市場調査レポート

医学論文プランニング:透明性を促進するための従来型・新興チャネルの統合

Medical Publications Planning: Uniting Traditional and Emerging Channels to Foster Transparency

発行 Cutting Edge Information 商品コード 231274
出版日 ページ情報 英文 285 Pages
納期: 即日から翌営業日
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医学論文プランニング:透明性を促進するための従来型・新興チャネルの統合 Medical Publications Planning: Uniting Traditional and Emerging Channels to Foster Transparency
出版日: 2014年06月30日 ページ情報: 英文 285 Pages
概要

当レポートでは、ライフサイエンス産業において更なる透明性を目指すための医学論文のグループ戦略、リソース、スケジュールおよび目標を探るベンチマーク・ベストプラクティスを提供しています。

第1章 論文ニーズに対応する構造・スタッフィング要素の開発

  • 世界、企業および国レベルのチームにわたる構造・スタッフィングメトリクスの分析
  • 本章のメリット
  • 各種データ
    • 論文グループの構造
    • 論文チームのスタッフィング:アウトソースvs.社内
    • コンプライアンスのトレーニング

第2章 医学論文をサポートする適性な予算・外部リソース

  • 論文チームへの予算配分・アウトソーシングの実行・ROI評価手法
  • 本章のメリット
  • 各種データ
    • 論文チーム予算
    • アウトソーシング
    • 論文チームのパフォーマンスメトリクス

第3章 医学論文戦略の開発:スケジュール構築・コーディネート活動・ジャーナルタイプの標的化

  • ジャーナルの選定およびアウトプットレベル予測を含めた、企業による論文プランニングへのアプローチ
  • 本章のメリット
  • 各種データ
    • 原稿の作成
    • 理論の開発
    • ジャーナルの選定
    • 格付け・自己評価

第4章 増大するメリット・課題

  • 論文の透明性
  • 本章のメリット
  • 各種データ

第5章 医学論文チームのプロファイル

  • 医学論文12チームのプロファイル
    • あらゆる企業規模(上位20社、上位50社、小規模企業、医療機器)
    • チームへのフォーカス(企業規模、企業レベルのビジネスユニット、国レベル)
    • チームのアウトプットレベル
  • 本章のメリット
  • 各種データ
    • 企業背景・製品情報
    • 医学論文のスケジュール
    • 製品特有の論文活動
    • 製品ライフサイクル段階あたりの論文数

付録

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目次
Product Code: PH201

REPORT KEY FINDINGS

  • Institute publications group structures that foster robust interteam communication.
  • Implement regular training to foster compliant medical publications teams.
  • Track performance metrics to showcase medical publications teams' strategic value.
  • Employ proactive transparency practices to benefit both the company and the public.
  • Consider open access journals as an option for publishing low-impact trials.

WHY CLIENTS NEED THIS REPORT

  • Prepare publications teams for an increasingly transparent industry setting.
  • Understand the risks and benefits of increased openness with the public and scientific/medical community.
  • Benchmark publications strategies against teams of similar size, responsibility and output.
  • Mitigate the effects of the Sunshine Act as it pertains to publications authors/ investigators.
  • Avoid a corporate integrity agreement - or be better prepared to enter one.
  • Effectively allocate budgets for publications teams, ensuring that their resources match their output levels.
  • Demonstrate value and obtain sufficient resources to enable strategy setting.
  • Select vendors that best-fit your company's publications needs.
  • Set meeting schedules that drive publications teams to meet - and even exceed - their goals.

OVERALL MESSAGES

  • 1. Be more transparent than ever : Transparency is of growing importance to both the pharmaceutical industry and scientific community. New methods (open access journals, online portals, etc.) have emerged that help companies release data.
  • 2. Use hard metrics to best prove publication team value : Performance metrics -- such as manuscript/abstract volume, number of citations and acceptance rates -- help prove the full value of publications teams.
  • 3. Train writers and scientists for compliance : Regular compliance training helps ensure a transparent publications team with little chance of additional regulatory requirements.

REPORT FEATURES

This report's five (5) chapters contain benchmarks and best practices exploring publications group strategy, resources, timelines and goals as teams navigate the life sciences industry's move toward greater transparency.

