The following 15 posters will be on display in the Exhibit Hall area at the 2019 Medical Writing & Communication Conference. Poster presenters will be available to discuss their posters on Thursday, November 7, 7:15 – 8:45 AM, and on Friday, November 8, 11:30 AM – 12:30 PM.
M. Denise Daley, MS, MD, FRCPC, ELS, School of Health Professions, University of Texas Medical Branch
Introduction: While reading medical journals, one often sees basic writing errors. This study was conducted to quantify the frequency of grammar, punctuation, and word usage errors in articles published recently in peer-reviewed medical journals.
Methods: After identifying 4 leading anesthesiology journals based on impact factors (Anesthesiology, Anaesthesia,Regional Anesthesia and Pain Medicine, European Journal of Anaesthesiology), the last 3 issues of each journal published in 2018 were retrieved. Anesthesiology is the author’s clinical specialty and was thereby chosen to eliminate misunderstanding scientific content as a potential confounding factor. The Introduction section of every original research or review article in each issue was examined for these predefined errors: due to, singular/plural, if/whether, which/that, and punctuation errors. Other errors were also recorded. Only unambiguous errors were counted.
Results: Of the 142 articles analyzed, 125 (88%) contained at least 1 error. A total of 454 errors were observed, with 0–13 errors per article. The most common errors involved punctuation (318; 70%), primarily misuse or non-use of commas. The remaining errors were as follows: due to, 29; singular/plural, 25; if/whether, 8; which/that, 4; and other, 70. Common other errors included incorrect word usage, missing or extra words, and nonparallel lists. There was no clear relationship between the percentage of articles with errors and the journal or the primary language of the corresponding author’s country (English vs other).
Conclusion: Basic writing errors were identified in almost 90% of analyzed articles from 4 peer-reviewed journals. This percentage is unexpectedly high, especially since only a small portion of each article was evaluated. These results suggest the need for improved writing and editing in medical publications.
Basket Trials for Evaluating Tissue-agnostic Oncology Treatment: Promises and Challenges
Teresa Chu, PhD, and Mary Ellis Bogden; Whitsell Innovations
Tissue-agnostic therapy is a new oncology treatment paradigm based on the genetic profile of the patient rather than the tumor location. In 2018, FDA approved the second tissue-agnostic drug, larotrectinib (Vitrakvi®), for treating tumors that are caused by tropomyosin receptor kinase (TRK) gene fusions, a chromosomal mismatch associated with less than 1% or cancers. Larotrectinib was tested in subjects using a basket trial design. To accommodate the genetics-focused development approach of a targeted therapy, a basket trial utilizes a common genomic screening platform and a master protocol to enroll patients who have a specific genetic profile rather than a particular cancer type. A draft FDA guidance on master protocols for testing multiple cancer subpopulations under a single protocol has been issued in 2018. In this poster presentation, we will discuss the novel design of basket trials, the required innovations, and the associated challenges.
Cleaning House: Reviewing an Updating and In-House Style Guide
Leila Emery, MA; Joyce Hicks; S. Daniel Siepert, MA; Adrianne Loggins, MA; Alyssa Dallas; and Amy Martin, MA; RTI Health Solutions
To outline a process for updating an in-house style guide, including establishing decision-making criteria and implementing changes.
Style Guide Update Process and Application
An in-house style guide increases efficiency and ensures consistency within and among documents. To remain effective, the guide should be reviewed and updated regularly, following an established process.
Convene a small working group of editors, with at least one senior member to provide history and context where needed
Assemble a list of grammar and style questions from editorial colleagues and categorize by topic
Gather real-life examples that exemplify the updates discussed
Review recent AMA updates and consider their application to your organization
Establish decision-making criteria among working group members
Present suggested updates to editorial managers for review and feedback
Compile the final updates and disseminate among your editorial team
Hold training sessions to share changes and answer questions
Review subsequent edits to ensure adherence to updates
Review the style guide yearly to ensure calibration among editors; revise as needed
Conducting regular reviews of an in-house style guide ensures that it remains a valuable and relevant tool for your editorial team.
