Evaluating the quality of clinical trials using a Clinical Trial Evaluation System (CTES)

• Main Author: Franciosi, Luigi Giuseppe
• Language: English
• Published: 2009
• Online Access: http://hdl.handle.net/2429/7669

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.