MedicineWorld.Org
Your gateway to the world of medicine
Home
News
Cancer News
About Us
Cancer
Health Professionals
Patients and public
Contact Us
Disclaimer

Medicineworld.org: Half of trials supporting FDA applications go unpublished

Back to research news Blogs list Cancer blog  


Subscribe To Research News RSS Feed  RSS content feed What is RSS feed?

Half of trials supporting FDA applications go unpublished




Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine The most important trials determining efficacy, and those with statistically significant results and larger sample sizes, are more likely would be published.



Half of trials supporting FDA applications go unpublished

Ida Sim and his colleagues from the University of California San Francisco searched the medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug approval applications approved by the US Food and Drug Administration (FDA) between 1998 and 2000. Eventhough 76% of the pivotal trials (typically large Phase II or III trials designed to provide evidence on the overall risks and benefits of a drug) had been published in medical journalscommonly within 3 years of FDA approvalonly 43% of all of the submitted trials had been published.

The scientists also found evidence of selective reporting of the results from these trials. For example, Sim and his colleagues report that a pivotal trial in which a new drug works better than an old drug is more likely would be published than a trial in which the new drug does no better. This is a form of publication bias that may lead to an inappropriately favorable record in the medical literature of a drug's true risk-benefit profile relative to other standard therapies, and can lead to preferential prescribing of newer and more-expensive therapys, say the authors.

These new results provide a baseline for monitoring the effects of the FDA Amendments Act 2007, which was introduced to improve the accuracy and completeness of drug trial reporting. Under this Act, all trials supporting FDA-approved drugs must be registered when they start and the results of all the outcomes declared at trial registration as well as specific details about the trial protocol must be publicly posted within a year of drug approval on the US National Institutes of Health clinical trials.gov site.


Posted by: Scott    Source




Did you know?
Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine The most important trials determining efficacy, and those with statistically significant results and larger sample sizes, are more likely would be published.

Medicineworld.org: Half of trials supporting FDA applications go unpublished

Acute bacterial meningitis| Alzheimer's disease| Carpal tunnel syndrome| Cerebral aneurysms| Cerebral palsy| Chronic fatigue syndrome| Cluster headache| Dementia| Epilepsy seizure disorders| Febrile seizures| Guillain barre syndrome| Head injury| Hydrocephalus| Neurology| Insomnia| Low backache| Mental retardation| Migraine headaches| Multiple sclerosis| Myasthenia gravis| Neurological manifestations of aids| Parkinsonism parkinson's disease| Personality disorders| Sleep disorders insomnia| Syncope| Trigeminal neuralgia| Vertigo|

Copyright statement
The contents of this web page are protected. Legal action may follow for reproduction of materials without permission.