Covert Leadership: A Backstage Approach to Effective Medical Writing
Katie Bates, PhD, Dwyn DeSilver, BS, and Cathi Harmon, BS; Whitsell Innovations
Mary sits at her desk, a partially finished document on her monitor. Fingers on her keyboard, she hesitates, but not for loss for words. She knows how to write the report, but faces a quandary that affects all medical writers: she is missing reviewer comments, yet is tasked with meeting the timelines. The last conference call was a jumble of opinions bouncing back and forth, and left her with no clear direction. Should she risk disturbing the client and testing their patience? Additionally, the data have been updated - again. In this all-too-familiar scenario, leadership and efficiency are needed, and sometimes the best option is…YOU.
In this poster presentation, we offer solutions to scenarios like Mary’s. We will share experiences from seasoned medical writers, and we will provide real-world ideas on how to lead without authority, exercise diplomacy to your advantage, and provide insight on time management and personal efficiency. After reviewing this poster, your toolbox will be filled with strategies and clear takeaways you can implement into your everyday practices, including being able to identify project-, team-, and time‑management strategies to help grow as a medical writer, and exercise positive and effective influence in medical writing projects.
Current Status on Adverse Event Monitoring and Safety related Label Changes for Statins
Introduction: Around 56% and 39% of population in age groups of 40- 64years and 65 years and above, respectively, fall under cholesterol-lowering treatment eligibility in the USA. Thus with this rising risk of cardiovascular diseases, statin drug use is expanding. Currently there are eight major types of statins being marketed either singly or in combinations with antihypertensive or antihyperlipidemic drugs. Prescribed over long-term basis, possibility of drug-drug interactions and related adverse events is very high. Especially when used in elderly population, long term safety and tolerability is major concern.
Methodology: To gain a better insight into Safety-related Label Changes for Statins, research using existing data was done. PubMed was used to find relevant articles related to the eight statins currently on the market. FDA Data was used to determine if the drug had review priority and/or orphan status. The FDA Drug Safety-related Labeling Changes database was used to look for label changes after January 2016 for the statins. The approved drug label changes, if existed, were noted for each statin. In addition, the FDA Adverse Events Reporting System Public Dashboard was accessed to view demographics, reaction group, and reaction over the past few years. The top five prevalent reactions for all eight statins were noted and used to create graphs displaying the information. The Centers for Disease Control and Prevention database was used to find articles related to the prevalence of cholesterol treatment eligibility and medication use among adults. In addition to this, Eudravigilance and Vigiaccess were searched too for AEs pertaining to the current statin drugs. All of the information accessed and used was relevant as of July 31, 2019.
Results: FDA Adverse Event Reporting System (FAERS) Public Dashboard indicates Rosuvastatin has over 44,000 cases of AEs of which 26,600 are serious including 1,374 deaths . More than 53% of these cases are reported in females, the most common AE being Myalgia. In 2012, some of the major Safety related Label Changes (SrLC) were done for statins. Recently, SrLC related to Rosuvastatin were made under headings of drug interactions (pertaining to cyclosporine and protease inhibitors) and adverse reactions (addition of Interstitial Lung Disease) . Additionally, multiple Fixed Dose Combinations (FDCs) are marketed, exhibiting both strengths and limitations to this approach. The top 5 AEs reported for all the statins were- Musculoskeletal and Connective Tissue Disorders, General Disorders and Administration Site Conditions, Investigations, Nervous System Disorders and lastly Gastrointestinal Disorders. It was also noted that 7 of 8 statins had more than one SrLC.
Conclusion: Majority of SrLCs were related to Drug interactions and AEs, while most common AEs with statins were Musculoskeletal and Connective Tissue related. Continuous monitoring of statin effects either singularly or in combinations, is the best strategy to optimize the health benefits and minimize, if not eliminate, the harm.
Editorial Roadmap: The Path to a Complete, High-Quality Edit
Sinclair Vernon, MA; Margaret Mathes; and Amy Martin, MA; RTI Health Solutions
Objective: To present a roadmap showing the editing steps needed to provide high-quality, consistent documents in an efficient manner.
