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International Clinical Trials

Reality Check

Randomised controlled trials (RCTs) are the gold standard for drug approval to establish the efficacy of interventions, and pragmatic RCTs measure their effectiveness. Real world studies are referring to pragmatic RCTs for the purpose of this article.

In recent years, the UK has seen a shift in the NHS treatment of patients with ongoing chronic medical conditions from secondary to primary care. The NHS Constitution has promised that all eligible prospective participants are offered the choice and opportunity to take part in relevant studies (1). Therefore, in order to cultivate these developments and truly represent the study population, there needs to be a move away from traditional research studies that extrapolate results in other settings, to real world evidence obtained from patients in both secondary and primary care. This is because it could be argued that patients who attend research facilities are in an ‘artificial’ controlled environment, rather than reflecting real life clinical practice. Often, with traditional RCTs, many subjects have a single disorder under examination – meaning those with several co-morbidities are excluded and results can only be true in those with solitary disease profiles.

Real World Studies

This is where real world studies can prove invaluable. They are able to combat the above issues, plus complement the established phases of trial methodology by widening the inclusion criteria to include subjects with several comorbidities – thus allowing closer examination of real life subjects as opposed to generalisation of a population. Conversely, the data available in primary care are comprehensive, and strict selection of data values is necessary to avoid any unethical collection of data that would be discounted at the analysis stage.

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Julie Millar is CK Aspire’s Community Research Nurse Team Lead. Prior to this role, she worked in the NHS in Renal Medicine and as a Community Practice Nurse specialising in respiratory. Julie holds a Bachelor’s in Specialist Practitioner/ Practice Nursing.

Gaynor Mates is currently employed as a Clinical Research Nurse for CK Aspire, working on a real world study. Before joining the company, she worked with the NHS for 30 years, the last 17 of which she spent as a Lead Respiratory Nurse Specialist. Gaynor holds an MSc and a BSc in Respiratory Disease Management and is an Independent Nurse Prescriber.

Louise Doyle
is Senior Research Safety Officer at CK Aspire. Having qualified as a Midwife in 2008, she has worked as a researcher in maternity, infection control, paediatric oncology and respiratory studies. Louise holds a Postgraduate Diploma in Clinical Research.

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Julie Millar
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Gaynor Mates
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Louise Doyle
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