spirit’s spotlight on ismpp! · “mega journals” such as plos one or bmj open offer broad...

GPP3 –

how is it

going?

Real World

Evidence

(RWE) and

publications

Patient lay

summaries

Data and

financial

transparency

reporting

ISMPP

update

Publishing

and

journals

Novel

research

Corporate

Integrity

Agreements

(CIA)Copyright

Where

do we go

from here?

Spirit’s Spotlight on ISMPP!

Publication planning in practice: Overcoming challenges in the age of transparency

2016 European Meeting of ISMPP

19–20 January 2016, London, UK.

INTRO

GPP3

http://annals.org/article.aspx?articleid=2424869

INTRO

1Highlights from 2016 European Meeting of ISMPP

Welcome to Spirit’s overview of the 2016 European Meeting of ISMPP!

Members of the Spirit team attended the recent ISMPP meeting and have summarised their key learnings in this newsletter, which

we hope you find useful. With over 200 registered attendees, every session was packed. While most attendees were from medical

communications agencies, pharma and publishers were also well represented.

2015 was a busy year in the world of medical publications – Iain Hrynaszkiewicz, PhD, Head of Data and Health & Social Sciences

Publishing, Nature Publishing Group/Palgrave Macmillan (UK), kicked the meeting off with an excellent overview of the key events:

seems we have come along way since the first scientific journal was published 350 years ago!

JAN FEB MAR APR MAY JUN JUL AUG SEPT OCT DECNOV

International open-access week.

Rise of predatory journals – check Beall’s

list (scholarlyoa.com/publishers/).

www.thinkchecksubmit.org launched to

help identify more reputable journals.

Need to make sure reputation of open

access journals is not damaged by

predatory journals.

Directive issued by

Chinese government

forbidding use of third-

party agencies to help

with writing/editing

research reports –

focus is on training

Chinese medics to be

better writers.

Potential impact on

med comms in Asia?

ICMJE updated to

include warning about

predatory journals,

encourage ORCID

and relax rules on

prior publication

in cases of public

health emergencies.

Altmetric data

used to indicate

use of data saved

on

clinicaltrials.gov.

“Restoring

study 329…”

BMJ 2015:351 –

reassessing the

original data set

resulted in a

different

conclusion from

the original

publication

64 articles retracted

from 10 journals due

to fabricated reviewer

reports. “Peer-

Review

Fraud – Hacking

the Scientific

Publication Process”

N Engl J Med

2015;373:2393−5.

GPP3 released.

Have COI gone too far?

“The license to trample the

credibility of physicians

interactions with industry

has silenced debate"

NEJM 2015;372:2064-68.

Launch of 'Research

Involvement and

Engagement' journal with

patient advocate as editor.

Discrepancies between

research considered

important by patients and

studies actually performed.

BMJ announce

extension to policy

for sharing data from

all clinical trials.

Data sharing

statements are

now being included

in publications

(i.e. info on how the

original data can

be accessed).

More evidence of

publication bias

– people are

talking about

it more and

the topic

is hitting

mainstream

news channels.

Launch of

Opentrials.com

announced

(Ben Goldacre).

Reported

increase in

importance of

interdisciplinary

research (not just

medics, but

social scientists).

350th

anniversary

of world’s

first science

journal

(Philosophical

Transactions).

GPP3 –

how is it

going?

2

HOT TOPIC GPP3 – how is it going? Outstanding queries were addressed by a multidisciplinary faculty including an author, a med comms representative,

a pharma representative and a journal editor:

Dan Bridges, MS, PhD, ISMPP CMPPTM (Nucleus Global)

Ana Marušić, MD, PhD (University of Split/Journal of Global Health)

Elizabeth Wager, MA, PhD (Sideview)

Nicole Rapior, MS, PhD (Boehringer Ingelheim)

Moderator: Dawn Lobban, PhD, ISMPP CMPPTM (Spirit Medical Communications)

Published in August 2015.

Extensive presentation and endorsement around the globe in different languages.

But, the more practical the guidelines become, the more people look to them for exact scenarios –

discussion and interpretation will always be needed and this was demonstrated during this session.

GPP3 authors

10%

Use/regularly refer to

40%

Have read50%

100% awareness of GPP3 among attendees!

TAKE HOME MESSAGES Key GPP3 topics for further discussion/clarification as identified by ISMPP

attendees: authorship and author payments and data sharing.

ICMJE criteria apply to all authors, both internal and external: GPP3 provides

practical guidance on how to interpret ICMJE criteria.

While pharma are keen to maintain a clear distinction, there are situations

where medical writers may qualify as authors e.g. reviews – and they should

be paid for their services.

Kick-off calls are important! Arrange early to include all authors and/or

consider having more than one.

Negative data are important – choice of journal is key to ensure publication.

Clear need for increased awareness of GPP3, especially among academics:

GPP3 applies to all publications, not just commercially-sponsored research!

Highlights from 2016 European Meeting of ISMPP

Real World

Evidence

(RWE) and

publications

3

HOT TOPIC Real World Evidence (RWE) and publicationsRichard White, MA, PhD, Commercial Director, Oxford PharmaGenesis Ltd, gave an interesting presentation

on the risks and benefits of publishing RWE.

RWE is a relatively new discipline but has similarities to traditional randomised clinical trials (RCTs).

However, RCTs exclude patients who don’t meet strict criteria, whereas RWE includes observational data from a range of sources.

RWE assesses how medicines are used in everyday practice, outside the constraints of RCTs.

The increasing need to communicate RWE data has implications for planning and developing publications!

TAKE HOME MESSAGES RWE publication policies are needed and should be based on existing guidelines.

When identifying potential authors to review and publish data from

registries, follow the same approach as for RCTs.

Confounders and bias are important considerations that need

to be addressed in RWE studies – need for education!

When did you last read about a RWE study where the sponsoring company did not “win”? As for RCTS,

guidelines and publication policies are needed to ensure all studies are published irrespective of the outcome.?45% of the

audience didn’t

know if the

company they are

currently working

for has a

RWE publication

policy!


Patient lay

summaries

The era of the

lay summary is

upon us and

patients are not

going away!

4

HOT TOPIC Patient lay summariesRachel Jones, PharmD, of AstraZeneca and Richard Stephens, a patient advocate and blogger, led a roundtable

discussion about communicating directly to patients.

Informed patients experience better outcomes and provide an economic benefit across the healthcare system.

The needs of inquisitive, and in many cases desperate, patients has driven lay summary development.

TAKE HOME MESSAGES Lay summaries are needed to accurately explain data – patient-to-patient online

conversations can be very misleading!

Patients are a very heterogeneous group – it will never be possible to write

something that works for all.

Skilled writers are needed who understand the data and therefore know

what needs to be included.

Important to test patient summaries on real patients (i.e. not expert patients).

Public funding bodies are increasingly demanding publications that include

a lay summary of research.

Online lay summaries should be published alongside the research article but

most journals are not resourced to check the quality of lay summaries.

Manuscripts should be rejected if editors don’t understand the lay summary.

Don’t limit yourself to words – visuals can be really useful.

Pharma has concerns that lay summaries in industry-sponsored publications

could be perceived as a type of direct-to-patient promotion: when solicited by

the journal they are often outsourced to a third party.


Data and

financial

transparency

reporting

6

HOT TOPIC Data and financial transparency reportingA faculty of representatives from different backgrounds led an in-depth discussion on changes to rules

and directives on data transparency. The faculty included:

Slavka Baronikova, PharmD, PhD, ISMPP CMPPTM (Shire),

Ana Marušić, MD, PhD (University of Split/Journal of Global Health),

Andy Powrie-Smith (EFPIA),

Laurence Rouxhet, ISMPP CMPPTM (GSK),

Fergus Sweeney (European Medicines Agency),

Moderator: Thomas Wicks (TrialScope)

Requirements for transparency regarding data reporting

are becoming more widespread.