Editing Process: Format the document according to journal/organizational style or a specific style guide. Develop a project style sheet. Note exceptions to the journal/organizational style and any project-specific terminology. Run spell check to catch misspelled words and grammar errors. Run macros that clean up common errors found in documents. Use consistency-checking software to run a predetermined set of consistency checks. Perform a full edit of the text with attention to style, flow, and grammar. While editing, write down any inconsistencies or issues that would not be caught by a macro or editing software. After editing, use the find/replace function to address these issues. Perform an abbreviation check of the entire document. Perform a reference check or update citations/bibliography if using a reference management software. Run consistency-checking software, spell check, and macros again to catch any errors or inconsistencies introduced during editing. Update hyperlinks.
Conclusions: Following a set editing process ensures high-quality, consistent documents that exceed expectations.
Implementing an Operations Manual to Improve Medical Writing Consistency and Efficiency
Henry Li, PhD; Emerald Feng; Amanda Krzywinski, PSM; and Alex Marcheschi, PharmD; Grifols Therapeutics LLC
Achieving consistency in clinical documents such as clinical study protocols and study reports across different clinical development programs within a company is challenging for several reasons. First, medical writers, both new and established, have diverse backgrounds, creating the need for detailed guidance on medical writing requirements. Second, different reviewers may have different requests for clinical documents, including comments on writing style, which impacts document consistency. Third, standard operating procedures (SOPs) are high level and as such not all encompassing to provide sufficient guidance. Lack of consistency in clinical documents will affect document quality and impede efficiency of document preparation. To overcome these challenges, we have developed a comprehensive Medical Writing Operations Manual. The purpose of this manual is to supplement the SOPs and provide additional, detailed steps for medical writing processes from initial drafting to finalization. Additional considerations for content preparation are also included. This manual is intended to be a one-stop shop for procedures, templates, and style guides that are readily available for medical writers. In addition, this manual is a live document that allows for frequent updates to reflect the changes in procedures, styles, or regulatory requirements. In this poster, we will describe the development and implementation of the Operations Manual.
Increasing Efficiency and Scientific Integrity with Master Trial Charter Documents
Kassel Fotinos-Hoyer1; Janina Wolf, PhD1; Nicholas Enus2; Sayali Karve2; and Andrea Linke2
1Parexel International GmbH 2Parexel International
This poster presents an overview of root-level master documentation as an alternative to template usage in terms of benefits and disadvantages as related to efficiency, consistency, and scientific integrity. A case example involving implementation of a master Charter document across a program of studies, and lessons learned during master document development will illustrate this point.
The Charter is a regulatory document which defines the independent review methodology and assessment criteria. The FDA’s Clinical Trial Imaging Endpoint Process Standards Guidance for Industry (April 2018) defines a Charter as a single document or series of technical documents. Accordingly, we have re-organized our Charter content into a root-level master document to be used in combination with a protocol-specific addendum. The addendum individually details protocol-specific information relevant to the independent review including rationalized modifications from the standard approach.
Preliminary data show a reduction in the average number of drafts required to finalize Charter v1.0 from 2.2 to 1.8 and consequently, a reduction in the average number of days required to finalize Charter v1.0 from 102 to 48. Extension of the root-level documentation concept to other documents is being piloted and is expected to result in comparable advantages feasible (e.g., image acquisition guidelines for investigator sites).
The Informed Consent Document: New Federally Required Elements
Linda Rowse, Medical Writer and Consultant, Whitsell Innovations
Documentation of a subject’s (or their legally authorized representative’s) voluntary agreement to participate in clinical research is one of the United States (US) Federal requirements for Institutional Review Board (IRB) approval of clinical research. The informed consent form (ICF), (paper or electronic), is used for documenting informed consent and must contain required elements in order to obtain IRB approval. On 21 January 2019, the revised Federal Policy for the Protection of Human Subjects (2018 Revised Common Rule) became effective, resulting in the requirement to present 5 key pieces of study information at the beginning of the ICF and the addition of 4 new ICF elements. The Food and Drug Administration has yet to harmonize their regulations but considers the “new informed consent requirements” to be “not inconsistent with FDA’s current policies and guidances.” This poster provides the 5 key pieces of study information and the 4 new ICF elements with the corresponding regulatory language from the US Federal Register.
