18 Feb The Importance of Real-World Evidence in Medical Research and Drug Development

By Manfred Stapff, Applied Clinical Trials

As the gold standard for clinical research, randomized controlled trials (RCTs) are central to scientific knowledge gain and evidence generation as they are meticulously designed to eliminate bias, providing clear, impartial results on the effectiveness of medical interventions. However, critiques often revolve around the challenges of applying findings from highly controlled trial environments to the general population.

People who are included in clinical trials are, in general, predominantly male, younger, white, and seem to have a higher socio-economic status than the respective population having the disease in question. Also, children, juveniles, elderly, and pregnant or breastfeeding women are often excluded, though this is done intentionally for safety reasons. Moreover, the conditions of a trial typically do not perfectly mirror real-world conditions, in which patient behaviors and environments vary significantly. This discrepancy can lead to significant challenges when trying to apply trial findings universally. Read more…