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NLM Director’s Comments Transcript
Drug Approval Process Insights from
Greetings from the National Library of Medicine and MedlinePlus.gov
Regards to all our listeners!
I'm Rob Logan, Ph.D. senior staff National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.
Two research letters, both recently published in the Journal of the American Medical Association, suggest the potential to use clinicaltrials.gov as a resource to glean insights about the process to approve drugs and medical devices in the U.S.
For example, the first research letter suggests there are comparative discrepancies between the results published in major medical journals and a data set of the overall results about the same trial published in clinicaltrials.gov.
To backup momentarily, a standardized format that reports the primary results of clinical trials for medications and some medical devices (approved by the U.S Food and Drug Administration) has been required to be available on clinicaltrials.gov since 2009. Articles in medical journals are derived routinely from a more comprehensive data set of clinical trial findings.
The fact there may be differences between the focus of subsequent journal articles and the data set from which they are derived is less an issue in medical research and practice than more specific, comparative discrepancies such as differences in: the description of the study population (or cohorts), details about the intervention, or reports about some findings.
Yet, the first research letter notes consistent discrepancies in at least one of the latter categories in a comparison of 96 clinical trials in major medical journals with the clinicaltrials.gov data set. The authors, from Yale University School of Medicine, assessed articles from the most cited medical journals with clinicaltrials.gov’s primary results from July 1, 2010 to June 30, 2011.
The Yale authors write (and we quote): ‘because articles published in high-impact journals are generally the highest-quality research studies and undergo more rigorous peer review, the trials in our sample likely represent best-case scenarios with respect to the quality of results reporting’ (end of quote).
The authors of the first research letter continue (and we quote): ‘Our findings raise questions about the accuracy of both clinicaltrials.gov and publications, as each source’s reported results at times disagreed with the other. Further efforts are needed to ensure accuracy of public clinical trial result reporting efforts’ (end of quote).
Incidentally, clinicaltrials.gov’s findings are supplied by the enterprise that generated the trial. While the staff at clinicaltrials.gov (which is an NLM website) check for face validity upon submission to ensure the overall results make common sense, the overall responsibility for reporting specific findings rests with the research’s originator.
The second research letter, partly co-authored by members of clinicaltrials.gov’s staff, suggests there may be gaps in the laws that provide federal human subject protections for some of the clinical trials conducted in the U.S. The research suggests of 23,963 sampled trials from clinicaltrials.gov’s records, federal human subject protections may not have covered some of the clinical trials within the data set. This latter finding does not mean human subject protections did not occur. Instead, the findings suggest many clinical trials may not fall under existing federal human subject regulations.
The authors acknowledge the findings are based on a sample, rather than a universe of trials in clinicaltrials.gov’s data set, and the authors note the estimates provided within the current findings might vary with different methodological approaches. However, the authors write (and we quote): ‘Our analysis provides the first quantitative estimate of the size of (a) gap in regulatory coverage…’ (end of quote).
The authors add (and we quote): ‘…this analysis is intended to inform ongoing discussions about potential regulatory reforms’ (end of quote).
Although the two sets of findings cover very different topics, taken together they illustrate the potential of clinicaltrials.gov’s records as a data set to assess different aspects of the drug and medical device approval system. Apparently, clinicaltrials.gov can be used successfully to assess the quality of clinical findings over time as well as the coverage of some regulatory policies intended to oversee medical research ethics and safety.
Clinicaltrials.gov is accessible by typing ‘clinicaltrials.gov’ in any web browser. User instructions for patients and families are provided in the upper left corner of the website’s home page.
MedlinePlus.gov also has a health topic page devoted to clinical trials, which provides broad information about this essential part of the medical research process. For example, a guide to help you understand clinical trials (provided by the National Institutes of Health) is available in the ‘start here’ section of MedlinePlus.gov’s clinical trials health topic page.
MedlinePlus.gov’s clinical trials health topic page also provides links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. You can sign up to receive updates about clinical trials as they become available on MedlinePlus.gov.
To find MedlinePlus.gov’s clinical trials health topic page type ‘clinical trials’ in the search box on MedlinePlus.gov’s home page, then, click on ‘clinical trials (National Library of Medicine).’ MedlinePlus.gov also has a health topic page devoted to understanding medical research.
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It was nice to be with you. I look forward to meeting you here next week.