Evidence-based medicine is central to modern medical practice and relies on the availability of data from appropriately conducted randomized clinical trials (RCTs). These studies establish whether treatment is effective and, when an active comparator group is included in the trial, whether the new therapy is better than currently used treatment. In some conditions such as chronic obstructive pulmonary disease (COPD) for which no single surrogate end point predicts response to treatment, multiple trials of varying duration are needed to convince physicians and regulators that drug therapy is beneficial. The mainstays of COPD management, including inhaled long-acting antimuscarinic agents or long-acting β-agonists (LABAs) alone or combined with inhaled corticosteroids (ICSs), have been shown in RCTs to improve lung function and quality of life and reduce exacerbation frequency.1-3 Patients included in these trials are selected on the basis of having stable COPD without serious diseases that would lead to premature death, and these studies are then incorporated into treatment guidelines that direct clinical practice.4
Calverley PMA. Treating COPD in the Real World. JAMA. 2014;312(11):1101–1102. doi:https://doi.org/10.1001/jama.2014.11322
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