Beyond Clinical Trials: Connecting Clinical Research with Continuous Patient Care
From study-specific data collection and fragmented systems to a research platform supporting clinical trials, routine care and longitudinal research. 1. The traditional clinical research model Clinical research has traditionally been organised around a defined study and a specific research question. A medicinal product or treatment is investigated according to a protocol, with specified eligibility criteria, patient populations, endpoints, assessments and observation periods. Depending on the research question and development stage, this may involve Phase I, II and III clinical trials, randomisation, control groups and double-blind designs. Patients are recruited, data are collected, results are analysed and conclusions are drawn. Once the study is completed, its formal research activities come to an end. This model has been fundamental to the development and approval of medicines. It provides a controlled framework for assessing safety and efficacy. However, it also creates a separati...