Since publication of the EFPIA/phRMA principles on

data sharing1, companies have made great progress in

developing processes for clinical trial data access schemes,

translating principles into practice.

Implications for publication planning!

Different approaches to data sharing: collaborative

(many companies/organisations together), partnership

(two companies/organisations together), standalone.

TAKE HOME MESSAGES By the time an article is published, much of the information regarding the

dataset is already in the public domain. Need for disclosure alignment to

ensure consistency!

The pharmaceutical industry is accepting more and more requests for data

access after a primary publication is released. Must be for a valid research

reason and be supported by a valid analysis plan.

Challenges arise when investigators want to only publish data of clinical interest,

but pharma are concerned about what is being left out vs. full disclosed data set.

Variation in how different pharmaceutical companies interpret EFPIA guidance

on data transparency and transfer of value (TOV): GSK consider publication

support as a TOV whereas Shire currently don’t.

The drive for

increased

transparency will

never reverse.

As medical

communicators,

we need to

lead this.

Highlights from 2016 European Meeting of ISMPP 1www.efpia.eu

1

Enhancing data

sharing with

researchers

2

Enhancing

public access to

clinical study

information

3

Certifying

procedures for

sharing clinical

trial information

4

Sharing results

with patients

who participate

in clinical trials

Reaffirming

commitments to

publish clinical

trial results

5

Principles for responsible clinical trial data sharing

ISMPP

update

7

HOT TOPIC ISMPP updateMembers of the ISMPP committee presented a comprehensive overview of ISMPP’s activities over the past year

and its aspirations for the future.

ISMPP’s profile has increased in recognition over the past year.

Requests for ISMPP presentations have come from various organisations.

ISMPP has also received GPP3 endorsements and requests for presentations on GPP3.

The reach is broadening: successful ISMPP conferences held in Beijing and Tokyo during 2015:

TAKE HOME MESSAGESISMPP Strategic Imperatives:

1. Evolve and visibly advocate best practices.

2. Broaden global presence and outreach.

3. Collaborate and build relationships with key external stakeholders.

4. Increase membership and sponsors, effectively supporting their

current and future needs.

5. Align internal infrastructure, resources and processes

with evolving requirements.

58%22%

9%

9%2%

>70 attendees at each of the Asia-Pacific meetings,

from a variety of backgrounds!

Industry

Med comms agency

Academia

Journals

Government


Most ISMPP CMPP™ certificate holders are from Europe and North America: this is seen as a recognition of quality

and should be a key consideration for publication managers when choosing an agency.

As ISMPP expands into new regions, the hope is that the society may “continue to convene and bring together

inspired publication professionals each year in forums like the 2016 European Meeting”.

All attendees said they would attend another

ISMPP meeting!

Publishing

and

journals

8

HOT TOPIC Publishing and journals: practical

considerations for medical publication professionals in 2016 A panel of representatives led the debate on publishing and journals in 2016:

Amy Bourke-Waite (Springer Nature), Maria Kowalczuk, PhD (BioMed Central), Tom Rees, MS, PhD, ISMPP CMPPTM (PARAEXEL),

Anna Sharman, PhD (Cofactor). Moderator: Elizabeth Wager, MA, PhD (Sideview).

Advancements in digital technology (social media, altmetrics, novel digital platforms, mega-journals, open access, and novel peer-

review models) have brought about new challenges for medical publication professionals.

These challenges include increased fraud and plagiarism, “predatory journals” and communicating research online before publication.

TAKE HOME MESSAGES “Mega journals” such as PLOS One or BMJ Open offer broad

interest and open access but are only reviewed for “quality” not “interest”.

Historical concerns about the quality of open access journals

are decreasing.

Surprisingly, associated social media campaigns have little impact on actual

article downloads, but sharing summaries of content is increasing exponentially.

Easily shareable “nuggets” (slides, videos, supplementary data) are key.

Sharing is happening on such a scale that copyright considerations are difficult to

track – less problematic for open access journals with Creative Commons

licensing.

Uptake on journal enhancement options has been lower than anticipated.

Lots of different models of peer review are now being used. Sharing reviews

between publishers is welcomed; ‘portable peer review’.

ORCID (http://orcid.org/) is increasing in popularity among researchers and

universities are engaging with new ways to rank academics, including

Snowball (http://www.snowballmetrics.com/).

Attendees reported that impact factors are still considered important:

but more so to academic authors than to the sponsor companies.

1.69%

8.47%

44.07%

45.76%

Unknown

Low

Medium

High

For pharma-funded studies, impact factors are of medium-high

importance to the sponsor

5.26%

2.63%

11.84%

80.26%

Unknown

Low

Medium

High

For pharma-funded studies, impact factors are of high

importance to academic authors


Novel

research

9a

HOT TOPIC Novel researchSixteen abstracts were accepted by ISMPP program committee for poster presentation at the meeting:

of these, five were chosen for oral presentation.


Continued . . .

TAKE HOME MESSAGES Acknowledgement of professional medical writing support in industry-

sponsored publications has become more transparent since GPP2.

However, only 12% of current papers follow GPP3 fully and include

name, qualification, institution and funding.

Medical writer qualifications are most often missed: only included in

29% of cases.

Dramatic improvements needed to meet the latest GPP3 guidelines!

A further analysis recommended after >12 months to assess whether

these GPP3 recommendations have been adopted in full.

TAKE HOME MESSAGES Articles with medical writing support are accepted in higher impact

journals than those written without such support.

This may be explained by enhanced quality of the article, improved

compliance with submission criteria, and provision of guidance to

authors on target journal selection.

Further research needed to examine the effect of medical writing

support on the impact of publications.

“Are we there yet? Does current practice in

acknowledging professional medical writing support

meet the requirements of GPP3?”

Sana Eljamel (Costello Medical Consulting)

“Does professional medical writing support increase the

impact of articles reporting randomized controlled trials?”

Will Gattrell (Oxford PharmaGenesisis,

Oxford Brookes University)

Novel

research

TAKE HOME MESSAGES Dissemination of primary data from negative trials appears generally

comparable to that of data from positive trials.

Time to publication and journal impact factor appeared to be

comparable for trials with negative vs positive results.

Negative trials appear more likely to be published open access than

positive trials.

More widespread reporting of registry identifiers in abstracts would

improve speed and certainty when searching for publications.

Searching Google Scholar was more effective than PubMed for

identifying primary publications using the CT.gov identifier.

TAKE HOME MESSAGES Analysis of data from the top 14 pharmaceutical companies.

Majority have publication policies that included a statement on

publication of all company-sponsored clinical trial data in the scientific

literature, regardless of outcomes.

Less than half included a statement on publication of non-company-

sponsored trials.

More than half did not specify a timescale for submitting trial

results for publication.

Over half of the policy statements have been updated

since 2014.

Need for companies to regularly update policies in line with guidelines.

9b




Continued . . .

“Reporting of positive and negative clinical trial results

in the age of mandatory clinical trial registration”

Bernard Kerr (Succinct Medical Communications)

“Benchmarking of publicly disclosed clinical trial

publication policies among pharmaceutical companies”

Daniel Portsmouth (Boehringer Ingelheim)

Novel

research

9c




TAKE HOME MESSAGES A better understanding of the factors that drive publication professionals to consider

specific journals could improve publication planning and aid discussions with authors.

This survey showed that the listing of a journal on PubMed is highly valued, either

because it is very widely used, or because survey respondents valued the credibility

of its published papers.

A defined target audience/short publication lead times also ranked highly.

Journals with a creative commons licence, but not those offering open access, deterred

survey respondents, suggesting that the potential for adaptation of content is a concern.

High publication charges and mandatory submission of the complete study protocol

were also deterants.

“Journal choice: Which factors do you value

when submitting a manuscript?”

Andrew Desson, MS, ISMPP CMPPTM (Shire),

Christopher Winchester, PhD (Oxford PharmaGenesis)

Corporate

Integrity

Agreements

(CIA)HOT TOPIC Corporate Integrity Agreements (CIA)This panel-led session included a fruitful discussion on CIA requirements and how they impact publication

planning and other activities, led by Christopher Rains (Shire) and Tom Grant (Complete HealthVision).

Currently more than 30 pharma companies work under a CIA.

CIAs typically last for five years and are applicable to any interactions with US physicians but the improvements

they demand have much greater longevity.

Implications on all activities, including publications.

Includes strict requirements on:

‒ Additional compliance training for anyone working on activities supporting products sold in the US.

‒ Standard operating procedures (SOPs) for various activities.

‒ Auditing of activities relating to engaging physicians to perform commercial and scientific services.

‒ Auditing of payments reporting.

TAKE HOME MESSAGES Medical communications agencies have a need for training in all SOPs

and publication management tools to help the pharma company meet

CIA requirements.

Labour intensive!

Limited time to get processes in place.

Effect on agency costs.


Copyright

HOT TOPIC CopyrightThe copyright session was led by Jesper Konradsen (Novo-Nordisk Healthcare) and

Jackie Marchington, PhD, ISMPP CMPP™ (Caudex).

Creative Commons (CC) licences allow anyone to reproduce and share material in any medium, under certain constraints.

There are three levels of licence type with different restrictions relating to use, adaptation, commercial use and data mining:

‒ CC BY licence only requires the user to give the full attribution.

‒ CC BY-NC licence requires that use must be “not primarily intended for or directed towards commercial advantage

or monetary compensation”.

‒ CC BY-NC ND licence specifies that adaptations of the materials may not be shared.

Open access delivered by journals is “gold” open access.

Authors may also choose a “green” open access route, allowing them to post the paper anywhere after 6 months of open access.

TAKE HOME MESSAGES Funding bodies may (and often do) stipulate open access as a condition of their support.

However, open access is often not offered for industry funded papers.

Frustrations have been reported regarding copyright being applied differently depending

on the user (academic vs industry).

Beware! Journals may charge more for open access to industry vs academics with the

same request.


Where

do we go

from here?

HOT TOPIC Where do we go from here?The conference ended with an interesting and controversial presentation from Vitek Tracz, Chairman of the

Science Navigation Group and founder of BioMed Central. Many limitations to the current model of publishing scientific data as peer reviewed articles in scientific/medical journals,

including: data delay (can be up to a year); acceptance of articles is based on effect on impact factor, which is a limited

metric; and lack of transparency in the peer review process (may be performed by competitors, unqualified people or

even fictitious reviewers).

F1000 (Faculty of 1000) was established as a publisher of services for scientists and clinicians to provide an alternative

to journals. Articles are given a quick cursory review and are published online within 5 days. Following a public review,

comments are addressed by the author and the final draft, if accepted, is published online. F1000 is a service provider

rather than a journal. Quality is still assessed but at the article level, not the journal level.

Impact factors are based on a very small percentage of journal articles but academics are still rated based on this

system. Urgent need to change the process!


Many interesting and controversial issues regarding medical publications

were raised during this ISMPP EU meeting – we look forward to continuing

these discussions during 2016 and beyond!

TAKE HOME MESSAGES Can we come up with something better than impact factors as a measure

of journal quality?

Should peer-review be transparent?

Should we be more interested in the quality of the article, not the journal?

Is the future of journals in question? Spirit Medical Communications

Adamson House

Towers Manchester

Manchester

M20 2YY

United Kingdom

Telephone: +44 (0)161 438 2350

Email: [email protected]

www.spirit-medcomms.com

spirit’s spotlight on ismpp! · “mega journals” such as plos one or bmj open offer broad...

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