Mastermind Group Case Study for Mid-Career Freelancers: Insights and Takeaways
Mia DeFino, MS, ELS, DeFino Consulting, LLC; Kristin Harper, PhD, MPH, ELS, Harper Health & Science Communications, LLC; Karoun H. Bagamian, PhD, Bagamian Scientific Consulting, LLC; Dana Barberio, MSc, Edge Bioscience Communications; Jessica Yen, MS, JHY Communications; and Donna Simcoe, MS, MS, MBA, CMPP, Simcoe Consultants, Inc.
What is a Mastermind group? It’s a group of like-minded individuals that meets regularly by phone or in person with the objective of helping each member meet their goals. We are sharing information from our Mastermind group, which has been meeting for the past year, in hopes that it may help others interested in forming their own Mastermind groups. Our group consisted of six freelancers with 3 to 6 years of freelancing experience who committed to monthly conference calls for a year. By meeting regularly, we hoped to share new opportunities and valuable information on what was working for developing our businesses, broaden our network of trusted freelance colleagues, and keep one another accountable toward making regular progress toward our business goals. We were convinced that a supportive forum would help all of our businesses grow. In our initial meeting, we determined the group needs were fostering commitment to setting and trying to achieve goals, encouraging respect and resourcefulness to help others in similar situations, paying attention to market trends, and sharing personal insights to help others in the group. To meet these needs, we settled on a meeting structure in which members would start by briefly updating the group on their progress since the last call. Then, a single member would lead a longer discussion about a problem they were having, a goal they would like to achieve, or a business-related topic for discussion. Prior to each meeting, the person leading the meeting would send an agenda to all members, to give members time to think about the issues at hand. Here, we present themes and insights that arose from our first year of meetings, including the practices that worked best, those that needed to be changed, and the tangible benefits of participating in the group.
Overview of Lay Summaries: Current Use and Writing Guidelines
Beth Knight, PhD; Whitsell Innovations
In many areas of scientific and clinical research, demand is rising for improved communication, transparency, and patient centricity. Much of the public is unable to understand clinical trial registries, scientific and clinical research proposals, results, and publications. This poster will present how the lay summary addresses this problem by providing accessible, engaging, and easy-to-understand language for patients and the public. Lay summaries are increasingly recommended or required for clinical trial registries, grant applications, journal articles, ethics committees (Institutional Review Board, Institutional Animal Care and Use Committee), journalism, outreach, and patients’ organizations. This poster will review current lay summary usage, with a focus on the European Union Clinical Trial Regulation (EU CTR) No 536/2014 mandate for lay summary inclusion with all clinical trial registry submissions, effective 2020. Guidelines for translating complex research into a lay summary will be shared, with tips and tricks for language, readability, formatting, style, numbers, and visuals. Lastly, technical tools to help the writer evaluate their lay summary drafts will be shared.
Recent Trends in Data Sharing Statement Requirements Among Medical Journals
Micah Robinson, PhD; Jon Nilsen, PhD, CMPP; Tim Peoples, MA, ELS; Jacqueline Sayyah, PhD; and Dikran Toroser, PhD, CMPP; Amgen Inc.
Background: The ICMJE issued an updated policy requiring inclusion of data sharing statements in manuscripts submitted to ICMJE journals after 1 July 2018. We surveyed leading journals to determine the effect of this policy change on their submission requirements.
Methods: We analyzed instructions for authors and submission websites for 16 general or specialty peer-reviewed medical journals (impact factors ranging from 6.314 to 79.258) in February and September 2018, before and after the ICMJE policy change, respectively. We also recorded whether the data sharing statement, if required, was to be included in the manuscript text or on the submission portal.
Results: Before the new policy, 8 of 16 (50%) journals required a data sharing statement; following the policy change, this increased to 12 (75%) journals. Journals with a data availability–related question in the submission portal increased from 2 to 6 after the policy update. Although each journal that required a data sharing statement met the ICMJE policy, the specifications for placement of the statement in the manuscript and instructions on how to draft the statement differed for each journal.
