Journal of the Korean Society of Hypertension  2011;17(1):1-9

doi:10.5646/jksh.2011.17.1.1

The Appropriate Interpretation of Recent Clinical Trials: How to Read RCT in the Era of Advertizing-based Medicine.

Iwao KUWAJIMA 1

Affiliations

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Keywords

Evidence-based medicine; Prospective randomized open labeled blinded endpoint; Randomized controlled trials; Post-hoc analyses; Angiotensin receptor blocker

Country

Republic of Korea

Language

English

Abstract

Although evidence-based medicine (EBM) has changed medical therapy from experience- or experiment-based medicine to the modern science-based medicine, nowadays it seems to be used as a tool of advertizing strategy of industries. Clinical trial is a fundamental component of EBM and it costs very much and are mostly conducted by the financial support of pharmaceutical industries at a tremendous expense. If anticipated results for the sponsor were not shown in the trial, a "spin" has been used to mislead readers as if positive results for test drugs or devices were obtained by emphasizing subgroup analysis, or searching favorable endpoint by post-hoc analysis. Clinical trials on angiotensin receptor blocker (ARB) are continuing succession of defeat all over world except two Japanese clinical trials, JIKEI HEART and KYOTO HEART studies. However, in both trials, subjective soft endpoints, such as angina pectoris or congestive heart failure were used despite of prospective randomized, open labeled, blinded endpoint design. In the era of advertizing-based medicine, It is important to read clinical trial data with critical view points.