Most discontinued trials remain unpublished


Clinical Trials (journal)
Clinical Trials (journal) (Photo credit: Wikipedia)

Source: All Trials

 

A new research paper in JAMA looking at 1017 clinical trials has found that most trials stopped before the planned end remain unpublished, and overall 56% never published results. An international research group was given access to the records of all the clinical trials approved by six ethics committees in Switzerland, Germany and Canada between 2000 and 2003. They searched for journal articles written about these trials and found only 567 papers, so only 56% of the trials had results published in a journal.

The researchers found that 25% of the trials were ended earlier than planned, primarily due to problems recruiting volunteers. Around 60% of those trials had not been published. The researchers identified nine trials that were stopped because it became clear that the treatment had a beneficial effect – all of these trials were subsequently published as journal articles.

The researchers conclude: “The non-publication of results from discontinued—or from completed—[clinical trials] represents a waste of valid data that could contribute to systematic reviews and meta-analyses.”

Prevalence, Characteristics, and Publication of Discontinued Randomized Trials JAMA.2014;311(10):1045-1052. doi:10.1001/jama.2014.1361 http://jama.jamanetwork.com/article.aspx?articleid=1840235

Safety Patients: Olmesartan


  • Fda
    Fda (Photo credit: Wikipedia)

    Olmesartan: Drug Safety Communication – FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive

    Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics

    AUDIENCE: Cardiology, Pharmacy, Family Practice, Endocrinology

    ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.

    BACKGROUND: FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.