Digital Clinical Trial Platform for Remote Patient Engagement and Data Collection

The challenge

Traditional trials depend on visits at the study site. That limits who can take part and how often data can be collected. Over long study periods, participants can drop out, and manual data handling makes follow-up harder. This applies especially to behavioral and psychological research.

The solution

SwissDTx moves part of participation into an app. Participants receive questionnaires and study-specific content on their own device and complete them where it suits them. Research teams follow participation remotely and plan site visits where they are needed.

How SwissDTx fits into a study

1. Before the study: define which content and assessments participants receive.
2. During the study: participants take part from home on their own device, and the team follows participation.
3. After data collection: the team reviews what participants completed.

Example: a hybrid study

Illustrative example, fictional.

A research team runs a six-month study with questionnaires every two weeks. Instead of scheduling each time point at the study site, participants complete the questionnaires in the app. The team follows who has completed what and keeps on-site visits for the points that require them.

Evidence and credibility

• SwissDTx was used in the LeukoKids study.
• Meta-analyses of studies comparing paper and electronic versions of patient-reported outcome measures found the two to be comparable [1, 2].
• Decentralized trials move some study activities away from the study site. Research teams should check requirements early, because regulatory frameworks for decentralized trials are still developing in many European countries [3].

References

1. Gwaltney CJ, Shields AL, Shiffman S. Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: a meta-analytic review. Value Health. 2008;11(2):322-333. DOI
2. Muehlhausen W, Doll H, Quadri N, et al. Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013. Health Qual Life Outcomes. 2015;13:167. DOI
3. Decentralized Clinical Trials: Governance, Ethics and Medico-Legal Issues for the New Paradigm of Research with a Focus on Cardiovascular Field. Medical Sciences. 2025;13(4):222. DOI

FAQ

What is a decentralized clinical trial?

A decentralized clinical trial moves some or all study activities away from the study site, for example by letting participants complete assessments from home. Hybrid designs combine remote and on-site activities.

What is ePRO?

ePRO stands for electronic patient-reported outcomes: questionnaires that participants complete on a digital device instead of on paper.

Are electronic and paper questionnaires comparable?

Meta-analyses found that patient-reported outcome measures completed on paper and on electronic devices give comparable results [1, 2]. This holds for measures migrated with care, so research teams should still check each instrument.

How does SwissDTx support research teams?

SwissDTx lets participants complete assessments and structured content in an app and lets research teams follow participation remotely. SwissDTx delivers and manages digital content. Diagnosis and treatment decisions remain with the professionals.

Which studies has SwissDTx been used in?

SwissDTx was used in the LeukoKids study.