DISCLAIMER: The content of this presentation may not accurately reflect current legal or regulatory requirements, industry standards, or professional best practices. ISMPP is providing access to this presentation as a member service only, and does not recommend or condone the use of this presentation in whole or in part to support legal or professional decisions or practices. Sponsored Reviews and Supplements: Current Approaches and Future Trends Elizabeth Crane Senior Manager, Medical Publications, Astellas Pharma Global Development, Inc.
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 The Lancet Biological Psychiatry • • • Journal of the American • The American Journal of Academy of Dermatology Medicine Journal of Asthma and The American Journal of • • Clinical Immunology Cardiology The Journal of Pediatrics Transplantation Proceedings • • Aesthetic Surgery Journal Annals of Epidemiology • • • The American Journal of • Journal of Cardiac Failure Preventive Medicine • Journal of Pain and Pain Management Nursing Symptom Management • • Geriatric Nursing • American Heart Journal
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 82.4% (28) Author suggestions Advisory board findings 73.5% (25) 70.6% (24) Gap/literature analysis Steering Committee 61.8% (21) Symposia content 38.2% (13) Agency Suggestions 23.5% (8) Other 20.6% (7) 0 20 40 60 80 100 % of responders (number)
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 33.3% (19) suggestions 24.5% (14) Symposia proceedings Author/editorial board 24.5% (14) suggestions 8.8% (5) Gap/literature analysis 3.5% (2) Other Advisory board findings 3.5% (2) Steering committee 1.7% (1) 0 20 40 60 80 100 % of responders (number)
Which of the following review types are accepted? • 75% of journals will accept solicited and • 64% of journals over the last 12 months unsolicited reviews have not published a single unsolicited review Non-solicited 0 63.6% (14) 75.0% (18) 1 −3 Invited/solicited 31.8% (7) 75.0% (18) Systematic >5 62.5% (15) 4.5% (1) 3 −5 Narrative 41.7%(10) 0% (0) 0 20 40 60 80 100 0 20 40 60 80 100 % of responders (number) % of responders (number)
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 72.4% (21) acceptance rate Perceived as 62.1% (18) marketing tools Authors are now less inclined to accept 41.4% (12) writing support Authors are now less inclined to accept 20.7% (6) industry suggestions Other 17.2% (5) Authors are now less inclined to accept 3.4% (1) financial support 0 20 40 60 80 100 % of responders (number)
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 82% (18) marketing tools Reduced journal 41% (9) acceptance rate Authors are now less inclined 32% (7) to accept industry suggestions Authors are now less inclined 27% (6) to accept writing support Other 14% (3) Lack of citation 9% (2) Authors are now less inclined 5% (1) to accept financial support 0 20 40 60 80 100 % of responders (number)
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 54.3% (19) supplements Sponsor fewer reviews 45.7% (16) 20.0% (7) Remain as current Sponsor systematic 17.1% (6) reviews only Move to joint-sponsorship with 11.4% (4) other companies No longer sponsor 11.4% (4) reviews Other 11.4% (4) 0 20 40 60 80 100 % of responders (number)
How will the scope of supplement and review publishing change in the future? Feedback from editors Reviews Supplements More focus on 30.8% 55% disease state Will not change 46.2% 25% More focus on 5% 19.2% product class Multiple sponsorship 5% 46.2% More focus on 0% 0% individual products 0 20 40 60 80 100 0 20 40 60 80 100 % of responders % of responders
In the future, PPPs believe that sponsored publications may shift away from focusing on individual products Reviews Supplements More focus on 34.5% (10) 61.8% (21) disease state Will not change 31.0% (9) 35.3%(12) More focus on 31.0% (9) 26.5% (9) product class More focus on 5.9% (2) 3.4% (1) individual products 0 20 40 60 80 100 0 20 40 60 80 100 % of responders (number) % of responders (number)
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
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