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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.

Opportunities for the use of routinely collected data for the generation of large randomized evidence in Colombia