The 17th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) was held virtually on 12–14 April 2021. The event attracted a record-breaking number of participants with over 650 attendees. The theme of this year’s meeting was ‘Medical communications 2.0: Creating and embracing opportunities in a time of transformation’.
A summary of the third day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.
Keynote: patient partnership in medical conferences
For his keynote lecture, Audun Utengen (Symplur) gave an overview of patient participation at healthcare conferences and presented some of his research into the benefits of their involvement.
The expression “nothing about us without us” has been embraced by patients seeking more involvement in the healthcare process.
The expression “nothing about us without us” has been embraced by patients seeking more involvement in the healthcare process and with their help, doctors can go from knowing how to treat a disease to learning what it is like to live with the disease. Utengen’s research has shown that healthcare conferences with engaged patients can boast:
- increased involvement with the public
- dissemination of information to a wider network
- increased speed of information flow.
Benefits can also be seen beyond the conference network. There is the potential for a positive financial impact if patients are involved early in the process, such as in the design and conduct of clinical programs, an important factor for sponsors who can be reluctant to consider patient engagement. Utengen went on to share three findings from social media and real-world data during the current pandemic:
- increased engagement between patients and doctors on Twitter, which seems to be going beyond COVID-related conversations
- increased sharing of medical information by doctors resulting in greater access for the public
- increased Telehealth visits between doctors who are regular Twitter users and their patients.
Finally, Utengen outlined two frameworks aimed at getting patients involved. The Patients IncludedTM conference charter demonstrates that a conference organiser is committed to ensuring patients are included and not exploited. Everyone IncludedTM is “based on principles of mutual respect and inclusivity” to drive “healthcare innovation, implementation and transformation” and as of April 2021 over 1,400 conferences have signed the Everyone IncludedTM declaration representing over 55 countries.
When social distancing meets social networking: how societies are embracing the new digital world
Clarinda Cerejo (Cactus Life Sciences) opened a panel discussion between representatives from three academic societies, Angela Cochran (American Society of Clinical Oncology [ASCO]), Jennifer Regala (American Urological Association [AUA]) and Alex Zapple (American Society of Nephrology [ASN]), to gain their insights on implementing and running virtual conferences.
Medical conferences have been run the same way for decades, so the impact of COVID and the sudden move to a digital format created huge logistical challenges that had to be met head-on while trying to negotiate and climb a very steep learning curve. Overall benefits included improved accessibility, more international attendees and content being available for longer periods of time; challenges such as Zoom fatigue, diminished interactivity and catering for different time zones were also apparent.
It was difficult to recreate the collaborative atmosphere that would normally exist in a poster hall and new ideas are needed to increase the traffic and interactions with ePosters.
Zapple described some of the initiatives the ASN used to try and enhance attendee engagement, such as virtual city tours, wellness activities and scavenger hunts to encourage wider exploration of the platform. All of the panellists agreed that society newsletters could be better utilised to connect members and act as a cross-pollination resource. How best to use social media for future meetings is unclear but other platforms, for example TikTok for younger members, need to be included. Some medical conferences have also created opportunities for patient participation or are planning to do so. Zapple noted the inclusion of a patient on the planning committee and the free registration offered to patients to attend the conference.
So, what does the future hold for medical conferences? Live meetings will resume, but everyone accepted that hybrid meetings are here to stay, at least in the short-term, and it will be critical to ensure an inclusive and balanced experience for both live attendees and the virtual audience.
Hybrid meetings are here to stay, at least in the short-term, and it will be critical to ensure an inclusive and balanced experience for both live attendees and the virtual audience.
Authorship challenges & solutions: update on the Authorship Algorithm
Carolyn Hustad (Merck & Co., Inc.) introduced the session by providing a background to the ISMPP Authorship Taskforce. Hustad explained that the Taskforce was set up to address the challenges publication professionals may face applying the International Committee of Medical Journal Editors (ICMJE) criterion 1 as the basis of author selection, and to provide clarity and recommendations for the author selection process.
What does the Authorship Algorithm do?