Highlights include:

  • Benchmarks, case studies and diagrams showing publications team structure, staffing, budgets and spending.
  • Detailed data showing publications task and workload distribution between in-house and external groups.
  • In-depth discussion and data showing publications group performance metrics measured.
  • Extensive benchmarks showing number of manuscripts and abstracts produced per year for 2012 through 2014.
  • Key recommendations for choosing the best vendors to perform publications tasks.
  • Comprehensive guidelines for choosing which journals to submit to - including new channels such as open access.
  • Impact ratings of new ICMJE guidelines and corporate integrity agreements (CIAs) on publications processes.
  • Profiles/infographics of 12 publications teams, allowing snapshots of team strategies, output and resources.

Data are split, where relevant:

  • Level of team responsibility:
    • Global
    • Corporate-level business unit
    • Country-level
  • By Output level:
    • High-output
    • Low-output
  • By company size
    • Top 20
    • Top 50
    • Small
    • Device

PRIMARY AUDIENCE

  • Executives (VPs, directors, managers) of publications, medical publications, medical information, medical communications, medical affairs, medical writing, medical science
    • Related roles: MSL, clinical staff, lead investigators (often serve as authors), data analysts / biostatisticians (may prepare data for analysis and publication), knowledge management, medical education
    • Related functions: clinical, R&D, marketing
  • LinkedIn groups for:
    • Medical writers, medical affairs, MSL, physician outreach
    • Other publication groups, including ISMPP (International Society of Medical Publication Professionals). Many pharma executives are members.
  • PPs/DLs:
    • PH67, 104, 163 : previous Cutting Edge Information medical publications reports
    • PH184 : Medical Affairs: Resource Allocation for the Global Marketplace
    • PH124 : Evolving Medical Information Call Centers: Performance Measurement and Process Improvement
    • PH167 : Medical Information Teams and Call Center Management

REPORT DEFINITIONS

Data Split

This study divides surveyed companies into three categories, based upon extent of team responsibility:

  • Companywide Teams : These teams are responsible for managing company publications across all regions and therapies.
  • Corporate-Level Business Unit Teams : These teams manage publications for specific therapeutic areas, brands, or general regions (Europe, North America, South America, Asia, etc.).
  • Country-Level Teams : These teams manage publications for a specific country.

This study also categorizes survey respondents by their annual publication output level:

  • A high-output medical publications team produces more than 20 manuscripts annually and/or a combination of manuscripts and abstracts of 50 or more.
  • A low-output medical publications team produces fewer than 20 manuscripts annually and/or a combination of manuscripts and abstracts of 50 or fewer.

Journal Evaluation Criteria

Several criteria used to evaluate the influence of a particular medical journal require calculations. One such criterion is listed below:

  • Impact Factor : A measure of the number of times an average paper in a particular journal is referred to. The Impact Factor of journal J in the calendar year X is the number of citations received by J in X to any item published in J in (X-1) or (X-2), divided by the number of source items published in J in (X-1) or (X-2).

PAIN POINTS AND SOLUTIONS

Streamline Publications Processes through Structure and Staffing:

  • Which structure best suits our company's publications strategy?
  • Which functions provide optimal publications support?
  • Why are dedicated teams advantageous to publications?
  • How can companies keep teams abreast ofchanging regulations?

Reap Benefits of Increased Transparency:

  • What are the advantages of transparency?
  • How do companies promote and enforce transparency internally?
  • How can companies prevent or mitigate the effects of a corporate integrity agreement?

Right-Size Publications Budgets and External Support:

  • What are publications teams' annual budgets?
  • How do publications teams meet increased output demands?
  • How do publications teams demonstrate value to key stakeholders?

Craft a Superior Publications Strategy

  • What factors influence publications strategy?
  • How can teams strengthen communications among publications-focused groups?
  • How can teams improve journal selection?
  • How many abstracts and manuscripts are publications teams producing?

