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Preprints: What, Why and How
Harlan M. Krumholz, MD Yale School of Medicine @hmkyale
Preprints: What, Why and How Harlan M. Krumholz, MD Yale School of - - PowerPoint PPT Presentation
Preprints: What, Why and How Harlan M. Krumholz, MD Yale School of - - PowerPoint PPT Presentation
Preprints: What, Why and How Harlan M. Krumholz, MD Yale School of Medicine @hmkyale Disclosure PCORI Board; United HealthCare and Aetna Advisory Committees; Grant from JNJ to distribute clinical trial data; grant from Medtronic, in
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https://www.youtube.com/watch?v=2zMgY8Dx9co
Preprints
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Preprints
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Not everyone is a fan…
JAMA September 26, 2017 Volume 318, 1109-10
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JAMA Vol 318, 1109-10
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JAMA September 26, 2017 Volume 318, 1109-10
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JAMA September 26, 2017 Volume 318, 1109-10
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Dual Nature of Medical Journals
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Please try to keep an open mind
@emmyzen
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What problem are we trying to solve? How do we easily and rapidly archive and share information with other scientists to accelerate research, enhance collaboration, reduce waste, increase transparency?
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https://www.youtube.com/watch?v=2zMgY8Dx9co
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Preprint Servers Complementary to, and not a replacement for, peer review journals.
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Science for Scientists
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DOI (Digital Object Identifier)
DOI is unique alphanumeric string assigned by registration agency (International DOI Foundation) to identify content and provide a persistent link to its location on the Internet.
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Pre-peer review results already released…
Major journals already allow pre-peer review release of information.
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For example…
Medical meetings Clinicaltrials.gov Press releases
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But…
Information often incomplete May not be citable May not be searchable
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And…
No opportunity for community comments/dialogue
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IMPROVE-IT Trial
Study Results Reported Results First Announced: August 28, 2014 Trial First Presented: November 17, 2014 Paper published: June 3, 2015
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Lack options for less publishable products…
Protocols/Technical reports Quality innovations White papers
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Unpublished Trial Data
Many trials are never reported –
- r are delayed by years.
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http://www.who.int/ ictrp/results/jointstat ement/en/
We will work towards a timeframe of 12 months from primary study completion (the last visit of the last subject for collection of data on the primary outcome) as the global norm for summary results disclosure.
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Jeremy Farrar, Director Wellcome Trust
“Not only will this help ensure that these research findings are more discoverable, but it will also reduce reporting biases, which currently favor publication of trials which have a positive outcome.”
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Trevor Mundel, Pres GH Gates Foundation
"It's a 21st-century best practice – and an essential part of the social contract that underlies medical research – that clinical trial data should be made publicly available less than one year after a clinical trial's completion."
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https://s3.amazona ws.com/public- inspection.federalre gister.gov/2016- 22129.pdf
In general, results information must be submitted no later than one year after the completion date
- f the applicable
drug clinical trial.
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BMJ (@bmj_latest)
http://www.bmj.com /content/bmj/352/b mj.i637.full.pdf
Only 29% of completed clinical trials conducted by the faculty at major academic centers were published within two years
- f completion and only
13% reported results on ClinicalTrials.gov
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And then there is speed…
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Protocol Papers
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Concern: Fake News
There is already too much fake information
- ut there.
http://www.intellectualtakeout.org/blog/5-reasons-why-fake-news-here-stay
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Concern: There is already too much information.
https://www.flickr.com/photos/intersectionconsulting/7537238368
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About volume…
https://hcsmmonitor.com/2015/10/29/information-overload/
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Concern: Public may act prematurely. Harm may accrue.
https://commons.wikimedia.org/wiki/File:Singapore_Road_Signs_-_Warning_Sign_-_Danger.svg
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Concern: May undermine Clinicaltrials.gov
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Risk Mitigation High-level screen IRB-approved or exempted Require posting on clinicaltrials.gov Corresponding author: ORCHID Labeling and watermarks
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Concern: Publication
Will this jeopardize peer-review publication?
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Journal Policies
Many journals allow preprints, including BMJ, Science, Nature and others.
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Journal Policies
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Journal Policies
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https://www.youtube.com/watch?v=2zMgY8Dx9co
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Growing use in biology: bioRxiv
http://asapbio.org/preprint-info/biology-preprints-over-time
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Yale Data Open Access (YODA) Project
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When is the right time?
Yoda.yale.edu
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When is the right time?
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Medical Preprint Server
Community resource Stewards not owners Iterative learning
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Goal Not to establish a server But to improve and accelerate science, promote collaboration, enhance transparency, reduce waste Improve over time
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Ask… Journals should allow co-existence of pre-print servers and not penalize scientists who use them. Is there really a difference from presenting at a meeting?
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