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Sponsored Reviews and Supplements: Current Approaches and Future Trends Elizabeth Crane Senior Manager, Medical Publications, Astellas Pharma Global Development, Inc.

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Sponsored Reviews and Supplements: Current Approaches and Future Trends

Elizabeth Crane, Astellas Pharma Global Development, Inc. Craig Smith, Elsevier Stephen Jones, ACUMED

Introduction

• Industry-sponsored reviews and supplements

are under scrutiny

• Potential bias, educational usefulness, and

compliance issues surrounding distribution are of concern

• No definitive guidelines or best practices have

been published

Objectives

• To assess current and future policies and

process for review article and supplement development

– Publication planning professionals (PPPs) – Journal and supplement editors

• To assess similarities in policies and practices

between PPPs and editors

Methods

• Two email surveys were issued in 1Q 2010

– 21-item questionnaire for publication planning professionals

(n=43)

• Review types
• Scope of reviews
• Internal development processes
• Future trends

– 13-item questionnaire for journal editors (n=31) and

supplement editors (n=26)

• Journal requirements and policies
• Future trends

Sample of journals responding to survey

• Biological Psychiatry
• The American Journal of

Medicine

• The American Journal of

Cardiology

• Transplantation Proceedings
• Annals of Epidemiology
• Journal of Cardiac Failure
• Journal of Pain and

Symptom Management

• American Heart Journal
• The Lancet
• Journal of the American

Academy of Dermatology

• Journal of Asthma and

Clinical Immunology

• The Journal of Pediatrics
• Aesthetic Surgery Journal
• The American Journal of

Preventive Medicine

• Pain Management Nursing
• Geriatric Nursing

Publication policies for reviews and supplements are common

• Policies covering reviews were more frequent than policies for

supplements (82.9% vs 65.7%, respectively)

• Over two-thirds of respondents noted that a needs assessment

was required, prior to initiation of a review or supplement

• Medical affairs and publications departments appear to drive the

needs assessment

The majority of companies implement a review process

• 91.4% (32/35) of respondents implement a formal review process for

reviews and supplements

• Of the respondents implementing a formal review, the departments most

commonly included in the process were

– Medical (56%) – Publications (56%) – Regulatory affairs (50%) – Biostats (47%)

• Departments most likely to undertake full content reviews included

– Medical (41%) – Publications (34%) – Regulatory affairs (25%)

• 40% of respondents noted that marketing departments undertook

courtesy review

Who drives topics for reviews/supplements? Perceptions of PPPs

Author suggestions Advisory board findings Gap/literature analysis Steering Committee Symposia content Agency Suggestions Other 20 40 60 80 100 % of responders (number) 82.4% (28) 73.5% (25) 70.6% (24) 61.8% (21) 38.2% (13) 23.5% (8) 20.6% (7)

Who provides financial support for supplements?

1: Pharmaceutical industry

–

92% of respondents indicated most common form of support

2: Government agencies 3: Medical device and equipment companies 4: Non-profit organizations

Generation of supplement titles – feedback from editors

Agency and pharma suggestions Symposia proceedings Author/editorial board suggestions Gap/literature analysis Other Advisory board findings Steering committee 20 40 60 80 100 % of responders (number) 1.7% (1) 3.5% (2) 8.8% (5) 24.5% (14) 24.5% (14) 33.3% (19) 3.5% (2)

Which of the following review types are accepted?

• 64% of journals over the last 12 months

have not published a single unsolicited review

• 75% of journals will accept solicited and

unsolicited reviews

Non-solicited Invited/solicited Systematic Narrative 20 40 60 80 100 % of responders (number) 62.5% (15) 75.0% (18) 75.0% (18) 41.7%(10) 20 40 60 80 100 % of responders (number) 1−3 >5 3−5 4.5% (1) 31.8% (7) 63.6% (14) 0% (0)

Factors driving the perception amongst PPPs that reviews are difficult to publish

• 83% of respondents felt that publication of reviews was becoming more

difficult

–

Acceptance rate was noted as the driving factor

Reduced journal acceptance rate Perceived as marketing tools Authors are now less inclined to accept writing support Authors are now less inclined to accept industry suggestions Other Authors are now less inclined to accept financial support 20 40 60 80 100 % of responders (number) 3.4% (1) 17.2% (5) 20.7% (6) 41.4% (12) 62.1% (18) 72.4% (21)

Factors driving the perception amongst PPPs that supplements are difficult to publish

• 66% of respondents felt that publication of supplements was becoming

more difficult

– The majority felt that supplements are perceived as marketing tools

Perceived as marketing tools Reduced journal acceptance rate Authors are now less inclined to accept industry suggestions Authors are now less inclined to accept writing support Other Lack of citation Authors are now less inclined to accept financial support 20 40 60 80 100 % of responders (number) 5% (1) 9% (2) 14% (3) 27% (6) 32% (7) 41% (9) 82% (18)

Journal/supplement disclosures: current needs

• Author conflict of interest (reviews): 95.7%
• Medical writing support: 91.3%
• Require medical writers to be included in author list if

they meet ICMJE requirements: 63.6%

• Sponsorship: 91.3%

96.2% of journal supplements are peer reviewed

PPPs respondents felt that sponsorship of reviews and supplements would fall over the next 5 years

Sponsor fewer supplements Sponsor fewer reviews Remain as current Sponsor systematic reviews only Move to joint-sponsorship with

• ther companies

No longer sponsor reviews Other 20 40 60 80 100 % of responders (number) 11.4% (4) 11.4% (4) 11.4% (4) 17.1% (6) 20.0% (7) 45.7% (16) 54.3% (19)

How will the scope of supplement and review publishing change in the future? Feedback from editors

More focus on disease state Will not change More focus on product class Multiple sponsorship More focus on individual products 20 40 60 80 100 % of responders 0% 5% 25% 55% 20 40 60 80 100 % of responders 0% 46.2% 19.2% 30.8%

Reviews Supplements

5% 46.2%

In the future, PPPs believe that sponsored publications may shift away from focusing on individual products

More focus on disease state Will not change More focus on product class More focus on individual products 20 40 60 80 100 % of responders (number) 3.4% (1) 31.0% (9) 31.0% (9) 34.5% (10) 20 40 60 80 100 % of responders (number) 5.9% (2) 26.5% (9) 35.3%(12) 61.8% (21)

Reviews Supplements

Implications

• In absence of uniform requirements, editors and

sponsors are self-governing

• Scientific need appears to drive sponsorship of

concepts originating from authors/experts and gap/literature analysis

• Expect fewer sponsored reviews and supplements,

increased focus on disease state

– Potential trend for supplements with multiple sponsors – Society and journal initiated gap analysis

• Authors desire to work independently from industry

and agencies may be additional factor in decrease of sponsored reviews and supplements