QUICK FACTS BY THE NUMBERS

  • 61% -- Average percentage of surveyed companies that consider physician education a top publication priority
  • 58% -- Average percentage of surveyed companies that consider announcing clinical trial findings a top publication priority
  • 85% -- Average percentage of surveyed companies publishing in large, traditional journals
  • 73% -- Average percentage of surveyed companies publishing in open access journals
  • 23 -- Average number of manuscripts that surveyed companies submitted for publication in open access journals
  • 6 -- Average number of manuscripts that surveyed companies submitted for publication in open access journals

REPORT NOTABLE QUOTABLES

  • "OUR ULTIMATE GOAL AND THE IDEAL IS TO REALLY NOT OUTSOURCE ANYTHING - TO DO ALL OF THE WORK OURSELVES. WE JUST DON'T HAVE THE RESOURCES AND THE TIME THAT IT TAKES."
    - DIRECTOR OF PUBLICATIONS PLANNING, TOP 20 COMPANY
  • "AS VENDORS, WE COORDINATE A LOT OF PUBLICATIONS MEETINGS. BEFORE THE MEETING, WE MIGHT PUT TOGETHER A CONCEPT BRIEF - LESS THAN ONE PAGE - OF THINGS THAT WE THINK ARE IMPORTANT TO GET AUTHORS' REACTIONS. YOU WANT TO GET A DIALOG GOING; YOU WANT THE WRITER TO EXPRESS SO YOU CAN FIND A WRITER THAT IS ABLE TO DO THAT."
    - MEDICAL PUBLICATIONS CONSULTANT, TOP 20 COMPANY
  • "WE WANT THE DATA TO BE UNDERSTOOD. IF PEOPLE CAN TAKE THE DATA AND ADVANCE MEDICINE, INCLUDING EVEN OUR COMPETITORS, WE THINK THAT'S A GOOD THING. AT THE END OF THE DAY, WE'RE ALL PATIENTS."
    - DIRECTOR OF PUBLICATIONS PRACTICES, TOP 20 COMPANY
  • "NORMALLY, IT'S NO PROBLEM TO GET OUR BUDGET. IT'S AN ONGOING CONVERSATION. YOU NEED TO EXPLAIN EVERY TIME: IF YOU DELAY PUBLICATIONS WITH SMALLER BUDGETS, YOU DELAY EVERYTHING."
    - SCIENTIFIC KNOWLEDGE MANAGER, TOP 20 COMPANY

Table of Contents

CHAPTER BENEFITS AND METRICS BREAKDOWN

Chapter 1: Developing Structure and Staffing Elements to Address Publications Needs (Author: Sarah)

This chapter provides a breakdown of structure and staffing metrics across global, corporate and country-level teams. Surveyed companies report a wide array of preferences for their publications team structures. While centralized structures may be advantageous for large teams, smaller groups may benefit from the increased autonomy of a more decentralized approach. Company size and team responsibility may also shape the number of publications groups necessary to support activities. However, regardless of the publications structure companies adopt, teams benefit from conducting regular compliance sessions to stay abreast of regulatory trends.

Chapter Benefits

  • Communicate with all in-house and external parties to track clinical trial progress, ensure data availability, and uphold publication deadlines.
  • Use dedicated personnel to produce more publications faster.
  • Develop SOPs that include frequent compliance training to remain ahead of the regulatory curve.

Chapter Data

62 charts detailing medical publications group structure, oversight, outsourcing and staffing trends. Throughout this chapter, data are broken down by type (companywide, corporate-level business unit and country-level) and by publications output level (high output and low output).

Publications Group Structure

  • Preferred publications group structures (e.g., centralized, decentralized by therapeutic area or country, therapeutic area or brand)
  • Structure of companies' dedicated publications group, by team type
  • Function overseeing publications at companies without dedicated publications teams, by team type
  • Functions involved in publications processes
  • Number of publications groups, by output level
  • Percentage of teams with dedicated publications groups (all high-output and low-output teams)
  • Level of executive in charge of publications, by team type

Publications Team Staffing Outsourced vs. In-House

  • In-house publications team staffing by company size (top 20, top 50, small and device companies) and by team type
  • Outsourced publications team staffing by company size (top 20, top 50, small and device companies) and by team type
  • Percentage of change for companies' in-house (outsourced) publications team staffing from year to year (2011-14)

