Revolutionizing clinical trials

Randomized clinical trials (RCTs) have represented, for a long time, the gold standard for clinical trials and the fundamental basis for attaining US Food and Drug Administration approval. However, the major players in health markets are no longer satisfied with meeting safety and efficacy requirements, but are also seeking treatments with better real world effectiveness, comments Dr Nicola Davies in her monthly exclusive for The Pharma Letter.

In an article for Clinical Trial Arena, Nigel Hughes, director of Integrative Healthcare Informatics at Janssen R&D, wrote that we are likely to see “unprecedented transformations in how we conduct RCTs and allied studies” in the 21st Century. Indeed, new medical testing regimes that reflect more naturalistic outcomes are gaining considerable favour from patients, clinicians, payers and regulators.

The problem with RCTs