Abstracts from the 12th Annual Meeting of ISMPP
Authors: A. Monpara; J. Hartung; Katherine S. Martinez; Karen Craun; C. Skobe; L. Mooney; Wendy Kopf; S. Rouhi
Year: 2016

s from the 12th Annual Meeting of ISMPP Analysis of publication timelines following clinical trial completion: Understanding industry trends Amy Monpara, Jessica Hartung, Katherine S. Martinez and Karen Craun MCPHS University, Boston, MA, USA Sanofi Genzyme, Cambridge, MA, USA Objective: Following the completion of clinical trials there is a gap between when evidence is generated and the time it is made publicly available. This analysis was conducted to evaluate manuscript publication timelines following completion of clinical trials in an effort to better understand industry trends. Research design and methods: Clinical trial data from ten top-selling oncology drugs were gathered using ClinicalTrials.gov. Phase 3 interventional studies with completed enrollment and posted results were included–studies for indications unrelated to oncology/hematology were excluded. Corresponding manuscript publication information was gathered–only primary manuscripts linked to the clinical trials were included. Clinical trials and manuscript publication data were recorded and analyzed using descriptive statistics. Results: A total of 105 clinical trials were identified and analyzed. Of these studies, 55 had publications linked to the trial. There was variation in time between primary completion date and manuscript publication date. Three studies had manuscripts published within 6 months of the primary completion date, 4 had manuscripts within 1 year. Fourteen studies had manuscripts published within the second year after primary completion. The largest portion of manuscripts, 24, was published over 2 years after primary completion. A positive trend was observed between study length and time to publication, number of patients and time to publication. Ten studies had a manuscript published prior to the primary completion date listed. Conclusions: The results suggest that clinical trial information is not fully made available to the general healthcare audience in a timely manner. This data warrants further analysis to address variables that are leading to a disparity in timelines, as a means to target and mitigate publication delays. Assessing industry-sponsored medical publications using alternative metrics Catherine Skobe, LaVerne Mooney, Wendy Kopf and Sara Rouhi Pfizer, Inc, New York, NY Adelphi Communications Inc, New York, NY Altmetrics.com, London, UK Objective: The objective was to benchmark the evolution of medical publications metrics from journal citations to social media/digital channels through an evaluation of attention indicators, using the Explorer for Institutions platform from Altmetric.com (AFI). An assessment of industry-sponsored published articles from one company was conducted. Research design and methods: We examined 783 industry–sponsored manuscripts published between Jan 1, 2013 and Dec 31, 2014. DOIs and PMIDs were used to search in AFI. Altmetric.com ranks level of attention by the volume of mentions, rather than the weighted Altmetric score, which is based on an algorithm. Articles that yielded any attention were included in the analysis (n = 413). We assessed the publications to determine the top 10 by level of attention, article type, therapeutic area, and product. Results: Eight of 10 articles with the highest number of mentions were published in the New England Journal of Medicine. The highest level of attention peaked between -1 to 2 months of publication. Of the 6 article types, primary and secondary manuscripts were most prevalent and demonstrated attention levels of 49.5% and 53.5%, respectively, based on a ratio of mentions: number of articles. Similarly, review articles demonstrated a 52.5% level of attention. The products with the highest ratios were product A (50.0%), product B (48.9%), and product C (53.8%). A qualitative assessment of mentions is ongoing. Conclusions: Journals that promote via social media published the most highly mentioned manuscripts. The ratio of mentions to number of articles was approximately 50% by article type or by product. While the number of mentions is of interest, we expect the qualitative evaluation to provide greater insight. Attenuating the role of impact factor by including high-quality publications when reporting publication metrics Miriam Gitler, Julliana Newman, Ian Hollingsworth, Nelson Olivier and Elizabeth Youngdale-Myers MedImmune, Gaithersburg, MD, USA AstraZeneca Ltd, Gaithersburg, MD, USA AstraZeneca Ltd, Innovative Medicines and Early Development, Manchester, UK AstraZeneca Ltd, Innovative Medicines and Early Development, Boston, MA, USA Objective: Impact factor (IF) is determined by dividing ‘‘number of citations generated’’ by ‘‘number of citable articles’’ published in a journal, the logic being that more important articles are cited more often and the journals with the most important articles have the highest IFs. However, a high IF for a journal does