Collaborative efforts can pose an array of challenges. Parties sometimes find themselves without a clear sense of who can make binding decisions regarding publication, or who has legal authority to build upon the work and make improvements.
- Examine how effective partnerships can be initiated and maintained at the publication team level
- Discuss challenges with internal and external stakeholders collaboration
- Review compliance considerations
- Define the framework for collaborative research
Plain language summary (PLS) writing, and contents play a key role in communicating clinical research information and outcomes broadly to a wider audience - which may include patients, study participants, caregivers, general public, media, healthcare providers and other researchers. However, there are few guidelines and no consistency of approach to the PLS initiative, which leaves questions regarding ideal format and presentations.
- Review the challenges with writing PLS (simplistic vs. simplified)
- Optimize readability and format of PLS
- Design infographics to simplify data and information
- Grasp the differences between PLS in a clinical trial report and a publication
- Examine the requirements of the EU regulations for CSR and Protocol Summary or Synopsis
- Set and achieve best practices for PLS to reach the target audience
- Kim EdwardsPhD, Associate Director, Medical WritingCenter for Information & Study on Clinical Research Participation (CISCRP)
- Harold M. SilvermanPharm.D., Lead Science Writer and SME, Informed Consent and Plain Language SummaryGSK Vaccines
- Malgorzata Eliza Sztolsztener, PhDClinical Trial Transparency Associate DirectorASTRAZENECA
- Gissoo DeCotiisHead of Global Advocacy, OncologyDAIICHI SANKYO
- Kathleen OrmistonGlobal Head of Trial TransparencySANOFI
Publication and communication planning can be enriched through the use of various strategies and approaches to optimize the success of publications. Early planning is required to prepare trial results for publication to ensure that important scientific data are communicated to the appropriate audience in a timely manner.
- Overcome the challenges of working with busy KOLs
- Discuss how to appropriately target journals based on intended audience
- Pinpoint the importance of gap analyses to better inform and advance publication planning
- Take a look at how to improve the publication development process to make it more transparent
- Use of publication metrics to track and improve on publication success, and optimizing publication titles
The multitude of target audiences should be kept in mind when developing content and publication for medical devices end user documentation such as IFU, Package Inserts, Technical Data Sheet and product labeling.
- Clarify the importance of simplified and accurate information to ensure users safety
- Steps to ensure compliance and considerations for various regulations including from the FDA, IVDR, MDR
- Examine the skills and knowledge most essential for content development and publication success
Initiatives designed to improve diversity, equity, and inclusion have become top priority across the life science industry. Within the publication space, there has been increased emphasis on taking steps to ensure that the research reflects and amplifies diverse voices from authorship on down to data dissemination plans.
- Address the challenges of establishing DEI in medical research and publishing
- Examine the medical communicator’s role in ensuring DEI
- Tactics to bring diversity across the publication process and gain equity and equality in representation from start to finish
- Chandra C. AbbottPh.D., Senior Director and Head, Scientific Communications and Operations- Medical AffairsBiohaven
- Valerie PhilipponHead, Scientific Communications & Managed Access - Rare DiseasesUCB
- Behtash BahadorMS, Director, Health LiteracyCenter for Information & Study on Clinical Research Participation (CISCRP)
About 50% of abstracts presented at conferences get published as full manuscripts in peer reviewed journals. Scientific manuscripts must be thorough, logically presented, factual and adhere to a specific language and format to communicate the results to the scientific community whilst adhering to ethical guidelines.
- Walk through the process of manuscript writing
- Recognize what your audience will find easily understandable
- Discuss proven strategies to address and resolve KOL conflicts
- Follow guidelines to ensure all participants are credited fairly
- Highlight challenges of reviewing the manuscript
- Comply with ethical guidelines, including Good Publication Practice-3 (GPP3), ICMJE and CONSORT
- Interactive case studies, including value proposition and communications
- Principles, with an emphasis on ``fair balance``
- Practice, with an emphasis on study design, biostatistics, and ``humanizing`` diction
Authorship of scientific publications is complex especially for research projects with a large number of contributors. ICMJE provides a definition for authors but interpreting the criteria in the real world can prove challenging. Review applicable guidelines to consider when deciding authorship Discuss ethical considerations for authors and sponsors Examine best practices for fair and equitable author selection including strategies to minimize disputes
Trust in health information dissemination is essential. The need to rapidly share non-peer-reviewed content – some of which resulted in retraction - created confusion and mistrust during the pandemic.
- Examine the factors and influences that can taint scientific data and interpretation
- Discuss the ethics of ensuring accuracy and combatting misinformation
- Evaluate scientific communications for quality, rigor, and scientific validity using basic assessment tools
- Examine the main contributors to medical misinformation across social media, predatory publishing, preprints, and elsewhere
Proactively share scientific information with national/regional key accounts/customers and the key opinion leaders within those organizations as well as local thought leaders in both evidence-based medicine and health economics
- Provide communications including formulary presentations, complex medical information/clinical and HEOR data
- Build peer-to-peer relationships with Managed Care Medical/Pharmacy Directors in collaboration with account lead
- Initiate key field based HEOR studies from conception, through protocol development, to execution, completion and dissemination
Preprints have gained popularity as efficient tools for accelerating publishing during the pandemic. While preprints offer several benefits to authors, academic audiences, and the general population, they come with a set of challenges.
- Pinpoint the challenges and opportunities
- Examine the role of preprint in providing speed of access to data
- Discuss the risks to scientific progress and how they can undermine researchers' work
AI can serve as a valuable technology to rapidly provide answers to medical questions and ensure that publication and strategic planning is more accurate and address certain issues such as identifying new peer reviewers, fighting plagiarism and data fabrication. With the publishing system primed for change, how can the industry prepare and put AI to best use?
- Outline the current applications of AI
- Overcome the skepticism of AI integrations in medical writing, communication and publication
- Examine the significant benefits including time and cost-savings in gap analyses and resource-intensive tasks
- Recognize how automated publishing can expedite scientific communication
Social media have become a vehicle for sharing and debating scientific research and replacing the poster halls at congresses. HCPs are increasingly using social media as a valid and trusted platform for sharing opinions, dispelling misinformation, furthering their medical knowledge and engaging with the lay public.
- Discuss how pharma can best engage with discussions on social media to promote accurate interpretation of research and share research updates
- Learn how to overcome compliance hurdles and engage HCPs successfully
- Collaborate with Digital Opinion Leaders (DOLs) to improve the reach and credibility of your messaging on social channels
- Understand how the social media impact of a publication can be
Our facilitated, Virtual Interactive Discussion Groups (VIDGs) optimize peer-to-peer learning by crowdsourcing solutions to common challenges surrounding developing and managing medical publication and scientific communications plans. The connections you make through the VIDGs will become your most valuable takeaways. You will have the opportunity to sit in on one 45-minute sessions with groups capped at 25 to ensure helpful conversations. Choose from ONE of the below: