the 9th annual meeting of ismpp

The 9th Annual Meeting of ISMPP

Empowering the Medical

Publication Community to

Advance the Profession

New Players: An External

Perspective

Tom Drake

Vice President, Business Development

The JB Ashtin Group

The Evolving Forces in Publication

Planning

Today’s Panel

• Bill Silberg Director of Communications, Patient-Centered Outcomes Research Institute (PCORI)

• Sarah Feeny, BSc, CMPP Head of Scientific Direction, Complete Medical Communications

• David Queen Attorney at Law, Queen Law

• Fiona Godlee, MD Editor-in-Chief, BMJ

• Moderator: Kim Pepitone, CMPP Scientific Director, Cactus Communications

All views expressed are the panelist‘s and do not necessarily reflect the views or policies of their employer or ISMPP

Examples in History: External Forces in Science and Medicine

• External forces have been and will continue to impact scientific and medical publishing

• Maimonides (Physician/Lecturer/Philosopher/Rabbi) & Saladin

Published 10 Medical Treatises under the direction of Saladin’s Court

• Galileo & Pope Urban VIII – Published & Punished

“Dialogue Concerning the Two Chief World Systems” and subsequent trial in 1633

New Players:

An External Perspective


Planning

Kim Pepitone, CMPP

Scientific Director, Cactus Communications

Moderator

External Factors

Transparency Data

Publications Financial relationships

World Wide Web

Clinical Efficacy& safety

HEOR/CER

Government Rules & regulations

False claims CIAs

Litigation

Conflict of interest Financial Academic

Patient

A Changing Scholarly Communications

Landscape: PCORI’s Perspective

Bill Silberg, Director of Communications, PCORI

Washington, DC`

[email protected]

www.pcori.org

Disclaimer

• The views and opinions expressed in this presentation are my own and, unless otherwise indicated, not those of the Patient-Centered Outcomes Research Institute

• I have no conflicts of interest to disclose

• I have received no compensation for my talk today, including travel support

Our Communications and Publishing Challenges

• We serve multiple audiences (per the PPACA) – including patients, caregivers, researchers, clinicians, policymakers, payers, employers

• We must explain what we do, why and what it means, in a field that is still evolving and can be highly technical (CER/Patient-Centered Outcomes Research)

• We don’t yet have study results to talk about – good research takes time, and our first primary studies were only approved in December 2012


What the law requires of us

• We must meet these tests without jeopardizing our supported researchers’ ability to publish in the peer-reviewed literature

– Peer review: We must provide for a peer review process for our primary research

– Timeline: We must make information available within 90 days “after conduct or receipt of research findings”

– Audiences: Our information must be “comprehensible and useful to patients and providers in making health care decisions”


• What we require of applicants

– Replication and Reproducibility of Research and Data Sharing Plan: Study protocol, registration, description of datasets, full de-identified datasets for larger studies

– Dissemination and Implementation Assessment: How will facilitators of dissemination/implementation be engaged throughout the research process?

– Public Abstract of Research Plan: In addition to technical abstract

• We also seek to promote open access in real time

So What’s a Research Institute To Do?

• Build visibility and “brand”

• Focus on “results” we have (methods standards)

• Focus on what we’re learning

• Find good “stories” about everything else

• Set the stage for the work to come

• Start planning for the dissemination of our research results by building a “communications community”

12

EMA Perspective

Sarah L. Feeny, CMPP

Head of Scientific Direction at Complete Medical

Communications

Then Then Then and now

Publishers

Sponsors

Journals

Writing Agency

Authors

Institutes

Editor groups

ISMPP / GPP

Governments & reg. bodies

Presented by Sarah Feeny at ISMPP Annual Meeting 2013

Patient & public interest groups

Sponsor bodies

European Commission: Regulations and directives on trial data disclosure

Apr 2001 EC Directive 2001/20/EC

Provision for protocol registration on EudraCT

May 2004 Studies to be entered onto

EudraCT

May 2004 EC Regulation 726/2004

Provision for public access to EudraCT

Mar 2011 EudraCT v.8

Public access to protocols

2001 2002 2003 2004 2006 2007 2008 2009 2010 2011 2012 2013 2014


End 2013 First production release

of results database

Entry of results onto results database

for all studies started since May 2004

EMA Workshop on clinical trial data and transparency: 22 Nov 2012

EMA executive Director said “We are not here to decide if we publish clinical trial data,

but how”

How? What data?

