The results of the Vaccine Response On Off Methotrexate (VROOM) trial were well reported in the press. The study has important implications for patients taking immune-suppressing drugs for diseases such as rheumatoid arthritis, and skin conditions like psoriasis. The researchers found that by pausing their medicines for two weeks, patients could see the antibody response to their COVID-19 vaccination booster doubled. For people shielding or taking extra care against COVID, the results are significant.
What was less visible to the public was the behind-the-scenes work from researchers from across multiple universities. Professor Abhishek at the University of Nottingham was the Chief Investigator and led the study in collaboration with the University of Manchester, Imperial College London, the University of Oxford, and Queen Mary University London.
The Oxford Clinical Trials Unit (OCTRU) at the University of Oxford managed the study conduct. The Unit has been designing, conducting, and reporting in both early and later phase clinical trials for almost 10 years. "Much of our portfolio is led from Oxford but we are always keen to collaborate when we feel we can add value. This study was an excellent example of collaboration to deliver something important for patient care." said Professor Duncan Richards, Director of OCTRU.
OCTRU operates a hub and spoke model which allows it to support multiple therapeutic areas, predominantly in musculoskeletal science, but also in oncology and surgical trials.
"One of the strengths of the clinical trial unit architecture in Oxford is that the different units are able to specialise. The Clinical Trial Service Unit (CTSU) and Primary Care run the very large platform studies Recovery and Principle in hospital and primary care respectively. OCTRU has expertise in early phase and moderate size phase 2/3 studies typically recruiting several hundred patients," commented Duncan.
VROOM needed to be set up and delivered at pace in order to catch the booster vaccine window for these at-risk patients. Delivery with these accelerated timelines required excellent collaboration between the clinical team led by Prof Abhishek and the trial delivery team in Oxford. "I want to acknowledge the vital contribution of the OCTRU hub team, trial managers, data programmers and scientists, and statistical team who all worked in a focussed and dedicated way to deliver this important study with actionable outcomes," said Duncan. "Their work is often in the background, but it is vital to the delivery of practice-changing research."
Professor John Iredale, Executive Chair of the Medical Research Council, which part-funded the trial, said: “This study shows yet again how the UK research community’s world-leading ability to rapidly set up well-designed clinical trials can deliver the evidence needed to optimise medical interventions and save lives in the pandemic.”