Compliance Training

  • Number of hours dedicated to compliance training for publications teams, by team type
  • Percentage of teams that provide compensation for publications compliance training, by team type

Chapter 2: Right-Sizing Budgets and External Resources to Support Medical Publications (Author: Victoria)

This chapter focuses on allocating budgets, outsourcing practices and ROI evaluation methods for publications teams of varying responsibility and output levels. To effectively develop and publish the manuscripts, abstracts and other deliverables that drive medical communication, medical publications require adequate resources. Companies must consider several factors, including team output, to determine publications resources. To maximize their resources, teams look to vendors to take on a range of activities - from data analysis to manuscript and abstract development. Publications teams should also track performance metrics to highlight their strategic value and win senior management buy-in.

Chapter Benefits

  • Increase budgets when possible to keep up with increased publications demands.
  • Leverage the expertise of outsourced vendors to efficiently manage influxes of clinical trial data.
  • Adjust medical publications outsourcing practices to meet Sunshine Act requirements.
  • Provide a complete picture of publication team efficacy, using hard and soft metrics.

Chapter Data

50 charts detailing medical publications group spending and budgets. Throughout this chapter, data are broken down by type (companywide, corporate-level business unit and country-level) and by publications output level (high output and low output).

Publications Team Budgets

  • Annual medical publications team budgets, by team type, output level and company size (top 20, top 50, small pharma and device)
  • Percentage change in publications team budget from 2013 to 2014, by company size and by company type
  • Percentage of budget dedicated to specific activities for high-output (low-output teams, by team type:
    • Manuscript development
    • Manuscript publication
    • Compliance training
    • Poster development
    • Press release publications
  • Diagram of medical publications team funding process at Top 20 company with a high-output team

Outsourcing

  • Percentage of workload outsourced, by company size, team type and output level
  • Percentage of companies outsourcing specific activities and the percentage of workload outsourced for these activities:
    • Data analysis
    • Manuscript writing
    • Abstract writing
    • Poster development
    • Editing
    • Quality assurance and quality control

Publications Team Performance Metrics

  • Performance metrics measured, by team type

Chapter 3: Developing a Medical Publications Strategy: Establishing Timelines, Coordinating Activities and Targeting Journal Types (Author: Sarah)

Chapter 3 examines companies' approaches to publications planning, including journal selection and projected output levels. Building a robust publications process starts with mapping out strategy as soon as possible. The earlier that companies meet with all publications-focused groups, the earlier companies can develop and implement their publications plans. Constant communication helps global, single business unit and country-level teams alike to track publications' progress. Communication also helps teams overcome any challenges that may arise - from short timelines to resource constraints. Moreover, frequent publication meetings can help teams develop a targeted approach to journal selection and submission.

Chapter Benefits

  • Consider product lifecycle when prioritizing among publications activities.
  • Research target journals prior to submission to increase odds of acceptance
  • Identify and weigh key criteria to select the best publications channels:
    • Study features
    • Audience needs
    • Ratings of journal selection factors
  • Track publication patterns from 2012 to 2014 to keep pace with changes in the industry and benchmark publications output.
  • Effectively leverage internal and external staff to build and support publications strategy.

Chapter Data

65 charts detailing aspects of medical publications strategy, including number of publications produced and journal selection. Throughout this chapter, data are broken down by type (companywide, corporate-level business unit and country-level) and by publications output level (high output and low output).

