updates on this evolving field, and the role Cytel’s experts play within it.
Learn More30%
Increase in patient recruitment rates with DCTs
50%
Improvement in patient retention with DCTs compared to traditional
80%
Satisfaction rates reported by patients included in DCTs
70%
Clinical trials incorporating at least one decentralized or virtual component
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