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Clinical Trials: Time for a Paradigm Shift?

Submitted by on January 18, 2014 – 7:01 PM
cartoon2Clinical trials are considered to be the most rigorous form of evidence and form the essence of the current evidence based health care. Given the randomized and double blinded nature of the most stringent of these studies, clinical trials are the ones least subjected to bias. A great deal of effort is put in patient selection to avoid the selection bias. Attempts are also undertaken to ensure that the compliance is kept at maximum, drop out rates can be kept at minimum and the population follows up at pre-specified intervals.


With this brief overview in our mind, it would be prudent to assume that the findings from clinical trials can be used to guide the clinical practice. Simply put, the more rigorous a trial, the more likely it should be to generalize its findings. While this sounds doable and indeed has been a norm for decades, it now appears that it’s easier said than done. In other words, despite the high quality of these studies, it’s often not possible to translate the findings of clinical trials into actual clinical practice.


The reason is simple; real world practice differs from the tight confines of the world of clinical trials. The compliance is likely to be much lower in the real world, the follow ups likely to be heterogenous, patient selection less strict and so on. Lets consider an example of DASH (Dietary Approaches to Stop Hypertension) study, an extremely well conducted clinical trial involving dietary intervention. The study established that a diet rich in fruits and vegetables and low in fat can substantially lower blood pressure.


Despite the fact that more than one and a half decades have past since the publication of DASH study, clinicians still have a hard time convincing the patients about the deleterious effects of certain dietary practices. Thus, the focus is now on conducting clinical trials in a more pragmatic manner (pragmatic trials) so that the findings could be generalizable across a much wider population. Indeed, the future may belong to pragmatic trials!



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