Clinical pharmacologists can support the recovery of, and advance, non-COVID-19 research through innovative digital trials. This will help to not only widen participation in trials, but also enable quicker and more cost-effective recruitment, leveraging the huge benefits of the NHS at both primary and secondary care levels.
Clinical pharmacologist, Professor Tom MacDonald, has supported the recovery of non-COVID-19 research through innovative digital trials - for example on Pragmatic Randomised Open Blinded Endpoint (PROBE) trials[1] , including some, like the Treatment in Morning versus Evening (TIME) study[2] , that have involved patient recruitment and data collection entirely online. Clinical Pharmacologists can advise on appropriateness and likely validity of trials conducted outside clinical settings, such as at home or via roving clinics.
Innovations like this have huge potential to decentralise trials and engage patients with research that is relevant to them[3] .
Investment in data, and data interoperability is needed to realise the potential of patient data across the NHS and research pathway. Clinical pharmacologists can advise on data priorities and strategy. Working with Health Data Research-UK (HDR-UK) and Office for National Statistics (ONS), and with approval of the Government Office of Science, Professor Sir Munir Pirmohamed has also been leading the development of the data infrastructure require to undertake research following the roll-out of vaccines. This has included developing data linkages needed to ensure vaccines data at the point of vaccination, as well as data from hospitals are available for research purposes in a timely manner. Investment in clinical pharmacology and a broader data skills base will support this work and broader applications of it in the future. A data strategy for medicines more broadly will enable support for all aspects of drug discovery, cost-effective delivery as well as supporting regulation and linked pharmacovigilance to create an agile mechanism for the safe use of medicines in society.
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References
- Mackenzie IS, Ford I, Nuki G, Hallas J, Hawkey CJ, Webster J, Ralston SH, Walters M, Robertson M, De Caterina R, Findlay E, Perez-Ruiz F, McMurray JJV, MacDonald TM; FAST Study Group. (2020) Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial. Lancet. Nov 28;396(10264):1745-1757.
- Rorie DA, Rogers A, Mackenzie IS, Ford I, Webb DJ, Willams B, Brown M, Poulter N, Findlay E, Saywood W, MacDonald TM (2016) Methods of a large prospective, randomised, open-label, blinded end-point study comparing morning versus evening dosing in hypertensive patients: the Treatment In Morning versus Evening (TIME) study. BMJ Open. Feb 9;6(2):e010313.
- European Pharmaceutical Review (2020) How will clinical trials change in light of COVID-19?