Avishek Pal (Novartis) gave an overview of the development of the Authorship Algorithm and explained how the tool will work. Primarily, the Algorithm aims to define and rank relative substantial contributions to a study or project with a large number of contributors. Secondly, it aims to define the author sequence in the by-line and identify first and senior author positions.
How does the Authorship Algorithm tool work?
The user assigns scores (on a scale of 0–5) for each contributor across multiple subtopics within the following categories:
- study concept or design
- acquisition of data
- data analysis
- data interpretation.
A weighted scheme allows prioritisation of the categories for flexibility and the algorithm generates a total score based on the score for each contributor and the weighting scale assigned. Pal noted that there is no benchmark score to define which contributors should be selected as authors; the tool should be used as a guide for users to narrow down a list of candidate authors based on their relative contributions.
When will the tool be available?
The tool will shortly be starting a closed pilot testing phase and following this the Taskforce are hoping to rollout the Authorship Algorithm in Q3 of 2021 – watch this space for updates!
What is next for the FDA and what will it mean?
Jon Bigelow (Coalition for Healthcare Communication) reviewed the recent challenges faced by the US Food and Drug Administration (FDA) and its priorities for the future.
2020: a productive but testing year
The FDA plays a crucial frontline role in public health crises and helps drive pharmaceutical research and development, medical communications and marketing. Bigelow explained that after the strong and dynamic leadership seen during 2009–2019, 2020 was a testing year both scientifically and politically for the FDA.
The first hurdle was a controversial Commissioner appointment with Stephen Hahn in 2019, whose lack of prior experience impacted the response time to the COVID-19 pandemic, leading to unprecedented political criticism. This was followed by a series of errors during the pandemic, including delays in testing kit approvals and the mistaken emergency use authorisation (EUA) for hydroxychloroquine despite a lack of evidence. These events seriously impacted the FDA’s credibility and public trust and helped feed misinformation on the pandemic. They also contributed to the anti-vaccination movement in the USA – Bigelow quoted a study that found 30% of the population are still reluctant to get vaccinated against COVID-19.
2020 was also a year of accomplishments with record approval times, for example the Pfizer vaccine was approved in just 3 weeks versus the usual 1-year timeframe. A new Commissioner will be appointed this year, marking a fresh start for the FDA. Bigelow outlined the 4 key challenges they face moving forward:
- Drug approvals. There is a backlog of approvals to process, plus next steps for COVID EUAs given in 2020.
- Modernising clinical trials. There are several initiatives to change trial design requirements for pharmaceutical companies (including improving the diversity of trial populations), and also internal reorganising to handle the input. There have also been disruptions to many non-COVID trials.
- Facilities inspections backlog. As a result of the pandemic and the volume of overseas production, there are over a thousand uninspected facilities, which pose a high risk to public health and cause drug approval delays and calls for drug importation.
- Operations and strategy. There are ongoing challenges with budget, recruitment and internal processes, including the PDUFA 7 (prescription drug user fee program), which sets user fees and focuses negotiations between the FDA, industry and congress.
Bigelow summarised that the main learning for the FDA from the COVID-19 pandemic is that strong leadership and effective communication skills are crucial in the age of social media.
ISMPP leadership update
In his Leadership Update, Robert Matheis (ISMPP President and CEO) explained how the COVID pandemic has thrust medical communications into the spotlight and transformed the “importance of our profession”. Suddenly everyone is an expert in scientific research and clinical trials, is questioning data reliability and has an avid desire for new information thereby increasing the demand on publication professionals to deliver on all fronts.
The entire industry has had to evolve rapidly but has also been given an “opportunity to shine”.
We are at the front and centre of medical communications ensuring that the data are reliable and accessible. The future will include, among other things, pressure to publish faster, more open access, increased digital content and greater patient involvement. Matheis encouraged us to be proud of our profession and concluded with this commitment “ISMPP remains your ‘go to’ professional society for medical publishing and communications”.
Best practices in virtual speaker management
The move to virtual congresses during the COVID-19 pandemic has presented a key challenge – how to keep audiences engaged remotely and with record numbers of attendees at virtual events, this challenge is likely to continue. Using language from the theatre, Richard Davis (Molecular Cancer Therapeutics, AACR) and Maggie Landis (Ashfield) discussed key considerations for successful virtual presentations.
