It’s Not too Early to Consider Your Publication Strategy
-
Upload
fletcher-hampton -
Category
Documents
-
view
20 -
download
0
description
Transcript of It’s Not too Early to Consider Your Publication Strategy
Nutter McClennen & Fish LLPWorld Trade Center West155 Seaport BoulevardBoston, Massachusetts 02210Telephone 617.439.2000
www.nutter.com
It’s Not too Early to Consider Your Publication Strategy
Some things a company can do to mitigate surprises
MBC March 14, 2008
Nutter McClennen & Fish LLP • www.nutter.com
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
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
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
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
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
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
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
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
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
Regulator Communication
Who controls – sponsor, investigator, CRO?
Whose obligation?
Identify regulatory communication coordination issues in advance
Nutter McClennen & Fish LLP • www.nutter.com
Questions
Maria D. Buckley
Nutter, McClennen & Fish, [email protected]