The use of mobile technologies has the potential to transform clinical trials. What has been missing is a clear road map for overcoming perceived complexities and making this vision a reality—until now.

Once a sponsor has decided to use a technology-derived outcome measure (see CTTI’s Mobile Clinical Trials: Novel Endpoints recommendations and resources), there are many decisions related to selecting the technology, capturing and handling data, and designing the protocol. CTTI has developed solutions that outline best practices for the use of mobile technologies to capture objective data—an approach that has the potential to transform the quality and efficiency of clinical trials.

Scientific and Technological Issues Surrounding the Use of Mobile Technologies in Clinical Trials (2016 – ongoing)

This is just one project within CTTI’s Mobile Clinical Trials (MCT) program. Additional work within CTTI’s MCT program includes:

• Recommendations and resources on selecting, developing, and including technology-derived novel endpoints in clinical trials
• Development of recommendations and resources that provide solutions to actual and perceived challenges to conducting decentralized clinical trials (DCTs)  
• Development of recommendations and resources to leverage patient and investigator's perceptions of using mobile technologies in clinical trials

The goal of CTTI’s MCT program is to provide a comprehensive, intuitive toolkit of recommendations and resources for every stakeholder using mobile technologies for data capture in clinical trials—including recommendations for conducting a complete or hybrid decentralized clinical trial.

The MCT Mobile Technologies project specifically addresses the scientific and technical considerations that follow the decision to collect technology-derived outcomes data in a clinical trial. The resulting work provides a road map for using mobile technologies to capture objective data—an approach that has the potential to transform clinical trials and improve data quality, efficiency, and patient centricity.

CTTI’s mobile technologies recommendations and resources provide stakeholders with comprehensive guidance to support the inclusion of mobile technologies for data capture in clinical trials. Ultimately, this will improve the quality and efficiency of medical product development.

• Expert interviews
• Expert meeting

CTTI conducted interviews in two phases. First, we solicited input from research sponsors and clinical investigators experienced in using mobile technologies in clinical trials. These preliminary results revealed challenges related to data management, validation, analysis, and security. Sponsors and investigators shared their approach to mobile technologies selection as well as to managing and reporting safety signals and adverse events. The preliminary results were shared in a CTTI webinar.

A second phase of interviews with technical experts (device manufacturers, data management experts, data security experts, and data analysts and biostatisticians) examined evolving best practices among sponsors and investigators and probed solutions to specific technical issues that have continued to challenge studies relying on mobile technologies for data capture.

In June 2017, CTTI convened a multi-stakeholder expert meeting to explore solutions to the scientific and technological challenges of using mobile technologies in clinical trials. Themes from the meeting included:

• Best practices for studies using mobile technologies for data capture do not differ significantly from many of the best practices already applied to clinical trials.
• Studies using mobile technologies for data capture should not be held to higher standards than traditional trials.
• This effort should strive to engage patients in study design.
• Existence of the technology should not drive the decision to incorporate a mobile technology for data capture—rather, that decision should follow the identification of a technology-derived measure that is better than existing alternatives.
• The mobile technology should be fit for the purpose of collecting data to support the endpoint for the particular patient population. 

A meeting summary is available that highlights themes from these discussions.

CTTI also convened a Recommendations Advisory Committee, a team of clinical trials and technology experts, to provide ongoing feedback to the recommendations during development, and help shape the supporting resources—ensuring that the final solutions are useful, applicable, and impactful.

In July 2018, CTTI released the final recommendations for the use of mobile technologies for objective data capture in clinical research. The full set of evidence-based recommendations and resources includes case examples, frameworks, decision tools, flowcharts, and more, which offer practical guidance for:

• Selecting mobile technologies for data capture that are appropriate to the trial;
• Capturing complete, attributable, and high-quality data;
• Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues;
• Designing and executing a protocol that uses mobile technologies for data capture; and
• Preparing for FDA submission and inspection.