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I'm Rob Logan, Ph.D., senior staff, U.S. National Library of Medicine (NLM).
Here is what's new this week in To Your Health - a consumer health oriented podcast from NLM - that helps you use MedlinePlus to follow up on weekly topics.
The head of the Food and Drug Administration (FDA) and other speakers at a recent conference suggested the reproducibility of biomedical research might improve if scientists could agree on a definition of 'reproducibility' and if more information about pre-clinical trial research findings was available and widely shared.
Robert Califf M.D., the commissioner of the FDA, suggested there may be a need for a new, clearinghouse database that could keep track of the basic science research that occurs prior to the initiation of clinical trials.
Califf told 75 attendees at a Friends of the National Library of Medicine reproducibility conference he was interested in the feasibility of (and we quote): 'something like a Clinicaltrials.gov for preclinical work' (end of quote). Clinicaltrials.gov provides standardized information about in-progress clinical trials as well as a database of findings about an FDA-approved drug's efficacy and side effects.
Hypothetically, Califf said the proposed project could provide access to data from the extensive preclinical research that involves lab animals or cells growing in laboratory dishes.
Califf explained a database of preclinical information also might improve research transparency as well as address occasional inabilities to reproduce some clinical research findings. Califf added currently there is no organized clearinghouse of preclinical information that is accessible to physicians, scientists, researchers and others around the world.
In another session during the two day conference (which featured national experts on research reproducibility and transparency), some expert panelists noted there is disagreement among scientists about how to define the term 'reproducibility.'
While the term 'reproducible' sometimes describes when consistent results occur in repeated scientific studies (despite small variations within an experimental set-up), a microbiologist from the University of Washington noted some scientists believe reproducibility only refers to the ability to achieve the same results within the same lab.
Ferric Fang M.D. explained these and other, current disagreements about what 'reproducibility' means make it difficult for scientists to know how to respond when peers allege irreproducible research methods and findings.
In addition, Fang explained if scientists cannot agree on what reproducibility means, their disagreements make it difficult for experts to find a common ground where honest differences and possible solutions about research inconsistencies can be considered.
Fang clarified he and the other panelists were discussing research discrepancies when there are no allegations of fraud or deceit by the original investigators. Fang noted the current debate about reproducibility is ethically principled and should not be confused with concerns about occasional scientific fraud and dishonesty.
Several conference attendees and speakers acknowledged it is rare for scientists and physicians to openly discuss research reproducibility issues in public. Several conference speakers also praised PubMed Commons, which is PubMed's effort to create a dialogue among scientists about the veracity, generalizability, and inferences drawn from research results.
PubMed Commons, which is published by NLM, now has its own website where you watch as scientists occasionally discuss the merits of each others' research findings. PubMed Commons, which was designed to boost reproducibility by fostering expert criticism of peer research, recently was promoted from a trial run to a permanent part of PubMed. PubMed is a gateway to refereed medical research published in major journals around the world.
You can find PubMed Commons by typing 'PubMed Commons' in the search box in any Internet search engine. The individual research abstracts within PubMed also indicate if there is a discussion about the article within PubMed Commons — and a link is provided. You can find PubMed by typing 'P...U...B...M...E...D' in the search box of any Internet search engine.
The Friends of the National Library of Medicine is a private foundation that supports NLM's activities. Towards the end of the reproducibility conference, several attendees urged the Friends to continue the topic of research reproducibility in the future and focus on access to (and criticism of) the clinical research that occurs after a drug or medical product is approved and marketed. We already look forward to writing a podcast about the latter topic if or when a future conference addresses this similarly overlooked issue.
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