not guarantee that an individual article appearing in that journal is of high impact. As part of our internal publication metrics and reporting, we classified articles into 3 categories of journal IF: high impact (IF 15), high quality (HQ) (IF 5515) and other (IF55). However, this approach overlooked high-quality journals with low IFs, which include critical publications in specialized disciplines. Research design and methods: We solicited suggestions for high-quality journals with IF55 across experts in the AZ core disciplines to include in the publications metrics. These journals are considered to be the primary, highest impact journals for publications in their field. We reviewed and rated each suggestion for inclusion in the HQ list according to pre-established criteria, including number of articles that we published in that journal in past years, target audience, therapeutic area, etc. Results: We received 118 journal suggestions. This exercise was completed over a 3-month period. As a result, we selected 68 journals for inclusion in the HQ list. Conclusions: While impact factor remains a valued tool to evaluate the quality of journals and, by extension, articles published in those journals, focusing on IF alone excludes high-quality journals. Basing publication success and metrics on IF alone can be misleading and overlook important, impactful publications. Avoiding high-risk authors: Should Corporate Integrity Agreements recommend searching the Retracted Publications database? Luke C. Carey, Aruna Seth, Mark Woolley and Karen L. Woolley ProScribe–Envision Pharma Group, Sydney, New South Wales, Australia Consulting Solutions–Envision Pharma Group, Southport, Connecticut, United States University of Queensland, Brisbane, Queensland, Australia University of the Sunshine Coast, Maroochydore DC, Queensland, Australia Objective: Corporate Integrity Agreements (CIAs), which can address authorship practices, typically require sponsors to check if individuals have been debarred, but don’t yet recommend checking if these individuals have authored retracted publications. Authors with misconduct retractions can be serial offenders (highrisk authors). We investigated 1) the feasibility of cross-matching debarment and retracted publications lists, and 2) how well debarment searching could detect retracted authors. Research design and methods: For this quantitative and qualitative assessment, we exported (11/08/2015) data from the US Food and Drug Administration (FDA) Debarment List and the MEDLINE Retracted Publications database (both freely ! 2015 Taylor & Francis www.cmrojournal.com Abstract S5 accessible). Every debarred individual was checked against all authors of all retracted publications. Potential matches were further investigated to ensure cross-match validity. Searching time was recorded. A case study was conducted on the cross-matched author with the highest retraction record. Results: Cross-matching was feasible; each debarred author could be checked within 5 minutes. The FDA Debarment List (n = 139 entries; US focus) was less comprehensive than the Retracted Publications database (n = 4013 entries; global focus). There were only 2 (1.5%) matches between debarred individuals and retracted authors; both retracted authors were serial offenders for publication misconduct. The case study showed debarment didn’t occur until 2 years after 18 publications had already been retracted. Conclusions: The Retracted Publications database, more global and 30-fold larger than the FDA Debarment List, could provide sponsors and agencies with a free, practical, timely, relevant, and comprehensive way to help avoid high-risk authors. Future CIAs, as well as Good Publication Practice guidelines and company policies, could consider recommending a Retracted Publications search before author engagement. Acknowledgments: The authors acknowledge project management support from Dr Thao Le (Envision Pharma Group). Can Centers for Medicare & Medicaid Services (CMS) reporting verify disclosures? Melanie Blanchard, Gina Fusaro, Jill Sanford, Debbie Wolinsky, Dawn Martucci, John McGuire and Suzanne Van de Water MediTech Media, Atlanta, GA Celgene Corporation, Summit, NJ MediTech Media, Hamilton, NJ Objective: Disclosure reporting is unstandardized. Physician payments are reported to CMS under the Sunshine Act. We compared disclosures with CMS reporting to determine if the database could verify disclosures. Research design and methods: Disclosures from 57 US physicians from 4Q2014 3Q2015 were compared to the 2014 database. Consistency was evaluated in 4 categories: Consultant/advisor, speaker, honoraria, and research. Pearson’s correlation was used to evaluate the effect of number of CMS-reported relationships and number of mismatches. Results: 9% of disclosures matched CMS information across all categories. Consistency of honoraria reporting occurred most often (74%); in each instance no payment was reported. The mean number of affiliations per physician was 3.7 by both CMS (range 1–12) and disclosures (range 0–45);