Conclusion: We observed an increase in journals requiring data sharing statements after the ICMJE required such statements, with considerable variation in journal guidelines. Standardization of the reporting instructions across journals may ease the adoption of the policy.
Similarities and Differences Between Nonclinical and Medical Writing
Rachelle Baker, ELS, and Lisa Poppenberg, MPH, ELS; Takeda Pharmaceuticals, Inc.
Nonclinical (preclinical) writing support in regulatory submissions is often regarded as fully removed from clinical writing. However, we contend that the structure and processes for medical (clinical) writing is analogous to that of nonclinical writing. As is typical for medical writing resourcing, nonclinical writers are typically embedded within a pharmaceutical organization, brought in as contract writers, and/or obtained via freelance or consultancy. However, Nonclinical Writing as a function is generally housed distinct from Medical Writing. We compare and contrast the general structure of nonclinical and medical writing groups, the scientific competency skill-set, and the primary CTD modules supported by each. Additionally, the standard nonclinical study design and data reporting process is presented and compared to that of Clinical Protocols and CSRs. Nonclinical writing is increasingly becoming an ongoing critical need for large organizations and an acute critical need for smaller organizations seeking IND/CTA filing support, necessitating effective forms of communication and cross-collaboration between nonclinical and clinical writers. We present a framework to enable these efforts here.
A Step in the Write Direction: A Career Move from Research to Medical Writing
Irene Papanayotou, PhD; Catherine Roy, PhD; William Buchta, PhD; and Cody Nichols, PhD; Whitsell Innovations
Medical writing encompasses an extensive range of topics, tasks, and teams, allowing for contributions from professionals with varying backgrounds. We will consider the shift from a research career to the world of medical writing - a transition which can benefit from two main approaches: 1) recognizing and capitalizing on strengths obtained from research experiences, and 2) identifying available resources to develop and improve medical writing-specific skills.
Research backgrounds contribute assets to medical writing, including the skills of data interpretation/observation, communication of research, and project management. The learned method of approaching and answering research questions can factor into the scientific foundation of medical writing, while the overall management of research adds to the medical communication structure.
Several resources within a medical writing group can facilitate learning and refinement of medical communication skills for those seeking to transition from a research-based career. These include an extensive mentoring system with experienced writers, a document teaching library for exposure to the breadth of materials, and professional development opportunities to strengthen writing abilities.
While the transition from a research career to medical writing may seem daunting, a research background partnered with available resources allows for a unique opportunity to acquire and strengthen the necessary medical writing skills to succeed.
A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form: Where Do We Go from Here?
1 Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute 2 Office of Clinical Research Policy and Regulatory Operations, Division of Clinical Research, National Institute of Allergy and Infectious Diseases 3 Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases
Background: The 2018 Final Rule updated requirements for writing informed consent forms (ICFs), including the addition of a “Key Information” section to present information that will most likely help someone decide whether to join a study, such as the “most important risks.”
Methods: We asked colleagues what risks should be considered Key Information. We surveyed 3 cohorts involved in human subjects research at NIAID: IRB members, medical monitors, and principal investigators (N: 29). The survey presented an ICF Potential Risks section from an IRB-approved study, and respondents indicated which risks they considered Key Information.
Results: We received 9 responses (response rate: 31%). Of 37 risks, all but 2 were chosen as Key Information by at least 1 respondent (mean risks selected: 12; range: 6-19). Only 7 risks were chosen by at least half of respondents; all were risks of the study agent. The most frequently chosen risks were the study agent’s most common side effects (8 respondents). Seven respondents included a statement that there could be other risks of the study agent that are not yet known. The general side effects of drugs in the study agent’s class (monoclonal antibodies) were chosen by 80% of IRB members but no other respondents.
Discussion: Our results highlight variability in viewpoints of research professionals on selecting risks as Key Information. As medical writers, we have used the limited consensuses shown in this survey to develop Key Information.