Set the stage
Although content is crucial, the impact of a presentation can be lost if the filming set up is not optimised. The goal is to have direct sound using headphones or a microphone, strong front lighting and a clean background free of distractions. Framing can help the presenter feel as though they are having a conversation with the audience or fellow panel members – this will ensure a more natural presentation. Key tips include:
- Position the video of panellists near the camera to simulate a face-to-face conversation.
- Alter the screen height so the camera is at eye level.
- Place the script or any notes behind the camera or close to it on the screen.
Preparing the actor
Practice makes perfect, and this applies to virtual presentations – even those that are pre-recorded where there is the opportunity to do several takes. A rehearsal allows time to test the equipment, run through the presentation and make sure the speaker is comfortable ahead of the recording or live event. Landis emphasised the importance of having not just a Plan B, but a Plan C as well, to account for any unforeseen problems.
Davis also ran through useful breathing techniques and exercises to help the speaker overcome any vocal issues and reminded the audience of the importance of posture and breath control for clear diction.
Playing the part
Once the filming set up is optimised and the speaker is prepared, the final step is effective delivery of the presentation. Davis showed how three stage concepts can be applied to scientific congress presentations to keep the audience engaged:
- Partnering – direct your dialogue at a partner, in this case the audience or panel member.
- Illusion of the first time – although the speaker has (hopefully) rehearsed, aim to make the content appear fresh and new to the speaker.
- Getting to your task – think about the goal of the presentation, what obstacles may prevent this from being achieved and the tactics that can be used to overcome them.
The digital therapeutics revolution: are medical communications professionals prepared?
While still relatively novel, the use of Prescription Digital Therapeutics (PDTs) is increasing. In this session, Randall Kaye (Neurana Pharmaceuticals) and Samuel Falsetti (MEDiSTRAVA) tackled the key challenges when developing and executing medical communications for PDTs.
Software applications that treat a disease or condition, PDTs may be prescribed as a stand-alone treatment, alongside or in combination with a drug therapy. It was emphasised that while the modality may use the strengths of mobile software to deliver treatment, it does not fall under the category of a generic ‘app’. PDTs should adhere to Industry Core Principles, including validation through rigorous randomised controlled trials and undergoing regulatory clearance or approval.
When considering the question ‘when is the best time to initiate medical affairs activities?’ in relation to PDTs, Kaye and Falsetti responded with a unanimous “now!” The following key points were highlighted:
- Help patients and prescribers understand not just the safety and efficacy of the therapy, but why it is valuable to them; this requires careful planning.
- PDTs are a powerful data collection tool, but how to tailor data collection and outputs is a challenge that requires proactive thought in the early stages of development; be open to exploratory outcomes, which can in turn shape the next phase of data collection and analysis.
- Be aware that the developer can continuously generate and apply real world evidence to improve the PDT and expand labelling claims.
- Publications are a huge educational opportunity; it is crucial not to assume that your audience automatically understand the modality – PDTs are a new concept, and as such not frequently communicated in the literature.
- Consider how to introduce a new modality and accompanying lexicon to those that may not yet understand the product specifics.
- Decide who to communicate to and when; digital journals are useful for communicating to digital opinion leaders and publishing data specific to digital modalities, while general medical journals are more appropriate for reaching the healthcare professionals and patients that will be utilising the therapy.
- Communications will need to reach beyond the specialist; a range of healthcare professionals may be responsible for understanding and advocating a PDT in a particular therapy area.
- An intrinsic worry for healthcare professionals is that the PDT will replace them; it is key to convey that PDTs have the ability to improve patient care and supplement existing roles rather than replace them.
PDTs: the focus is on outcome enhancement and improvement.
It was confirmed that providers, regulators, and payers will inevitably be forced to reassess approaches for inclusion of PDTs in treatment strategies across multiple therapy areas. Work has already begun to ‘broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics into healthcare’ through collaborative educational networks.
