Featured Research

from universities, journals, and other organizations

New drugs should be compared with existing treatments before approval, say experts

Date:
September 6, 2011
Source:
BMJ-British Medical Journal
Summary:
Manufacturers should have to show how their drugs compare to existing treatments before approval to help ensure that the most beneficial and safest therapies reach patients and that limited healthcare resources are invested wisely, argue experts in a new article.

Manufacturers should have to show how their drugs compare to existing treatments before approval to help ensure that the most beneficial and safest therapies reach patients and that limited healthcare resources are invested wisely, argue experts in an article in the British Medical Journal online.

Related Articles


Currently, manufacturers have to compare the risks and benefits of a new drug against a placebo. Direct (head to head) comparisons with existing therapies are only required when use of a placebo is deemed unethical.

This, argue researchers at the London School of Economics and European Observatory on Health Systems and Policies, does not allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives.

This can result in "the widespread use of potentially less efficacious and unsafe drugs," they warn. A number of studies have also questioned the true added value offered by new (and often more expensive) drugs compared with existing treatments.

The European Medicines Agency (EMA) has long encouraged that, when possible, pre-market studies should be undertaken to establish comparative efficacy and risk, but has yet to set comparative assessments as the default evidentiary standard for market approval, write the authors. Rather, requirements for comparative studies are made on a case by case basis.

While estimates suggest that comparative efficacy data are available for 50-70% of new molecular entities at the time of approval, the authors argue that this varies across therapeutic areas and that only a fraction of evidence is often accessible at the time of market authorisation.

A further challenge is that no particular type of study is ideal for assessing comparative efficacy, they add.

Despite these limitations, they believe that "comparative efficacy evidence should have a formal role in drug licensing decisions."

They call for open dialogue between regulators, manufacturers and government agencies "to achieve better congruence between licensing and reimbursement requirements" and better public access to comparative data on the effectiveness and safety of new drugs.

"Numerous promising medicines have been developed and many more are on the way to initial clinical trials," say the authors. "With this success comes an equally important additional need -- to develop a systematic approach to evaluate the risks and benefits of these new therapies in the context of existing alternatives. An important initial step is to support a formal role for comparative efficacy evidence in drug licensing," they conclude.


Story Source:

The above story is based on materials provided by BMJ-British Medical Journal. Note: Materials may be edited for content and length.


Journal Reference:

  1. C. Sorenson, H. Naci, J. Cylus, E. Mossialos. Evidence of comparative efficacy should have a formal role in European drug approvals. BMJ, 2011; 343 (sep06 1): d4849 DOI: 10.1136/bmj.d4849

Cite This Page:

BMJ-British Medical Journal. "New drugs should be compared with existing treatments before approval, say experts." ScienceDaily. ScienceDaily, 6 September 2011. <www.sciencedaily.com/releases/2011/09/110906191638.htm>.
BMJ-British Medical Journal. (2011, September 6). New drugs should be compared with existing treatments before approval, say experts. ScienceDaily. Retrieved November 27, 2014 from www.sciencedaily.com/releases/2011/09/110906191638.htm
BMJ-British Medical Journal. "New drugs should be compared with existing treatments before approval, say experts." ScienceDaily. www.sciencedaily.com/releases/2011/09/110906191638.htm (accessed November 27, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Thursday, November 27, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Pet Dogs to Be Used in Anti-Ageing Trial

Pet Dogs to Be Used in Anti-Ageing Trial

Reuters - Innovations Video Online (Nov. 26, 2014) Researchers in the United States are preparing to discover whether a drug commonly used in human organ transplants can extend the lifespan and health quality of pet dogs. Video provided by Reuters
Powered by NewsLook.com
Today's Prostheses Are More Capable Than Ever

Today's Prostheses Are More Capable Than Ever

Newsy (Nov. 26, 2014) Advances in prosthetics are making replacement body parts stronger and more lifelike than they’ve ever been. Video provided by Newsy
Powered by NewsLook.com
From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

From Popcorn To Vending Snacks: FDA Ups Calorie Count Rules

Newsy (Nov. 25, 2014) The US FDA is announcing new calorie rules on Tuesday that will require everywhere from theaters to vending machines to include calorie counts. Video provided by Newsy
Powered by NewsLook.com
Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Daily Serving Of Yogurt Could Reduce Risk Of Type 2 Diabetes

Newsy (Nov. 25, 2014) Need another reason to eat yogurt every day? Researchers now say it could reduce a person's risk of developing type 2 diabetes. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins