Abstracts for Poster Presentation
P1 - Cross-Cultural Communication Training: A “Passport” to Your Team’s Success
Cindy Fernández, MSD
Takaaki Ishine, MSD KK
Jennifer Clemens, Merck
Merck/MSD’s Medical Writing department recently expanded globally. We viewed this growth as an opportunity to enrich our communication styles and create an environment where everyone’s voices are heard.
Did You Know?
- Fostering diversity is a competitive advantage.
- Understanding cross-cultural communication is a key element for success and enhances effective teamwork.
Methods: Our Virtual Trip Around the World
Fourteen Medical Writing colleagues representing the US, Colombia, China, and Japan participated in an initiative that consisted of:
- A fun “icebreaker” kick-off meeting. We shared photos, backgrounds, and created team names.
- Monthly discussions and reading assignments to understand differences/similarities in communication and working styles.
- Department-wide presentations accommodating different time zones.
Results: It's a Small World After All
- Colleagues learned from each other, experienced other cultures, and shared knowledge with the department.
- We learned that openness, flexibility, and curiosity are key.
Conclusions: Take-Home Messages
- Be Clear: Do not assume that everyone understands you or your communication style.
o US colleagues often write brief emails without friendly greetings, which can be perceived as angry or offensive.
o Non-US colleagues should not be afraid to ask questions/express opinions.
- Be Understanding of Preferred Communication Methods: Ask everyone for input in writing and verbally.
- Be Willing To Learn: Show a genuine interest in your teammates.
We Now Have:
- A stronger team with solid connections.
- A foundation for future global initiatives.
- An appreciation of “softer” skills of cross-cultural communication to build a truly successful team.
P2 - Use of Google Analytics to Evaluate How EMWA Members Use the EMWA Conference Mini-Site
Diarmuid De Faoite, Smith & Nephew, Clinical Scientific and Medical Affairs, Global Clinical Strategy
The EMWA conference mini-site was introduced for the spring 2017 conference (Birmingham), and has been used for three further conferences. Utilising the same mobile responsive platform as the EMWA website, the mini-site replaces the previous conference app. Only anecdotal evidence previously existed to gauge how useful the mini-site is to EMWA members
Google Analytics was used to analyse mini-site user engagement statistics from February 1, 2017 to November 30, 2018. The following metrics were examined: number of users / sessions, average time per session, the number of pages visited per session and the most popular pages. Users’ location and type of device were also evaluated.
For four conferences over two years, 9,374 visitors to the EMWA conference mini-site engaged in 24,252 sessions for a total of 78,266 page views. Visitors to the mini-site averaged 4:35 minutes per visit, viewing approximately three pages in this time.
Pages with the highest number of visitors (descending order):
2. Fees and registration
4. Symposium programme
5. “At a glance”
The highest amount of page views on a single day was 1,937 (20 Feb 2018). Three of the four actual conference venues were in the top ten users’ locations, indicating use during the conference. 77% of users used a PC, 18% a mobile phone, and 5% a tablet to access the mini-site.
Visitors to the mini-site seek information in advance and during EMWA conferences. Website statistics suggest the EMWA conference mini-site has gained wide acceptance among members.
P3 - Authoring for the Real World: Unique Challenges and Solutions
Shruti MP, Anand Devasthanam, Angela Vinken, PAREXEL International
Abstract body English language (UK spelling) Maximum 250 words Pharmaceutical companies and regulatory agencies utilise RWE reports to improve patient care (by optimising treatment approaches and guidelines) and support decision making. Incorporating forward thinking into anticipated outcomes and identifying target audiences early on is imperative as part of design and operational delivery. For example, a PASS report requires a different authoring approach than a disease registry to understand current treatment patterns better.
The RWE environment allows treatment and publication strategies to be reviewed regularly and adapted accordingly. However, there are several challenges in authoring a compelling RWE document. Strategic challenges include having experienced writers and reviewers who understand the need to know their audience first, as the audience dictates the structure and content of a RWE document. Other strategic bottlenecks are adjusting to operational limitations and working with multiple stakeholders unaware of RWE requirements; this leads to a lack of constructive feedback and inefficient discussions.
Tactical pain points include uniqueness of study types and designs, resulting biases, limited sample and guidance documents, and working with presumptions that RWE studies are straight forward, easy to report and ‘must’ have a quick turnaround.
Limitations in knowledge and expertise in the industry necessitate heavy reliance on experts to drive these studies.
Adopting a flexible mindset to tackle these challenges entails building a core group of experts, enhancing knowledge of regulatory guidance, breaking free from a template’s limitations on a case-by-case basis, and remaining flexible. Doing so will help authors create fit for purpose reports with superior readability and comprehension.
P4 - In Which Fields of Medicine are Predatory Journals Most Common?
John Watson, Amir Kamali, Diarmuid De Faoite, Smith & Nephew, Clinical Scientific Affairs, Global Clinical Strategy.
In 2011, the U.S. librarian and academic Jeffrey Beall defined predatory journals and publishers as those “that unprofessionally abuse the author-pays publishing model for their own profit.” The current study was undertaken to ascertain how widespread predatory journals are in different fields of medicine.
A review of the journals listed at https://beallslist.weebly.com/standalone-journals.html was undertaken in December 2018. This is an archived version of the original Beall's list available until January 2017, with new predatory publishers added to the original list since then. A hand search was conducted to identify journals offering articles on medical topics. Links that were inactive or flagged by security software, non-English journals, or content with no current or probable clinical applicability were deemed ineligible. Journal selection was made by a medical writer, with the results checked by other team members.
Of 1,403 journals listed, 379 featured publications on topics related to clinical medicine. The majority (206; 54.4%) offered general medical articles alongside unrelated fields (eg, geology, literature). This was followed by journals concentrating on pharmaceutical research (115; 30.3%) and complementary/alternative medicine (16; 4.2%). Of journals devoted to specific fields of medicine, only ENT/dentistry (7; 1.8%) and oncology (6; 1.6%) accounted for >1%.
Over 25% of journals identified as predatory feature articles on medical topics. However, such journals are defined by a lack of specificity, and commonly group medical articles together with those on unrelated academic fields. The largest concentration of medical-specific journals feature articles on the development and research of pharmaceuticals.
P5 - Essential elements for a successful career transition in Medical Writing: A case report and post post-doctoral professional follow-upSaannya Sequeira, ClinSearch, Malakoff, France
There is frequent discussion about professional development and changes in career pathways. However, while many speakers and authors advocate their particular point of view, there is a paucity of information that relates to the essential elements for a successful, smooth change of career direction.
Following the completion of a doctorate in structural biology and a brief post-doc, I relocated from the UK to Paris. I then proceeded to learn French and pursued a postgraduate diploma in clinical research (DIU Formation des Investigateurs aux Essais Cliniques des médicaments), as part of which I did an internship as a medical writer, and was eventually employed by the same company.
In addition to the knowledge gained from the PG diploma, I have found that the key elements in a successful transition are 1) mentoring and 2) team support. My internship project was a systematic review of the medico-economic outcomes of the remote monitoring of implantable cardiac defibrillators; this has been submitted for publication and I am the lead author. There are several tools that make writing a systematic review easier, and the mentor and the team are essential to discovering these tools and effectively implementing them.
While earning a PhD provides the basic research skillset, the transition to clinical research and a CRO is vastly different from benchtop work. In this regard, the quality of your mentor and colleagues are crucial in quickly developing the skills necessary to succeed in clinical research in the private sector.
P6 - Narrative writing is more than writing: Development and implementation of a VBA macro-based tool to assist the Narrative Writing Process.
Carolina Salazar Lara, MSD
The process of narrative writing, while constantly struggling to meet tight regulatory deadlines, is challenging and time consuming for the writer who needs to manually access and include the information from the clinical data. This additional step needed to find the subject’s relevant data among multiple files, may result in errors, lack of consistency on which data are being reported; and additional resources needed to meet milestones, particularly for projects requiring many narratives.
