Clinical trials are conducted for the purpose of collecting data on the efficacy of medical treatments. The treatment might be, for example, a new
drug, a
medical device, a
surgical procedure, or a preventative regime. but typically, in a controlled trial, researchers gather a group of volunteers and subject some to the test treatment, while giving the others either no treatment (known as a
placebo) or an established treatment for comparison. After a defined time period, the patients in the test group are assessed for health improvements in comparison with the
control group. However, trials can vary greatly in quality. Methodological errors such as poor
blinding or poor
randomisation allow factors such as the
placebo effect or
selection bias to adversely affect the results of a trial.
Randomisation Randomisation is a process to remove potential distortion of statistical results arising from the manner in which the trial is conducted, in particular in the selection of subjects. Studies have indicated, for example, that nonrandomised trials are more likely to show a positive result for a new treatment than for an established conventional one. The
placebo effect is known to be a confounding factor in trials; affecting the ability of both patients and doctors to report accurately on the clinical outcome.
Experimental blinding is a process to prevent
bias, both conscious and subconscious, skewing results. Blinding should be appropriate to the study, and is ideally
double blind, wherein neither the patient nor doctor is aware of whether they are in the control or test group, eliminating any such psychological effects from the study.
Withdrawals and dropouts Withdrawals and
dropouts are those patients who fail to complete a course of treatment, or fail to report back on its outcome to the researchers. The reasons for doing so might be varied: the individuals may have moved away, abandoned the course of treatment, or died. Whatever the reason, the attrition rate can skew results of a study, particularly for those subjects who ceased treatment due to perceived inefficacy. In
smoking cessation studies, for example, it is routine to consider all dropouts as failures. ==Jadad questionnaire==