| Summary: | A clinical trial is commonly defined as a human experiment that has the potential to
improve the quality of health care. It is also an argument. In the realm of medical
investigations, a clinical trial is classified as an experimental analytic study because it
can be designed and implemented in a manner that allows investigators to argue on the
basis of objective, unbiased evidence. Currently, there is a need for such evidence by
medical decision-makers. The scientific basis of this 'evidence-based medicine' relies
upon clinical trials, in particular, randomised controlled trials (RCTs). These trials are
regarded as the most reliable trials for evaluating treatments. However, the best
available evidence is usually something less than a RCT. Between the years of 1993
and 1997, I assisted in the design and implementation of six clinical trials. I wanted to
evaluate the quality of my trials, but I realised that many scales and checklists available
were only concerned with assessing a trial's design and analysis. Little consideration
was made about a trial's implementation. Thus, based on my intimate knowledge of
clinical trials, I developed a Clinical Trial Evaluation System (CTES) that allowed me to
assess the amount my trials, or any clinical trial, deviated from a randomised controlled
trial done according to "Good Clinical Practices". The evaluation involved determining
whether or not items relevant to the trial's question, design, statistics, ethics, and
standard operating procedures were considered. For each of my trials, I derived a
clinical trial score that I then turned into a % deviation from the best possible trial. All of
the trials deviated for many reasons. The strengths of CTES are the assessment of a
trial's quality following its completion, the comparison of trial scores and % deviations,
the determination of deviation patterns within and amongst trials, and the explanations
for why deviations occurred from the best possible trial. Another strength is the better
planning of subsequent clinical trials. Future developments of the system will involve
the refinement of CTES, the determination of interrater reliability, the estimation of time
for completion, and the creation of relational database for evaluating and planning
clinical trial protocols. I believe that students, clinicians, and evidence-based medicine
organisations can optimise the quality of their trials by using the Clinical Trial Evaluation
System.
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