One of the most important developments in health care in the last decade is increasing involvement of patient- reported outcomes including diaries in a clinical study. The World Health Organization (WHO) claims that patient involvement in the health care industry is a social, economic and technical necessity. As such, data collection from patient/subject plays an important role that may impact the overall quality of the study. Growing digitalisation platforms will help to overcome many challenges associated with clinical data captured through paper diaries.
The utilisation of smart phones and mobile technology has simplified the capture of patient- reported outcomes and assessments. It also streamlines the steps to guarantee that the patients /study subjects report the data in a real-time fashion by tracking through entry date and time. FDA recommends that patients should record their information according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected1. This can represent a challenge to the study outcome; however, digital approach may help overcome this barrier. Studies using digital approach have evidence that it can control the recall period for entry of the patient-reported outcomes. In addition, capturing data through mobile or digital approach not only improves the compliance of data collection but it also enhances patient/subject engagement in the clinical trial.
In summary, the conduct of the 21st century clinical trial is more directed towards the capture of direct evidence from patients. Digitalisation can be used as a robust methodology and tool to cater for this new era of data collection.