Table 1 Clinical trials transformation initiative (CTTI) recommendations for dealing with data collection from mobile technologies (Adapted from ref. 41).

From: Digitizing clinical trials

1

 

Design the mobile technologies using evidence-based principles. Address clearly user-centered design principles in developing and choosing technology. Proactively address data privacy and security with user input.

2

 

Collect the appropriate dataset necessary to address the study aims:

 

a

Evidence-based principles should drive decisions about the quantity of data to be collected,

 

b

Ensure that appropriate metadata are collected to provide sufficient contextual information to understand the data captured by mobile technologies while minimizing the collection of intrusive data, and

 

c

The most appropriate measurement intervals and optimal sampling frequency for a given outcome should be determined during development of the study aims.

3

 

Optimize data collection. When using mobile technologies for data capture, a multi-pronged approach to optimize data quality and missing is necessary, with efforts focused on:

 

a

Optimizing trial design,

 

b

Including appropriate strategies for monitoring and optimizing data quality,

 

c

Ensuring technical approaches are in place to address technology-related or transmission-related causes of missing data,

 

d

Identifying acceptable ranges and mitigate variability in data collected via mobile technologies, and

 

e

Piloting testing to identify any unanticipated causes of missing data.

4

 

Proactively plan for the analysis of data captured using mobile technologies.

5

 

Establish common metrics, norms and/or standards to drive the successful scaling and more rapid acceptance of mobile technologies for data capture.