This year there are no genuine major trial presented 2018 at the meeting, Instead, there are many real world diabetes observational studies.
Randomized controlled clinical trial (RCT) are the gold standard för establishing safety and efficacy of new diabetes treatments. But real world observations can add important information that RCT may not fully provide.
These studies can give informations about the effectiveness of a medication beyond the strict definitions of a tightly controlled and monitored trial population, give information in the broader population receiving real care in real care clinical practices. That´s Life Science.
Real word studies generally include a greater mix and variety of patients than RCT. There are more likely to be more older adults as well as a greater ethnic and racial diversity. These patients present a more varied mix of patient histories, comorbidities, adherence patterns, and other v ariables. These studies can also address questions that may be impractical to explore in the RCT setting.
The limitations is that there could be more risk for confounding factors that could influence the study results.For example, the reasons for the choice of different therapies are frequently not fully available, which can result in selection bias. A number of statistical methods can bu used to try to address these limitatiuons in the real word studies to optimize them.
Combining RCT with the real word studies will provide with complimentary information that can be valuable to regulatory authorities for re-imbursement and particularly for clinicians seeing patients in everyday practice
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