View Entire Collection
By Clinical Topic
Diabetes – Summer 2012
Future of Nursing Initiative
Heart Failure - Fall 2011
Influenza - Winter 2011
Nursing Ethics - Fall 2011
Trauma - Fall 2010
Traumatic Brain Injury - Fall 2010
Fluids & Electrolytes
WEDNESDAY, Sept. 7 (HealthDay News) -- New drugs should be compared with existing treatments instead of placebo before their approval in Europe, according to a report published online Sept. 6 in the BMJ.
Corinna Sorenson, M.P.H., M.H.S.A., from the London School of Economics and Political Science, and colleagues discussed the current requirements, availability, and methodological tools for comparative efficacy evidence in Europe for the approval of new drugs.
The authors reported that the current European policy of comparing the benefits and risks of a new drug against a placebo (with comparisons with existing therapies required only when placebo use is deemed unethical), does not allow health care decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives. The availability of comparative efficacy varies across therapeutic areas, and only a fraction of evidence is accessible at market authorization. The European Medicines Agency (EMA) encourages pre-market studies to establish comparative efficacy and risk, but has not made it a compulsory evidentiary standard for market approval. The EMA recommends randomized controlled trials for new drugs with safety or inferiority concerns. The authors suggest non-inferiority studies when alternative treatment options exist. They recommend open dialogue and agreement between the EMA, manufacturers, payers, and governments on the licensing and reimbursement requirements, and suggest that data on the efficacy, effectiveness, and safety of new drugs should be made publically available.
"Comparative efficacy evidence should have a formal role in drug licensing decisions," the authors write.
Full Text (subscription or payment may be required)
Sign up for our free enewsletters to stay up-to-date in your area of practice - or take a look at an archive of prior issues
Join our CESaver program to earn up to 100 contact hours for only $34.95
Explore a world of online resources
Back to Top