It’s Not too Early to Consider Your Publication Strategy

Nutter McClennen & Fish LLPWorld Trade Center West155 Seaport BoulevardBoston, Massachusetts 02210Telephone 617.439.2000

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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


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?


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


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

http://www.icmje.org/



State laws

Maine http://www.maine.gov/dhhs/boh/clinical_trials.htm/index.htm

Virginia http://www.hhr.virginia.gov/FAQs/trials.cfm

http://www.maine.gov/dhhs/boh/clinical_trials.htm/index.htm

http://www.maine.gov/dhhs/boh/clinical_trials.htm/index.htm

http://www.hhr.virginia.gov/FAQs/trials.cfm



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.

http://www.clinicaltrials.gov/


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


Scientific Meeting Presentation

Which Organization?

Which Meeting?

Follow Abstract submission rules

How does presenting at a scientific meeting affect journal publication?


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


Regulator Communication

Who controls – sponsor, investigator, CRO?

Whose obligation?

Identify regulatory communication coordination issues in advance


Questions

Maria D. Buckley

Nutter, McClennen & Fish, [email protected]

mailto:[email protected]

It’s Not too Early to Consider Your Publication Strategy

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