Table 1.
Best Practice Considerations When Desgining Trials Using Digital Technologies1
| • Select technologies based on study research questions, intervention, endpoints (what is going to be measured), population targeted and overall design features. |
| • Expand trial teams to include technical, regulatory, clinical, operations, and patient expertise. Use their wisdom during study design, as well as implementation and data monitoring. |
| • Consult with leadership officials regarding critical infrastructure to support digital technology needs. |
| ○ Need for hardware, software, equipment, physical space, critical expertise, training, etc. needed to support the digital tools, maintain participant safety and well- being and ensure data privacy and accuracy. |
| • Follow a user-centered approach in study design, considering technology development and refinement before technology tools are selected (include participants and relevant clinical staff). |
| ○ Be mindful of potential participants preferences, as well as issues regarding geographical challenges in accessing Internet. |
| • Consider/anticipate participant privacy/confidentiality issues when selecting digital tools. |
| • Prepare data and safety monitoring plans considering the technology used and potential issues that could impact participant safety, privacy, and wellbeing, as well as risks to data integrity. For example, consider issues like technology updates, server hacking, data sharing, and potential loss of study data. |
| • Sometimes the best approach could be a combination of digital approaches (wearables, smartphones, web portals, virtual reality, mobile apps, telehealth, social media, electronic records, registries, machine learning, etc.) with more traditional activities requiring participants to visit a study site (sample collection, medical procedures, measurements, interventions). |
| • Consider regulatory status and IRB requirements. |
| ○ Review local IRB guidelines regarding e Consent and using digital tools. Consult with IRB early on, describe plans, and discuss potential issues that may impact study timeline. It is important to discuss procedures and concerns when the investigator is seeking waiver of consent |
| ○ Consult drug/devices approval regulations with appropriate regulatory agencies for trials using technology for the purpose of drugs/devices approval. |
| ■ FDA/OHRP/EMA have issued key documents to assist investigators on this area. |
| • Conduct a feasibility study prior to the main trial to understand access to and preferences for technology use in your target population and study staff, as well as troubleshoot infrastructure issues and capacities at study site. Often, the best tool(s) are those that simplify study operations for the user. |
| • Collect only the minimum data necessary for study endpoints; be mindful of big data challenges as well as issues with data quality. |
1
Adapted from the Clinical Trials Transformation Initiative (CTTI) Digital Health Trials Program (https://www.ctti-clinicaltrials.org/programs/mobile-clinical-trials)