Abstract
Randomized clinical trials are the cornerstone design for the evaluation of the safety and efficacy of health interventions. Furthermore, morbidity and mortality rates could be reduced if evidence of better interventions is sought and used to inform medical practice. However, only small to moderate, yet worthwhile, effects can be expected from such interventions. Therefore, moderate random error and moderate biases must be avoided during the design, conduct and analysis of trials. Routinely collected data, such as vital statistics, hospital episode statistics and surveillance data, could be used to enhance recruitment and follow-up a large number of patients, reducing both random error and moderate biases. Here, we discuss the opportunities and challenges for the use of these data for clinical studies in Colombia.
Highlights
Over the last two centuries life expectancy has improved remarkably, rising from less than 50 years in the 19th century to more than 70 years in 20101,2
If only small to moderate effects can be expected from health interventions, moderate random error and biases must be avoided during the design, conduct and analysis of clinical trials4,14
The use of routinely collected healthcare data (RCHD) in the planning and conduct of clinical trials may increase the recruitment of participants and reduce the time required to achieve the sample size, since using RCHD is an efficient method for selecting study sites and identifying potential trial participants meeting eligibility criteria
Summary
Over the last two centuries life expectancy has improved remarkably, rising from less than 50 years in the 19th century to more than 70 years in 20101,2. If only small to moderate effects can be expected from health interventions, moderate random error and biases must be avoided during the design, conduct and analysis of clinical trials. The randomization of a large number of participants in controlled clinical trials reduces both random error and biases15 Both large observational studies and small randomized clinical trials may produce chance or biased results, hindering the implementation of health interventions in clinical practice. Moderate random error and biases may produce chance findings or increase the effect size of futile interventions; for example, a meta-analysis of small clinical trials of magnesium sulphate versus placebo suggested a reduction of about a half in the odds of death (odds ratio [OR] 0.45, p
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