Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer
Executive SummaryEmerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
You may also be interested in...
US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.
Pfizer's Esther Avila says it will take a collaborative effort between industry and drug regulators across Latin America to spur adoption of real-world evidence in the region.