Navigation Links
Studies for approval of new drugs have insufficient patients to evaluate safety
Date:3/19/2013

For medicines intended for chronic use, the number of patients studied before regulatory approval is insufficient to properly evaluate safety and long-term efficacy, requiring the need for new legislation, according to a study by European researchers published in this week's PLOS Medicine.

Current European guidelines specify that in order to fully evaluate the safety of medicines being developed for chronic (long-term) treatment of non-life threatening diseases, at least 1000 patients must take the new drug and that 300 and 100 patients must use the drug for 6 and 12 months, respectively, before approval by the European Medicines Agency.

In an analysis led by Ruben Duijnhoven from Utrecht University, the authors used information from the European Commission about 200 medicines approved between 2000 and 2010 to investigate whether the number of patients included were in compliance with the International Conference on Harmonisation E1 guidelines.

The authors found that the average number of patients studied before approval was 1708 for standard medicines and 438 for orphan medicines, medicines used to treat rare diseases. On average, medicines for chronic use (for example, asthma medications) were studied in more patients (2338) than those for intermediate use such as anti-cancer drugs (878) or short-term use such as antibiotics (1315). The safety and efficacy of chronic use was studied in fewer than 1000 patients for at least 6 and 12 months in 46.4% and 58.3% of new medicines, respectively. Finally, the authors found that among the 84 medicines intended for chronic use, 69 were studied in at least 300 patients for 6 months and 67 were studied in at least 100 patients for 12 months.

The authors say: "For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy. Both safety and efficacy require continued study after approval."

They conclude: "In light of new scientific and legislative tools to monitor benefits and risks in clinical use, discussion of the long-term exposure requirements for approval of medicines, particularly for medicines intended for chronic use, seems warranted."

The authors add: "Such a discussion should involve healthcare providers, patients, and academia, as well as industry and regulators, and should include debate on the level of acceptable uncertainty, especially for adverse events and the long-term outcomes for chronic medication."


'/>"/>

Contact: Sumrina Yousufzai
syousufzai@plos.org
415-568-3164
Public Library of Science
Source:Eurekalert

Related medicine news :

1. First targeted nanomedicine to enter human clinical studies
2. Joint-Replacement Failure Rate Higher for Smokers: Studies
3. IADR/AADR publish studies on severe early childhood caries - proposes new classification
4. ASCO releases studies from upcoming annual meeting
5. University studies and career expectations of medical students
6. Studies See Advances in Detecting, Treating Pancreatic Cancer
7. IU bisexuality studies focus on health, behavior and identity
8. The REMARK checklist explained: How to use guidelines on reporting tumor marker prognostic studies
9. New Drug Effective for Rare Genetic Skin Cancer: Studies
10. 2 new studies show connection between sleepiness and pro-athlete careers
11. No Cancer Risk From Long-Acting Insulin: Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/25/2017)... Indianapolis, IN (PRWEB) , ... April 25, 2017 ... ... Washington, D.C., CEOs, CFOs and HR decision-makers are preparing for how his administration ... Life Financial will provide insight into what changes are most likely to make ...
(Date:4/25/2017)... ... April 25, 2017 , ... Patients who would like ... in a fraction of the time as traditional braces – Wilckodontics®. Dr. Victoria ... now offers this revolutionary treatment with or without a referral. , Wilckodontics ...
(Date:4/25/2017)... ... April 25, 2017 , ... Buyers and sellers in ... to dispensaries and head shops –can’t help but be heartened by the industry’s current ... cannabis odor aptly described as “skunk smell.” At last they can simply, safely ...
(Date:4/25/2017)... ... 25, 2017 , ... There is no better place in South Florida to ... in the May issue of Consumer Reports focused on heart health. , The ... during and after coronary bypass and aortic valve replacement procedures. , Consumer Reports ...
(Date:4/24/2017)... ORLANDO, FLORIDA (PRWEB) , ... April 24, 2017 ... ... of telehealth technology yesterday, featuring Bring Your Own Device (BYOD) capabilities at Telehealth ... compliment LG CNS’ pre-packaged telehealth bundles, which pairs medical devices with a pre-programmed ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 2017  RXi Pharmaceuticals Corporation (NASDAQ: RXII), a ... significant unmet medical needs, today announced that it ... product development program, based on its proprietary self-delivering ... Dermatology (SID) 76 th Annual Meeting.  The ... sciences relevant to skin health and disease through ...
(Date:4/20/2017)... 2017 Research and Markets has announced ... Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive ... offering. ... market was valued at US$ 7,167.6 Mn in 2015, and ... at a CAGR of 5.6% from 2016 to 2024. ...
(Date:4/19/2017)... NEW YORK , April 19, 2017 Cardiology ... during the projected period The Cardiology Devices segment ... more than US$ 15 Mn in 2018 over 2017. By ... reach a market valuation close to US$ 700 Mn, expanding ... Cardiology Devices segment dominated the Asia Pacific ...
Breaking Medicine Technology: