Salford Lung Study
Ten years on, the pioneering Salford Lung Study continues to influence modern thinking for real-world evidence and pre-market approval of pragmatic clinical trial design.
GlaxoSmithKline plc (GSK), the industry sponsor of the Salford Lung Study (SLS), took the bold decision to pilot a new trial model.
In a ground-breaking move, the company compared the effectiveness and safety profile of initiating asthma and chronic obstructive pulmonary disease (COPD) treatments in a trial that used a diverse, real-world patient cohort, carried out in an everyday primary care setting.
The benefit of this new trial design was that it enabled typically excluded patients to take part in the trial, such as the elderly and people who smoke, for example. By allowing a diverse patient population in a real-world setting, higher volumes of safety events were anticipated than a routine RCT, therefore safety technology that had never been used before to generate safety alerts in near real time, allowing a rapid response was used.
The comprehensive and accurate data generated allowed GSK to identify safety signals more quickly than in a traditional trial, with important risk-benefit analysis data made available for regulatory submission.
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