It

1
Its 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

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?

4
Research Agreements

• Can address some of these issues
• Cannot gag researchers, but can define how long
  Sponsor has to review sites 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 Sponsors material non-public
  information

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

6
Clinical Trial Disclosures

• State laws
• Maine http//www.maine.gov/dhhs/boh/clinical_trial
  s.htm/index.htm
• Virginia http//www.hhr.virginia.gov/FAQs/trials.c
  fm

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.

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

9
Scientific Meeting Presentation

• Which Organization?
• Which Meeting?
• Follow Abstract submission rules
• How does presenting at a scientific meeting
  affect journal publication?

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

11
Regulator Communication

• Who controls sponsor, investigator, CRO?
• Whose obligation?
• Identify regulatory communication coordination
  issues in advance

12
Questions

• Maria D. Buckley
• Nutter, McClennen Fish, LLP617-439-2709mbuckle
  y_at_nutter.com