  • Companies' objectives for medical publications strategy, by team type
  • Functions involved in medical publications strategy, by team type
  • Frequency at which medical publications teams and involved functions meet, by team type and output level

Manuscript Development

  • Number of manuscripts produced and published
    • by year (2012, 2013, 2014)
    • by team type (companywide, for one corporate business unit or country)
    • by team size and output level (large and small high- and low-output teams)

Abstract Development

  • Number of abstracts developed:
    • per year (2012, 2013, 2014)
    • by team type (companywide, for one corporate business unit or country)
    • by team size and output level (large and small high- and low-output teams)
  • Percentage of abstracts developed by high-output (low-output) teams with companywide (corporate business unit, country level) responsibility, by FTE type
    • In-house staff
    • Contract medical writers
    • Investigators
    • Other

Journal Selection

  • Perceived importance of the following factors in selecting a journal, from least important to most important (by team type):
    • Generate immediate action
    • Impact factor
    • Cited half-life
    • Rank in journal citation report
    • Cost
    • Circulation data
    • Size of publication
    • Peer review
    • Rank of publication
    • Age of publication
    • Past experience
  • Percentage of companies publishing research in specific journal types:
    • Large traditional journals
    • Specialty journals
    • Open access journals
    • Small traditional journals
    • Online journals
    • Other types (e.g., newsletters, posters, meeting abstracts)
  • Number of contributions to these journal types in 2013 (by team type and output level)

Ratings and Self-Assessments

  • Ratings of challenges for medical publications teams, by team type
    • Receiving funding for additional publications activities
    • Communicating effectively with end users
    • Understanding the audience
    • Overcoming functions working in silos
    • Winning senior management buy-in
  • Companies' self-assessment ratings of their publications efforts, by team type

Chapter 4: Benefits and Challenges of Increasing

Transparency Across Publications (Authors: Victoria and Sarah)

Chapter 4 delves into how the industrywide push toward clinical data transparency is shaping companies' publications strategies. Several factors are causing an upswing in pharma companies' transparency needs. External forces are driving increased trial publication and clarity regarding authorship. Additionally, upper management is realizing the benefits that full data disclosure can bring to both the company and the public. This chapter explores the factors leading to greater transparency in pharma, as well as the ways in which companies achieve it and its effects on the industry.

Chapter Benefits

  • Build public trust and facilitate better health outcomes by developing SOPs that target clinical data transparency.
  • Track upcoming regulations and initiatives to develop robust publications SOPs.
  • Adhere strictly to multiple sets of guidelines for optimal transparency.
  • Strengthen and formalize publications SOPs to avoid - or lessen the impact of - corporate integrity agreements (CIAs).

Chapter Data

14 charts showing the impact of the pharmaceutical industry's move toward increased transparency. Throughout this chapter, data are broken down by type (companywide, corporate-level business unit and country-level) and by publications output level (high output and low output).

  • Percentage of companies that follow ICMJE guidelines (by team type)
  • Impact ratings of 2013 changes to ICMJE guidelines
  • Percentage of companies with an SOP in place requiring publication of all trials
  • Percentage of companies with a CIA that affects publications activities (by team type)
  • Ratings showing CIAs' impact on publications activities (by team type)
  • Number of months required to implement publications CIA
  • Percentage of companies requiring additional staffing to support CIA (by team type)
  • Number of FTEs added to support CIA

Chapter 5: Medical Publications Team Profiles (Author: Victoria)

This chapter presents 12 medical publications team profiles. Profiles span all company sizes (Top 20, Top 50, small and medical device), team focus (companywide, corporate-level business unit and country level) and team output level.

Chapter Benefits

  • Compare your medical publications team's resources and strategy against one of a similar size/type.
  • Consult these profiles' timeline and output data to establish or improve your publications team strategy.

Chapter Data

Each profile contains the following components:

Company Background and Product Information

  • Company size
  • Publications group focus
  • Publications output level
  • Spotlight on a specific product (e.g., small molecule drug, medical device, biologic)
  • Whether publications team tracks performance metrics on this product

Medical Publications Timeline

Data show when during the product lifecycle medical publications teams perform specific publications activities:

  • Begin planning publications strategy
  • Publish first manuscript
  • Begin tracking performance indicators
  • End tracking performance indicators
  • Conclude publications team involvement

Product-Specific Publications Activities

Data show whether manuscripts were submitted or published in specific journal types:

  • Large traditional journals
  • Small traditional journals
  • Open access journals
  • Specialty journals
  • Online journals
  • Nontraditional journals
  • Other publications

Number of Publications per Product Lifecycle Stage

Data show the number of manuscripts and abstracts published per lifecycle stage, from pre-clinical development to 5+ years post-launch.

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