Traditionally clinical trial outcomes are recorded as single reports (often with handcrafted
Narrative descriptions) at face-to-face research clinic visits. Typically, original medical records are gathered, copied and couriered to a trial coordinating centre, and then verified by trial clinicians according to pre-specified rules. The process is inefficient, expensive, and prone to errors.
We are looking back into previous trial datasets linked to other routinely collected medical data, acquired during people’s usual care, to identify more streamlined, and potentially more reliable methods to cost-effectively collect information for trials with fewer steps, with a particular focus on vascular outcomes and bleeding outcomes.
We are also developing methods to rapidly ascertain outcomes relevant to Covid-19 trials using the RECOVERY trial platform, which has recruited and started following about 40,000 participants in the UK since the beginning of the Covid-19 pandemic: https://www.recoverytrial.net/
Two years on from RECOVERY: paving the way to a data-enabled future for clinical trials
22 March 2022
On the second anniversary of the RECOVERY trial, we look at how access to routine clinical healthcare data was a key element of its success in finding treatments for COVID-19. And how...
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
21 September 2021
Overview Patient Reported Outcomes (PROs) can provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from...