Is there another way to take account of noncompliance in randomized controlled trials?

Catherine E. Hewitt; David J. Torgerson; Jeremy N.V. Miles

doi:10.1503/cmaj.051625

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The challenges of randomized control trials.
Jeevan P Marasinghe

Posted on: 22 August 2006

Posted on: (22 August 2006)
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The challenges of randomized control trials.
Jeevan P Marasinghe
Randomized control trials (RCT) are considered as the most optimal, powerful and indispensable methods for therapeutic innovations. Hewitt C.E et al (1) have excelled in giving a brief account on the effect of non compliance in RCT and the effect of it at the analysis stage. We would like to add few more points to make it more complete.
Non compliance can seriously decrease the study power (2) resulting in widel...
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Randomized control trials (RCT) are considered as the most optimal, powerful and indispensable methods for therapeutic innovations. Hewitt C.E et al (1) have excelled in giving a brief account on the effect of non compliance in RCT and the effect of it at the analysis stage. We would like to add few more points to make it more complete.
Non compliance can seriously decrease the study power (2) resulting in widely varying estimates of the required sample size (3).This makes non compliance a significant issue when planning trials with long term treatments. More over the results of on-treatment analysis can be biased in situations where participants decline treatment because they can not afford the expenses of drugs unless they are freely issued (4).Incorporation of patient preferences into randomization process will have the same effect (5).These have generated considerable ground clearance work of ethical conflicts in carrying out RCT.
With these dilemmas of practicability, it may be an interesting exercise to compare the results of well designed observational studies with those of RCT.
Jeevan P Marasinghe, Registrar in Professorial Obstetrics and Gynecology unit, Faculty of Medicine, University of Peradeniya, Sri Lanka.
A.A.W.Amarasinghe MD,Consultant Psychiatrist,Mcdonough,Georgia,USA.
References.
(1)Catherine E .Hewitt, David J Torgerson and Jeremy N.V.Miles.Is there another way to take account of noncompliance in randomized controlled trials? CMAJ August 15 2006; 175(4).
(2)Snapinn SM,Jiang Q,Iqlewicz B. Informative noncompliance in endpoint trials.Curr Control Trials Cardiovasc Med.2004 Jul 3;5(1):5.
(3)Freedman LS.The effect of partial noncompliance on the power of a clinical trial.Control Clin Trials.1990 Jun; 11(3):157-68.
(4)HA de Silva, A Pathmeswaran and SB Gunatilake.Efficacy of rivastigmine on activities of daily living in Sri Lankan Patients with Alzheimer disease and on improving caregiver burden: a prospective study. The Ceylon Medical Journal Sept 2005, Vol 50, No.3, 106-109.
(5)Lambert MF,Wood J. Incorporating patient preferences into randomized trials.J Clin Epidemiol.200 Feb;53(2):163-6.
Conflict of Interest:
None declared
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Competing Interests: None declared.