On New Clinical Research Methods and Technologies

From decentralised designs to Artificial Intelligence

Abstract

What types of innovative clinical studies are we expecting for the coming years? Four main trends are becoming clear.

Firstly, we will see technological solutions, apps and platforms, becoming widely available to support trial designs. Electronic informed consent (eConsent) and web-based questionnaires are two new trial elements to influence methodologies. Especially relevant is that eConsent, the digital consent process for patient enrolment to confirm participant comprehension is significantly streamlining clinical research overall.

A second key trend, is the adoption of decentralised and hybrid clinical research design. Decentralised designs are expected to reduce research costs and te adoption of telehealth will significantly reduce study administration costs, and improve recruitment and participant retention

A third key trend is the adoption of electronic patient-reported outcome (ePRO), another technology that will gain significance in parallel to the growth of real-world evidence (RWE) and real-world data (RWD) which are more widely accepted as methodologies. One procedure that will become common being ePRO allowing patients to complete and submit information about symptoms, side effects, drug timing and more, using electronic devices related to clinical research.

A fourth key trend, will be adoption of artificial intelligence (AI), Big Data, application programming interfaces (APIs) and digital platforms expected to improve patient selection, enhance data collection, integration and analysis, while at the same time reduce time, this level of digital transformation would improve both pre-clinical and clinical research.

Clinical trial data is diverse and multi-modal. It can come from patients, clinicians, devices such as wearables and other sources. This being a key change in clinical research occurring at fast pace, will change clinical research publishing too.