Impact of Clinical Trial Data Disclosure on Publication Disposition

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1 DISCLAIMER: The content of this presentation may not accurately reflect current legal or regulatory requirements, industry standards, or professional best practices. ISMPP is providing access to this presentation as a member service only, and does not recommend or condone the use of this presentation in whole or in part to support legal or professional decisions or practices. Impact of Clinical Trial Data Disclosure on Publication Disposition Carl Clay, PhD Robert Norris, MBA Edward Paluch, MBA, PhD Complete Healthcare Communications, Inc. Chadds Ford, PA

2 Clinical Trial Registration ICMJE Established manuscript submission guidelines Revised several times, most recently February 2006 III.D.2. Redundant Publication Redundant (or duplicate) publication overlaps substantially with one already published in print or electronic media. III.J. Obligation to Register Clinical Trials The ICMJE member journals will require, as a condition of consideration for publication in their journals, registration in a public trials registry. Accessed April 2,

3 Clinical Trial Results Posting European Federation of Pharmaceutical Industries and Associations (EFPIA) International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Japanese Pharmaceutical Manufacturers Association (JPMA) Pharmaceutical Research and Manufacturers of America (PhRMA) Express member companies commitment to post data derived from completed clinical trials on all marketed products in an accessible clinical trial results database Accessed April 2,

4 Potential Impact of Results Disclosure some editors consider merely the posting of clinical trial data to an online repository as an action on our part that may jeopardise the opportunity to have the trial subsequently reported in their journals. III.D.2. Redundant Publication Preliminary reporting to public media, governmental agencies, or manufacturers, of scientific information described in a paper or a letter to the editor violates the policies of many journals. Rockhold FW, Krall RL. Lancet 2006;367: Accessed April 2,

5 Case Study Categories Submitted Manuscript Manuscript Under Review Accepted Manuscript 5

6 Case Study 1 Submitted Manuscript Manuscript submitted for publication Pharmaceutical company wanted to post trial data Author query: confirm that this action will not jeopardize publication of our manuscript in your journal. Journal response: If the main bulk of the results are posted in the way you suggest, then we may feel that publication in our journal will duplicate this unnecessarily. 6

7 Case Study 2 Manuscript Under Review Manuscript under review Pharmaceutical company wanted to post trial data Author query: would such a posting represent prior publication in the eyes of the Journal? Journal response: online posting of the synopsis before publication of your full paper would result in withdrawal of the paper from further consideration proceeding with publication of the full paper could be viewed as duplicate publication. 7

8 Case Study 3 Accepted Manuscript Manuscript accepted for publication Pharmaceutical company wanted to post trial data Author query: if posting the clinical trial data would place publication of the full manuscript at risk. Journal response: The embargo date for your article which is being published in the Journal [name withheld] is [date withheld]. Therefore, no information regarding this study should be disclosed prior to this date. 8

9 Dear [Editor], Complete Healthcare Communications, Inc is a strategic medical communications company. We would like to know if your journal [Journal] has a policy regarding the posting of clinical trial data on a publicly accessible website and its potential impact on future manuscript publication. Can you please outline your policy? We greatly appreciate your time with this request. Sincerely, Carl Clay, PhD Medical Director Complete Healthcare Communications, Inc 1 Dickinson Drive Chadds Ford, PA Tel: Fax: Carl.Clay@CHCinc.com 9

10 Journal Survey 31 Unusable 200 Journals 89 Responses 58 Useable Top 100 Journals Lower 100 Journals Does journal have publication policy? No 20% Yes 60% N/A 20% No 29% Yes 43% N/A 19% Would the journal publish if data were posted? No 22% Yes 72% Case-by-case 6% No 8% Yes 75% Case-by-case 17% 10

11 Conclusions Journal policies are evolving Current journal policies regarding redundant publication may be in conflict with the policies of pharmaceutical organizations regarding posting of clinical trial data Differential responses from the journal survey reveal that there is no one clear policy 11

12 Recommendations Medical Communication Agencies Pharmaceutical Companies Journal Editors 12

13 Medical Communication Agencies Inform pharmaceutical clients and authors that: Different journals may have different policies regarding publication of posted clinical trial data These policies are evolving Query individual journal editors regarding their publication policies prior to manuscript development Understand client timelines regarding posting of clinical data: Establish / maintain relationships with pharmaceutical clients for ongoing communication for publication planning 13

14 Pharmaceutical Companies Maintain ongoing awareness of: Clinical trial timelines Dates for posting clinical trial data Develop relationship with publication agency for didactic exchange of information 14

15 Journal Editors Develop and share your publication policy with: Authors Pharmaceutical companies Medical communication agencies Post policy on website for manuscript submission guidelines and instruction to authors 15

16 Thank you!