Chief Scientific Officer Seastorm Limited Cardiff, Wales, United Kingdom
Disclosure(s):
Will Webberley, PhD: No relevant financial relationship(s) with ineligible companies to disclose.
Tom Webberley, PhD: No relevant financial relationship(s) with ineligible companies to disclose.
Objectives: Human trials are the tried-and-tested gold standard of product testing, whether it’s pharmaceutical or nutritionally focused. However, the classical human trials approach comes with a number of problems for researchers, sponsors and participants. These include: (i) Costly administrative burdens, (ii) Disparate data collection methods (paper, emails, phone calls, fax), (iii) Data ambiguity/Poor data quality and (iv) Restricted data capture options. While newer digital ways of working enable researchers to partially overcome some of these issues, mistakes can still be made and the capture of desirable additional metadata (including automated body mass index (BMI) values, food diary intake items and cognitive testing data) is still limited. The objectives are to address these shortcomings via Trialflare, a data capture solution for trials on web and smartphone by (i) evidencing accurate data capture on the platform, and (ii) producing novel and flexible data types for the collection of useful supplementary metadata such as BMI, food diary entry data and cognitive testing data in one single space.
Methods: Novel data types, including automated BMI calculators, food diary data entry and cognitive testing features were created and implemented into the existing Trialflare web and smartphone app. Anonymysed participants tested this in the app in a test trial and provided feedback.
Results: The novel data types created enabled the automatic capture of BMI, nutritional metadata of common food and drink items that were logged by participants and cognitive performance data on both the web and smartphone app.
Conclusions: Trialflare is an effective data capture platform for human studies and trials capable of capturing a variety of validated data types accurately and securely for multi-disciplinary purposes. Trialflare is able to collect additional metadata which could not be obtained by other traditional methods.
