Clinical research is increasingly moving beyond traditional research sites. Participants can contribute data from home through mobile applications, surveys, wearable devices, and other digital technologies. These approaches create new opportunities for remote research, but they also introduce challenges around connectivity, data integration, and study workflows.
These challenges become even more pronounced in space, where researchers collect health data in environments with limited connectivity and no immediate access to traditional clinical infrastructure.
Space missions offer three practical lessons for decentralized clinical trials (DCTs): plan for connectivity limitations, design workflows around participants, and build systems that can manage data from multiple sources.
Bringing Research Closer to Participants
Decentralized clinical trials include activities conducted away from traditional research sites, such as remote data collection, telehealth visits, and in-home assessments. The FDA outlines these approaches in its guidance on decentralized clinical trials.
TrialX supports remote clinical research through configurable mobile research applications and data collection workflows tailored to study requirements.
For example, the SAYSTOP Study App supports research into antibiotic resistance by enabling participants to track and manage antibiotic use remotely. The FORETELL-Epilepsy app supports seizure research through participant diaries and wearable data, including heart rate and sleep information.
These applications show how researchers can collect participant-generated data beyond traditional clinical settings.
Adapting Remote Research Technology for Space
Remote research becomes more demanding when continuous connectivity cannot be assumed. Study systems must account for data that may need to be stored and synchronized later, along with the operational constraints of a space mission.
TrialX has adapted its clinical research and remote data collection technology through its work with the Translational Research Institute for Space Health (TRISH).
In 2021, TRISH selected TrialX to develop the EXPAND Database & Biorepository, a repository for research, flight, and relevant clinical data from commercial spaceflight missions.
TrialX has supported research associated with missions including Inspiration4, Axiom-1, Axiom-2, Axiom-3, Axiom 4 and Polaris Dawn.
In 2023, TRISH also selected TrialX to develop HERMES, an autonomous, offline-capable health data collection platform designed for environments where continuous connectivity cannot be assumed.
Managing Multiple Types of Research Data
Remote research can involve more than surveys and wearable measurements. Depending on the study, data may include electronic health record summaries, diagnostic images, biospecimen analysis, clinical assessments, and genomic information.
The EXPAND Database brings together data from space health research, including wearables, cognitive assessments, posture and motion measurements, ocular assessments, ultrasound, clinical records, flight and environmental systems, and genomics. The specific data collected varies by mission and study.
Managing these datasets presents a challenge. Genomic data, in particular, can be large and complex. Researchers need systems that can store and organize different data types while supporting secure access, integration, and analysis across studies.
What Clinical Research Teams Can Learn
Space missions offer practical lessons for decentralized clinical research:
- Plan for connectivity limitations. Study workflows should account for periods when participants cannot connect to the internet or synchronize data immediately.
- Design around participants. Remote study activities should fit participants’ environments and avoid unnecessary burden.
- Plan for multiple data sources. Research systems need to accommodate different data formats and volumes while keeping information organized and accessible.
TrialX applies its remote data collection experience across clinical research on Earth and space health research, adapting its technology to meet the requirements of each environment.
Frequently Asked Questions
What can space missions teach us about decentralized clinical trials?
Space missions highlight the importance of reliable remote data collection, offline-capable workflows, and integrating data from multiple sources. These capabilities are also important for decentralized clinical trials, where research activities take place outside traditional clinical sites.
What is a decentralized clinical trial?
A decentralized clinical trial includes trial-related activities conducted away from traditional clinical sites. These may include remote data collection, telehealth visits, in-home assessments, and the use of mobile applications and wearable devices.
How does TrialX support remote clinical research?
TrialX provides remote data collection solutions and configurable mobile research applications that help researchers collect study data through surveys, digital assessments, wearable devices, and other study-specific workflows.
How does TrialX support space health research?
TrialX has adapted its clinical research and remote data collection technology for space health research. Its work with the Translational Research Institute for Space Health (TRISH) includes the EXPAND Database & Biorepository and HERMES platform, which support research data collection and management in environments where connectivity may be limited.
Why is offline data collection important in clinical research?
Offline data collection allows participants and research teams to continue recording study data when an internet connection is unavailable or unreliable. Data can then be synchronized when connectivity becomes available, where the system supports this capability.
What is the EXPAND Database & Biorepository?
EXPAND is a space health research database and biorepository developed by TrialX in collaboration with TRISH. It aggregates and curates biomedical and clinical data from multiple space missions to support research and cross-mission comparisons.
What is the HERMES platform?
HERMES is an autonomous, offline-capable health data collection platform developed by TrialX for environments where continuous connectivity cannot be assumed. It supports wearable and digital assessment data, structured research protocols, and routine health monitoring.
