Health and Medical News and Resources

General interest items edited by Janice Flahiff

Many NIH-funded clinical trials go unpublished over two years after completion (with ClinicalTrials.gov link for many trial study results)

[Flahiff’s note:  It is possible that  many of these unpublished clinical trial results would have made a positive difference in many people’s lives. These unpublished results have the potential of aiding many researchers. They can prevent unnecessary duplicate trials, point to areas needing more research, and potentially provide groundwork for collaboration.

On another note, it is good to see that published research papers are now more accessible to all.  As of 2008, research papers based on NIH grants must be submitted to PubMed Central (PMC) when those papers are accepted for publication in a peer-reviewed journal. PMC will then make the papers freely available to the public within 12 months of publication.

I look forward to the day when all research papers are freely available to the public.  There are a myriad of issues, as who pays for the publishing, the peer review process, and where the research papers should be “housed”. However, I believe the more scientific research results are disseminated in easily accessible format, the more we can advance in technology applications and filling in knowledge gaps.]

Excerpt from the 3 January 2012 article By Karen N. Peart at Yale News

In a study that investigates the challenges of disseminating clinical research findings in peer-reviewed biomedical journals, Yale School of Medicine researchers have found that fewer than half of a sample of trials primarily or partially funded by the National Institutes of Health (NIH) were published within 30 months of completing the clinical trial.

These findings appear in the January issue of the British Medical Journal, which focuses on the topic of unpublished evidence.

[As of 3 January 2012, the January issue of BMJ was not yet online..however many of the articles may be found at http://www.bmj.com/archive/sevendays]

“When research findings are not disseminated, the scientific process is disrupted and leads to redundant efforts and misconceptions about clinical evidence,” said Dr. Joseph Ross, first author of the study and a Yale assistant professor of medicine. “Such inaction undermines both the trial in question and the evidence available in peer-reviewed medical literature. This has far-reaching implications for policy decisions, and even institutional review board assessments of risks and benefits associated with future research studies.”…

Ross said that there may be many reasons for lack of publication, such as not getting accepted by a journal or not prioritizing the dissemination of research findings. Still, he said, there are alternative methods for providing timely public access to study results, including the results database at ClinicalTrials.gov** that was created in response to Federal law.

[From the About Page at Clinical Trials.gov
US Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a “responsible party” (i.e., the study sponsor or designated principal investigator) register and report results of certain “applicable clinical trials” that were initiated or ongoing as of September 27, 2007…]

Related Resource

ClinicalTrials.gov

ClinicalTrials.gov  offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions.

ClinicalTrials.gov currently contains 118,682 trials sponsored by the National Institutes of Health, other federal agencies, and private industry.

**Here is how one can check for study results
(remember, researchers are not mandated to submit study results to ClinicalTrials.gov, they are voluntary)

    • Go to ClinicalTrials.gov
    • Click on Search (upper right corner)
    • Click on Advanced Search
    • Go to Study Results, use drop down menu to select Studies with results
    • Fill out rest of form with as much specific information as you can
      especially search terms, conditions, and/or interventions

ClinicalTrials.gov records with published results listed via the PubMed medical literature search service.  

  •         Use the Advanced Search with the search phrase clinicaltrials.gov[si]

Use the Builder  limit results by topics (as a disease, medical device), year(s), name of researcher/invesitator)

  •         Need help searching? PubMed has tutorials , including a YouTube at the Advanced Search Page

        Ask for assistance from a reference librarian at your local public, academic, hospital, or medical library.
Many academic, hospital, and medical libraries offer at least basic search help to all. Call ahead and ask
about their services. You may be pleasantly surprised.

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January 4, 2012 - Posted by | Biomedical Research Resources, Finding Aids/Directories, Tutorials/Finding aids | , , , , , ,

5 Comments »

  1. Howdy just wanted to give you a quick heads up.
    The text in your post seem to be running off the screen in
    Opera. I’m not sure if this is a format issue or something to do with browser compatibility but I figured I’d post to let you know.

    The layout look great though! Hope you get the issue fixed soon.

    Thanks

    Comment by bulk storage containers | June 22, 2013 | Reply

    • Thank you.
      Will remember to preview before posting!

      Comment by Janice Flahiff | July 14, 2013 | Reply

    • It seems to depend which browser one is using. Chrome seems to work the best. I checked this morning. Thank you!

      Comment by Janice Flahiff | June 23, 2016 | Reply

  2. ikntravel.com

    Many NIH-funded clinical trials go unpublished over two years after completion (with ClinicalTrials.gov link for many trial study results) « Health and Medical News and Resources

    Trackback by ikntravel.com | May 3, 2016 | Reply

    • It is hard to believe, but at least some NIH-funded clinical trials are not required to report to ClinicalTrials.gov
      See details at https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered
      For example
      *Phase 1 drug trials, including studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes (see note)
      *Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices, where the primary outcome measure relates to feasibility and not to health outcomes (see note)
      *Trials that do not include drugs, biologics, or devices (such as behavioral interventions)
      *Noninterventional (observational) clinical research (such as cohort or case-control studies)

      For complete statutory definitions and more information on the meaning of Applicable Clinical Trial, see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF).
      https://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf

      Yet, in my opinion, at least some NIHG-funded clinical trials may not be reported as required by FDA regulation.

      At the above pages I did not see how to report a researcher who did not submit as required. I would be happy to locate contact information for reporting those who are required to publish, but do not.
      Please email me directly at janice.flahiff@utoledo.edu

      Comment by Janice Flahiff | June 23, 2016 | Reply


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