We developed a macro-based tool using Excel VBA that assists the narrative writing process by providing a semi automated and easy-to-use approach to visualize the SDTM clinical data. This tool assists the project lead to prepare the data for the Narrative Medical Writers (MWs) and Clinical Technical editors (CTEs) by: consolidating data from multiple files into a single Excel workbook; allowing for the definition of relevant variables within each data domain and its subsequent display (hide - unhide); implementing the option to filter all the data by a subject; and integrating main and supplemental data sets into a single view.
This tool enhances smarter data visualization by providing an easy approach to access and interpret the relevant data for a subject; without modifying the data source, and being flexible to consider on-as-needed requirements for each therapeutic area and project.
This tool has been tested by NMWs and CTEs in multiple Oncology and Infectious Disease projects, for different indications, at MSD. It has positively impacted data visualization; increasing the effectiveness and efficiency of narrative authoring and QC.
P7 - Basic Prerequisites to Enter into Medical Writing Profession - A Retrospective Indian Study
Ali Nasir Siddiqui, Gunjan Agarwal, GCE Solutions
Medical writing is commonly an outsourced clinical activity in India. The present study aims to assess the academic credentials of candidates who chose medical writing at any point of their career. Additionally, to estimate the duration (in years) to get into medical writing profession, if a candidate picks another domain as first job.
In this retrospective study, resumes of medical writers who applied in GCE Solutions Inc (contract research organization) through Talent Acquisition Cloud-based platform (Taleo) from November 2017 to December 2018 were included. The demographic details, latest academic credentials, and number of years spent in each job were investigated.
A total of 210 resumes were uploaded, of which 167 met the inclusion criteria. The mean±SD age of candidates at entry was 27.74±4.99 years. Equal proportion of males and females applied for jobs (79[47.3%] and 80[47.9%], respectively). Of 167 candidates, 97(58.08%) had their last qualification as postgraduation followed by doctorate (PhD) (53[31.73%]) and bachelor (12[7.18%]) degrees. Pharmacy (postgraduates: 43[56.58%]; PhD: 27[35.52%]; bachelors: 6[7.90%]) topped the list of specialization. Less than 15% of candidates began their career with medical writing profession (regulatory: 20[11.97%]; publications: 10[5.99%]) while remaining opted for other jobs and spent 3.64±3.84 years before shifting into medical writing domain. On an average, a candidate spends 2.13±0.42 years in one job followed by shift into another job.
Majority of medical writers are either postgraduates or PhD holders in pharmacy or life sciences. Awareness of medical writing among fresh pass-outs is low, which can be enhanced by attending workshops and conferences.
P8 - Developing an efficient Quality Control (QC) process for compressed document timelines
Anja Angele, Corinna Kloeble, Dr Thomas Schindler, Boehringer Ingelheim Pharma GmbH & Co. KG
Quality Control (QC) is an important part for developing high quality documents. It ensures correctness and consistency of data and descriptive information. Industry is constantly struggling to shorten the time between data base lock of the last trial and submission. As a result, less and less time is allocated to the writing and QC of documents. We started developing QC methods suitable for compressed timelines.
As a first step, we collected and analysed the QC findings in 6 recent time critical CSRs. The individual QC findings were categorised and ordered according to their frequency. The resulting list contained 23 groupings representing different types of QC findings, e.g. wrong numbers, incomplete statements, format issues. The different groupings were randomly ordered into a list. This list was then sent to medical writers (n=22) and medical writing coordinators (n=7) with the request to assign them into either major, moderate, or minor category. “Major” was to represent a group of findings that needed to be corrected in any case, “moderate” signified QC findings that should be corrected but could be left unchanged in extremely time-critical CSRs, and “minor” was defined as QC findings that could be left unchanged.
Results & Conclusions
Of the 23 groupings, 13 were classified as “major”, 8 as “moderate” and 2 as “minor”. In conclusion, 10 categories of QC findings could potentially be left unchanged in extremely time-critical situations. By introducing a hierarchy of QC findings, medical writers were given the opportunity to focus on those findings that represent the most critical QC findings.