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It’s Not too Early to Consider Your Publication Strategy

It’s Not too Early to Consider Your Publication Strategy. Some things a company can do to mitigate surprises MBC March 14, 2008. Overview of Some Key Issues . Publications committee Journal rules Scientific meetings Clinical trial registration/results disclosure Institutional publications

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It’s Not too Early to Consider Your Publication Strategy

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  1. It’s Not too Early to Consider Your Publication Strategy Some things a company can do to mitigate surprises MBC March 14, 2008

  2. Overview of Some Key Issues • Publications committee • Journal rules • Scientific meetings • Clinical trial registration/results disclosure • Institutional publications • SEC/Investigator Issues • Regulator communication Nutter McClennen & Fish LLP • www.nutter.com

  3. Publications Committee • Is this a multi-site trial? • Is the Sponsor going to form a Publications committee? • If so, which individuals are going to accept direct responsibility for the manuscript? Nutter McClennen & Fish LLP • www.nutter.com

  4. Research Agreements • Can address some of these issues • Cannot “gag” researchers, but can define how long Sponsor has to review site’s proposed publication, typically 30 – 60 days • Can define how long will Sponsor will have for first publication before site can publish its results, typically 12 – 18 months • Can clarify that site/investigator is in possession of Sponsor’s material non-public information Nutter McClennen & Fish LLP • www.nutter.com

  5. Clinical Trial Disclosures • International Committee of Medical Journal Editors (ICMJE) publication requirements - to publish study results in a top tier journal it must be registered before first patient in for trials beginning on or after July 1, 2005, for ongoing trials, must be registered by September 13, 2005 • www.icmje.org Nutter McClennen & Fish LLP • www.nutter.com

  6. Clinical Trial Disclosures • State laws • Maine http://www.maine.gov/dhhs/boh/clinical_trials.htm/index.htm • Virginia http://www.hhr.virginia.gov/FAQs/trials.cfm Nutter McClennen & Fish LLP • www.nutter.com

  7. Clinical Trial Disclosures • Federal laws • www.clinicaltrials.gov established for NIH-funded clinical research. FDAMA then required the Clinical Trials Data Bank for serious and life-threatening diseases. • FDA Amendment Act of 2007 section 801 requires registration of all clinical trials other than Phase One and disclosure of results. This provision pre-empts state law. Regulations expected to be effective 2010. Nutter McClennen & Fish LLP • www.nutter.com

  8. Journal Rules • Top Tier journals will follow ICMJE rules • Embargo rules • Author/Contributor/Guarantor criteria • Each member of a group publication must meet the criteria as applicable • Peer Review – confidential, anonymous • Other disclosures, e.g., Conflicts of Interest Nutter McClennen & Fish LLP • www.nutter.com

  9. Scientific Meeting Presentation • Which Organization? • Which Meeting? • Follow Abstract submission rules • How does presenting at a scientific meeting affect journal publication? Nutter McClennen & Fish LLP • www.nutter.com

  10. Institutional Publications • What will the institution publish about the trial, e.g., funding sources, protocol name? • Where will be it published, e.g., alumni news? • Do you need proprietary information protections if research is at a state institution? • “Use of Name” provisions Nutter McClennen & Fish LLP • www.nutter.com

  11. Regulator Communication • Who controls – sponsor, investigator, CRO? • Whose obligation? • Identify regulatory communication coordination issues in advance Nutter McClennen & Fish LLP • www.nutter.com

  12. Questions • Maria D. Buckley • Nutter, McClennen & Fish, LLP617-439-2709mbuckley@nutter.com Nutter McClennen & Fish LLP • www.nutter.com

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