Metrics matter: determining the success of your scientific communication platform
Scientific communication platforms (SCPs) are widely used within the pharmaceutical industry to provide a strategic scientific foundation for the medical communication plan of a product and all subsequent initiatives. However, it is critical that engagement and use are considered during the development of the SCP to ensure that it reaches its full potential, and that the success of the SCP is measured following roll out. In this session, moderated by Boyd Scott (Merck & Co, Inc), panellists Keith Gaddie (Vertex Pharmaceuticals), Gretchen Chidester (Biogen) and Jamie Kistler (Parexel International) explored the use of metrics to determine the success of SCPs.
A metric is a quantifiable measure used to assess success.
Gaddie began the session by focussing on the barriers and challenges that may exist when implementing metrics to measure SCP success. To understand the current situation regarding the use of metrics, a survey was shared via ISMPP LinkedIn and ISMPP Connect with industry professionals who have the experience of developing or assisting with SCPs. Results from the survey revealed that the use of metrics to assess success is currently limited. Exploring the reasons for this, Gaddie noted that perceived barriers and challenges to the development and implementation of metrics may include those related to the organisation structure of the pharmaceutical company – for example, the SCP may be owned / developed by a simple Publications Group or a broad Medical Communications Division (encompassing teams related to Publications, Medical Information and Congress activity), which can impact implementation. In addition, logistics around internal training and rollout uptake, as well as budget and timing, can constrain both the implementation of the SCP and how success of the SCP is measured.
Moving on to discuss internally focussed metrics, Chidester returned to the results of the survey – while the use of internal metrics to track success of SCPs was limited among the respondents, several noted that they use a web-based platform (for example, SharePoint), which can facilitate the tracking of visits to the SCP. Examples of qualitative measures used by respondents for tracking SCPs include surveys, internal discussions (1:1 or small groups), or periodic review of documents. Chidester noted that the identification of appropriate internally focussed metrics requires careful consideration of key questions:
- What do you want to understand?
- Example: are internal stakeholders actively engaging with a web-based SCP?
- How will the information obtained be actionable?
- Example: low engagement may indicate a lack of awareness (action: re-communicate where the SCP can be found) or a need for an update (action: evaluate relevance of current content).
- What information is available to help answer the question? How and when will you collect this information?
- Example: visits to the SCP (assess immediately after roll out and at prespecified points thereafter – for example, 1 month, 3 months, 6 months, 1 year).
The ISMPP survey also explored externally focussed metrics, the results of which were presented by Kistler. Again, the respondents had limited experience of external metrics – although several respondents cited the use of literature tracking and manual analysis to report on language / lexicon utilisation. In the future, there is likely to be more focus on novel assessments to gauge external success of SCPs, utilising artificial intelligence and web listening platforms. To that end, Kistler provided an overview of a ‘web listening’ pilot study that will evaluate SCP success by exploring stakeholder sentiment and understanding of key communication themes and language adoption versus baseline. Utilising multiple online sources – including online news, healthcare forums, social media outlets, patient message boards, blogs and YouTube – the project goals include an analysis of:
- the stakeholders who are discussing the data (including what is being said and the sentiment)
- gaps in understanding
- whether the communications align with the lexicon
- how communications change over time
- how communications change after key publications.
Kistler hopes to share the outcomes of the pilot study in the future.
Balancing priorities and safeguarding mental health
Around 1 in 4 people will suffer from a mental health illness at least once in their lives and the lost productivity as a result of anxiety and depression is estimated to cost the global economy US $1 trillion each year. Yet mental health issues are often still stigmatised and considered a ‘taboo’ topic. Prit Moran (Nucleus Global) and Brendan Murphy (Scientific Pathways, a subsidiary of Nucleus Global), both Mental Health First Aiders, explained why it’s so important to manage mental health, described Nucleus Global’s mental wellbeing initiative and shared helpful tips for maintaining mental wellbeing in the workplace.
Why has mental wellbeing become a priority now?