What format? To whom?

“EMA are not here to decide if we make public

anonymised patient-level data, but how”


EMA Workshop on clinical trial data and transparency: 2013 activities

• Q1 2013: Advisory committees to convene

– protecting patient confidentiality

– clinical-trial-data formats

– rules of engagement

– good analysis practice

– legal aspects

• 30 Jun 2013: draft policy for public consultation

• 30 Sep 2013: public consultation to conclude

• Nov 2013: final policy

• 1 Jan 2014: Policy to come into force


Implications

? Could this lead to even worse publication-bias

? Will sponsors need to work more quickly with Author Steering Committees to determine which (and publish) post-hoc- & sub-analyses will benefit the medical community (or risk such analyses being conducted by other researchers)

? Will new divisions be created within sponsor companies to analyse competitor data


Editor's Perspective

Fiona Godlee, MD

Editor –in-Chief, BMJ

19

Doshi P, BMJ 2009

Trials of Reboxetine Eyding D et al. BMJ 2010;341:bmj.c4737

Forest plot showing meta-analysis of published, unpublished, and all trials

BMJ 2010;341:c4942

There is an “Alice in

Wonderland” feel to these

investigators’ efforts—acting on

the public’s behalf, searching

over hill and dale and among

the paperwork of regulatory

bodies and drug companies to

put together pieces of data that

should have been freely

available in the first place.

BMJ Editorial by Loder and Lehman R. BMJ 2012

Concealment of data should be

regarded as the serious ethical

breach that it is, and clinical

researchers who fail to disclose

data should be subject to

disciplinary action by

professional organisations. This

may achieve quicker results

than legislation in individual

countries, although this is also

desirable.

alltrials.net

Corporate Integrity Agreements, Litigation, and

Penalties: Do These Affect Publication

Planning?

David Queen,

Attorney at Law, Queen Law

What Should Medical Publication Professionals Do?

Before starting with or for a health care provider or pharma/biotech/device company

• Ask if they are or have been excluded from Medicare or Medicaid then check the OIG provider exclusion list

• Ask if they are currently operating under a CIA, then check the DOJ and HHS CIA lists

• Get a copy of the parts of the CIA that may affect your work

• Determine if the provider has a compliance program with policies relevant to your work – if so, get them

• Know who to ask for advice and answers (eg, compliance officer, in-house counsel)

Publication Plans and CIAs: What Are the Musts?

• Within ~120 days from being put under a CIA, company must establish documented planning process

• Business needs for publication must be identified

• Needs assessments must be performed prior to author engagement

• Budget must be established

• Written author agreements must be executed

• Compliance personnel must be included

• Any deviations from the plan must be documented

So How Does This Affect What We Do?

US Federal Gov’t Litigation & Penalties

• Over $16 billion USD in penalties from 1991-2012

• Nearly $8 billion between 2010-2012

• Categories for violations

– Financial violations

– Illegal distribution

– Environmental violations

– Unlawful promotion

– Concealment of study findings

– Monopoly actions

– Poor drug manufacturing

Could relate to publications

At the State Level

J&J Janssen Settlement (2012)

• Settled with 37 states’ attorneys general for $181 million for promoting off-label uses for two antipsychotic drugs.

• The settlement also included changes to J&J’s promotional activities

– No peer-reviewed articles disseminated by sales or marketing personnel unless an off-label use supplemental application has been submitted to the FDA for approval

– Peer-reviewed articles may be submitted by scientists to other scientists even without pending application

Wall Street Journal (4.23.2013)

What Should Medical Publication Professionals Do?

• An ounce of prevention is worth a pound of cure1

• Take steps to know what you need to do and not do, and follow it

– Have a compliance program in place

– Written policies and procedures

– Document your adherence

1Benjamin Franklin

If it isn’t documented, it didn’t happen!

New Players: An External

Perspective


Planning

Panel Discussion

Audience Q&A

The 9th Annual Meeting of ISMPP

Empowering the Medical

Publication Community to

Advance the Profession

the 9th annual meeting of ismpp

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