Many NIH-funded clinical trials go unpublished over two years after completion (with ClinicalTrials.gov link for many trial study results)
[Flahiff’s note: It is possible that many of these unpublished clinical trial results would have made a positive difference in many people’s lives. These unpublished results have the potential of aiding many researchers.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.]
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These findings appear in the January issue of the British Medical Journal, which focuses on the topic of unpublished evidence.
“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…]
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)
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.
- Many NIH-funded clinical trials go unpublished over 2 years after completion (eurekalert.org)
- The White House Calls for Information on Public Access to Publications and Data (The Scholarly Kitchen)
- How to obtain free/low cost medical and scientific articles(jflahiff.wordpress.com)
- Patients want to understand the medical literature (with links to resources for patients) (jflahiff.wordpress.com)
- Missing trial data threatens the integrity of medicine (eurekalert.org)
- Poor patient recruitment cited in call for trial disclosures (fiercebiotechit.com)
- A Present for NIH: President Signs Law Creating New Translational Center (news.sciencemag.org)
- NIH and Non-profits Sign Research and Development Agreement (kauffman.org)
- NIH establishes National Center for Advancing Translational Sciences (jflahiff.wordpress.com)