The culmination of several factors means that mental wellbeing in the workplace has become a priority at this time:
- five generations working side by side for the first time (as a result of people living longer and retiring later)
- the ‘always on’ culture facilitated by technology
- the COVID-19 pandemic, which has led to a potential global mental health crisis as a result of social isolation, anxiety and people being unable to access mental health care.
The cost of not managing mental health and wellbeing in the workplace
The implications of ignoring employee mental health are considerable.
The implications of ignoring employee mental health are considerable, including reduced productivity, higher staff turnover and consequently higher recruitment costs, a bad company culture and a tarnished company brand.
Creating a positive health and wellbeing culture
Moran described the initiatives that Nucleus Global have instigated with the aim of creating a positive health and wellbeing culture including:
- training of 28 Mental Health First Aiders
- provision of a Global Employee Assistance Programme
- introduction of ‘Breakfast Breakout’ sessions facilitated by Mental Health First Aiders to encourage connection with people beyond day-to-day work interactions
- provision of wellbeing resources on the company intranet
- sending care packages to employees during the COVID-19 pandemic
- setting up a Mental Health Resource Group (a forum for guidance/help)
- scheduling of wellbeing activities and seminars throughout the year.
The role of the Mental Health First Aider
Murphy described the Mental Health First Aid (MHFA) qualification in more detail. Training is provided by MHFA England, a social enterprise whose vision is to improve the mental health of the nation. While Mental Health First Aiders are no substitute for counselling, medical care, peer (family/friends) support or treatment, they provide mental health first aid using the five-step MHFA action plan with the acronym ALGEE:
A – ASSESS for risk of suicide or harm.
L – LISTEN non-judgementally.
G – GIVE information and encouragement.
E – ENCOURAGE professional help.
E – ENCOURAGE self-help or other support.
Learnings from the Mental Health First Aiders at Nucleus Global
Through their roles in Nucleus Global’s health and wellbeing initiative, Moran and Murphy have learnt that:
- People tend to reach out when they’re at a crisis point – it would be good if people recognised the signs earlier and didn’t feel ashamed to be having conversations around mental health.
- Some people feel more comfortable in speaking about their mental health than others.
- People don’t always want to have a face-to-face conversation to discuss how they’re feeling; some prefer the phone, email or instant messaging.
- Even if people don’t need to reach out to the Mental Health First Aiders, they feel reassured that they’re available.
- Feedback from new starters revealed that they were impressed with the company’s commitment to mental wellbeing.
What can employers and HR do?
Moran gave a rundown of what employers and HR can do to prioritise mental health:
- Start conversations around mental health in the boardroom and in one-to-ones NOW.
- Be aware of the mental health statistics, how it may affect your employees and the correlation between wellbeing and productivity (and therefore the bottom line).
- Show acceptance of mental health: if an employee had a visible problem such as a broken leg, for example, they would undoubtedly get multiple offers of help – the same should happen in the case of a mental health issue.
- Do not be judgemental.
- Show leadership by providing education and work towards a healthy working culture.
- Develop policies and procedures (but also follow up with actions).
Take care of your mental health
“Start with yourself and look after your own mental health and mental wellbeing” advocated Moran, who gave the following tips:
- Connect: connect with people.
- Routine: stick to a routine. This can help to focus and build good habits.
- Active: keep active.
- Switch off: switch off from the news and social media.
- Time: practice mindfulness.
- Distraction: take up a hobby.
- Get out: get as much sunlight and fresh air as possible.
- Balance: separate work from home life.
- Breaks: take regular breaks from your computer screen – home is no different from the office in that it’s OK to be away from your desk.
- Diet: eat well and stay hydrated.
Key messages to take away
Moran urged participants to:
- Start with yourself – take care of your own mental health and mental wellbeing.
- Start talking – break the taboos around mental health.
- Organisations should take a proactive and preventative approach to mental health.
Murphy implored that participants:
- Be open and honest about not being OK sometimes (and line managers need to be OK with hearing that).
- Commit to making at least one positive change for your mental wellbeing.
- Don’t underestimate the impact of the pandemic on everyone.
Written as part of a Media Partnership between ISMPP and The Publication Plan, by Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers.
With thanks to our sponsor, Aspire Scientific Ltd