Real-world data in the United Kingdom: opportunities and challenges

Abstract

Real-world data is that collected outside the constraints of controlled clinical trials and is increasingly informing decision-making in healthcare. The landscape of real-world data in the United Kingdom is set to evolve over the coming months as the government plans to build on databases currently in place by collecting patient data from all family practices and linking this information with hospital records. This initiative, called care.data, has the potential to be an invaluable resource. However, the programme has been criticized on grounds of data privacy, which has led to an extended delay in its implementation and the expectation that a large number of people will opt out. Opt-outs may introduce substantial biases to the dataset, and understanding how to account for these presents a significant challenge for researchers. For the scope and quality of real-world evidence in the United Kingdom to be realised, and for this information to be used effectively, it is essential to address this challenge.

From Population Databases to Research and Informed Health Decisions and Policy

“…In England, clinicians and suspicious patients must be convinced that the needs and benefits of collecting and using “big data” to help improve patient care, and make the national health system more efficient, outweigh the risks ( 106 ). Moreover, the governmental care data program, which plans to bring together health and social care data from primary and secondary care and make them available to “approved groups of users” (including researchers) has been criticized on grounds of data privacy, which has not only led to an extended delay in its implementation ( 107 , 108 ), but also to the expectation that a large number of people will opt out ( 109 ). One must keep in mind that scattered, disorganized data may bias and become a hindrance, so that intensive, yet prudent, efforts should be considered while implementing such a move.…”

Can real-world data really replace randomised clinical trials?

“…Real-world data (RWD) are data that are collected outside of RCTs [2]. They are gaining increasing attention for their use in regulatory decision-making.…”

Betahistine in the Treatment of Peripheral Vestibular Vertigo: Results of a Real-Life Study in Primary Care

“…6 It is for this reason that real-world data have become important arguments for health decision-making, since they can be used to understand the effectiveness of treatment and to provide an idea of the patterns of care, the safety of medicines in the long term, the use of health resources, and the epidemiology of diseases. 7,8 Based on the described problem, where on the one hand is vertigo as a frequent condition in primary care, which affects the quality of life of those who suffer from it 9 and on the other hand, the need to have results obtained from the real world, this investigation was developed with the objective to establish the clinical effect and the safety of betahistine for the management of vertigo in the context of an observational study, developed in real-life conditions, in patients treated by a group of general primary care physicians in Colombia.…”