The American Journal of Medicine
Volume 122, Issue 2 , Pages 114-120, February 2009

From Randomized Controlled Trials to Observational Studies

  • Stuart L. Silverman, MD

      Affiliations

    • Corresponding Author InformationRequests for reprints should be addressed to Stuart L. Silverman, MD, Clinical Professor of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine UCLA, OMC Clinical Research Center, 8641 Wilshire Blvd. Suite 301, Beverly Hills, CA 90211

Clinical Professor of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine UCLA, OMC Clinical Research Center, Beverly Hills, Calif

Abstract 

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Keywords: Health care databases, Observational studies, Osteoporosis, Randomized controlled trials, Treatment effectiveness

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 Funding: The author received editorial support in the preparation of this manuscript funded by The Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and sanofi-aventis U.S., Inc). The author, however, was fully responsible for all content and editorial decisions and received no financial support or other form of compensation related to the development of the article.

 Conflict of interest: The author is a consultant and speaker for The Alliance for Better Bone Health and has received research grant support.

 Authorship: The author had access to the data and maintained complete control of manuscript development.

PII: S0002-9343(08)00952-2

doi:10.1016/j.amjmed.2008.09.030

The American Journal of Medicine
Volume 122, Issue 2 , Pages 114-120, February 2009

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