Non-interventional clinical studies, such as post-marketing, longitudinal, and observational studies, are extremely important for advancing our understanding of healthcare outcomes, treatment effectiveness, and patient safety over extended periods. These trials are different from investigational studies and our approaches to data collection, management and analysis require flexible mindsets. Using technologies that are just as flexible to help address challenges like integrating huge amounts of real-world data (RWD) from varying sources can help. The complexity and diversity of non-interventional studies necessitate a robust data platform that can handle a myriad of data types, all while providing a seamless and intuitive interface that researchers and participants can conveniently engage with.
A Quick Primer on Non-Interventional Studies
Non-interventional studies encompass a wide array of research methodologies designed to observe the effects of treatments without altering the standard of care. These include post-marketing surveillance studies that monitor the safety and effectiveness of drugs after they have been approved for public use, longitudinal studies that observe subjects over prolonged periods, and general observational studies that aim to glean insights into disease progression, treatment outcomes, and more.
The Integration of Web and Mobile Platforms
The clinical trial landscape is increasingly embracing digital transformation, with platforms that combine web and mobile capabilities taking the lead. This evolution is extremely beneficial for non-interventional studies, where participant engagement and compliance rely heavily on how easy it is for them to submit data. A unified platform that is accessible via both web and mobile devices, matched with an intuitive user experience, ensures that participants and study team can submit or interact with data in real-time, from anywhere. In terms of data collection, this enhances the richness and reliability of the research data, while allowing researchers the ability to monitor and react to data quickly.
Integrating Wearables
Platforms also need to be able to easily integrate data from wearable devices and sensors, increasingly important tools for non-interventional study data collection. Wearables offer a non-intrusive, continuous stream of health data, augmenting the dataset with objective, real-time insights into participant health and behavior.
Easy Incentivization
Integrating patient reimbursement technologies directly into the clinical trial platform can streamline participant payments and prevent dropout-causing frustrations. Longer-term studies can only be successful if participants continue to be engaged. Building reimbursement into your platform – the same platform participants are using to submit data or check in with clinical team members – you can remove one of the most common points of participant complaints and remove the need for study team members to follow up on questions from patients about getting paid.
Privacy
An all-in-one platform that prioritizes privacy and complies with global data protection standards ensures that participants’ information is secure, fostering an environment of trust and transparency.
Interoperability
Observational studies and registries rely heavily on existing healthcare data to allow researchers to draw more accurate and comprehensive conclusions. Platforms that facilitate interoperability between sources like Electronic Health Records (EHR) and Electronic Data Capture (EDC) systems facilitate more efficient data exchange, reducing redundancy and minimizing errors.
The Role of Mobile Communication and Multilingual Support
Using a platform built to enable mobile connectivity can significantly improve patient engagement and maintain high levels of engagement over the course of long-term studies. For example, the ability to send SMS notifications can help remind participants that it is time to send in an ePRO or fill out a quick eConsent. This feature not only helps patients keep up with their study responsibilities, it also maintains the flow of timely data.
The global nature of clinical research demands tools that transcend language barriers. Platforms offering web interfaces in multiple languages, coupled with mobile apps that adapt to the language settings of the user’s phone, ensure broader accessibility and inclusivity.
The Cloud and Multi-Tenant Architecture
Cloud-based platforms with architectures accessible by users through single-sign-on (SSO) help teams manage multiple studies across different clouds worldwide. This approach helps to ensure a consistent user experience and accommodates both open/public and closed registries.
Economic Efficiency
Cost is a critical factor in the viability and sustainability of any clinical trial. Non-interventional studies and registries tend to have tighter budgets and leaner resources than investigational studies. All-in-one platforms like TrialKit offer flexible pricing models that allow researchers to easily tailor solutions to their budgets. This cost-effectiveness, coupled with the platform’s comprehensive suite of features, enables researchers to conduct extensive, impactful studies without fear of hidden costs or overruns.
Conclusion
End-to-end clinical trial data platforms hold a number of key benefits for researchers conducting non-interventional clinical studies. Embracing these versatile platforms can help researchers to improve the user experience for both patients and study team members, leading to more consistent patient engagement and compliance, and higher quality data over the course of these long-term studies.
For more information on TrialKit and how best to leverage its suite of mobile and web-accessible capabilities for your non-interventional studies, visit www.crucialdatasolutions.com
