[Strategies avoiding inertia and non compliance in clinical trials].
Randomised controlled trials play a key role in evidence-based medicine as far as the assessment of both efficacy and safety of drugs is concerned. Various strategies are used to avoid physician's inertia and to combat patient's non compliance, two pitfalls that may hinder the demonstration of the therapeutic efficacy of the drug. Clinical inertia may be limited by titration, forced or optional, driven by therapeutic targets, or by the use, if necessary, of rescue medications. Compliance may be verified by "pill count". This simple technique allows to exclude non compliant patients when they are detected during the placebo run-in period before randomisation or not to take into account patients with poor compliance in the final evaluation by using a statistical analysis restricted to individuals who have strictly adhered to the study protocol ("per protocol analysis"). Self-monitoring and patient's empowerment in the treatment also contribute to improve drug compliance. Clinicians may take advantage of these approaches derived from clinical trials to improve their daily practice.
Jandrain
B J
BJ
Unité de Pharmacologie clinique (ATC), CHU de Liège, Belgique.
Ernest
Ph
P
Radermecker
R P
RP
Scheen
A J
AJ
D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D010349:Patient Compliance