15 April 2021

Virtual 17th Annual Meeting of ISMPP

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Day 3 key take-homes and insights

Patient engagement in a post-COVID world

The global COVID-19 pandemic has increased our dependence on digital platforms for work, school, socializing and even for accessing healthcare.

The convenience of remote access could allow for a more efficient healthcare system because people require less direct support to utilize certain services. It also increases access because patients do not have to travel for all appointments. Clinical trials also expanded the use of virtual methods during the pandemic. Using virtual tools allows patients to record information more often without having to travel to a specific location, and it increases the pool of potential participants.

However, some individuals struggle to access or to use digital services, or they prefer the support and reassurance that comes from face-to-face interactions. This means that reliance on purely remote systems could exclude many people from fully utilizing health services.

Social media has been a major distributor of information about drug development and the pharmaceutical industry throughout the pandemic. It is vital that companies make evidence-based information easily assessable, quick to understand and shareable to ensure the general public is correctly informed about current progress.

The pandemic has accelerated technological developments by years. While this makes accessing healthcare and information easier for many people, for others it poses greater difficulties. Consequently, the full range of individuals requiring these services must be considered in future developments.

Summarized by Elizabeth Coe, Associate Medical Writer

When social distancing meets social networking: how societies are embracing the new digital world

Owing to the COVID-19 pandemic, most academic conferences either had to be cancelled or transferred into a virtual setting in 2020. The panelists (Angela Cochran, American Society of Clinical Oncology; Jennifer Regala, American Urological Association (AUA) and Alex Zapple, American Society of Nephrology) provided their experiences of this shift to virtual meetings and what the future of conferences may look like moving forward.

Key learnings

  • Benefits of virtual meetings include increased accessibility and inclusivity; members who have caring responsibilities and/or work commitments are able to join more easily.
  • Challenges of virtual meetings include reduced networking opportunities and reduced engagement. Therefore, a more pro-active approach is needed to keep attendees engaged, e.g. Zoom yoga, virtual treasure hunts and online networking platforms.
  • To maintain engagement, consider offering virtual programmes over a longer period of time, e.g. AUA is going to be held virtually over a period of months concluding with an in-person conference.
  • Ensure content and talks span a number of different time zones and that the content is available for a period time after the talk so that attendees can catch up later, if needed.
  • Looking forward, it is likely that hybrid virtual and in-person conferences will become the norm. To prepare for this, innovative and adaptative approaches needed as we transition into this new way of working.

Future-proofing your organization with digital transformation of medical communications

The evolving technology landscape and concomitant change in digital competence and habits of stakeholders has underscored the importance of digital transformation in our industry. The increased urgency for information delivery and the physical workplace restrictions resulting from the COVID-19 pandemic has spurred a transformation that will redefine the work environment of the future.

Digital transformation is driven by multiple factors, including information overload and the need for intelligent information distillation, changes in the modes of content consumption by end users (“bite sized” information and social media versus lengthy articles), emerging audiences (such as patients), and new technology platforms that efficiently disseminate vast amounts of information. The challenges are enhancing accessibility of content by assessing information delivery preference of end users, aligning content with audience needs, broadening content accessibility to diverse audiences, and improving communication efficiency both internally and externally.

Therefore, the digital future is one with an increased implementation of digital models for scientific engagement to prioritize reaching audiences using their preferred formats and platforms, and one that utilizes new ways to facilitate peer-to-peer interactions and collaboration with regulatory or client teams. Digital transformation is much more than technology integration. It begins with an assessment of business needs based on audience experience (how stakeholders interact with the company), and a clear vision of the present and future direction of the company. A core component is a cultural transformation that creates a supportive work environment and emphasizes operational agility to encourage employees to adopt new ideas, change behavior, and develop digital skill sets.

While the task of digital transformation may seem daunting, best practices recommend that it begins with smaller pilot projects that can be used to gain actionable insights using metrics that assess value and impact. Successful projects can then be expanded with improved internal communications and technological upgrades to ensure broad access to resources. This is necessarily accompanied by upskilling a diverse set of stakeholders with both soft skills (such as adaptability, accountability, emotional intelligence, complex communication) and technological skills to support project growth. While failures may occur, they provide valuable insight into approaches that would provide value to determining the best approach suited to each individual organization.

Tips for effective manuscript writing and feedback

This presentation started with an overview of the steps in manuscript development and the setting up of an ideal timeline. In addition to working backwards from the target date for the timeline, the speaker noted that it is valuable at this point to discuss any time that the authors may be out of office or on holiday to avoid possible unpredicted delays.

During the kick-off meeting, it is useful to review the International Committee of Medical Journal Editors (ICMJE) recommendations and the latest update of the Good Publication Practice (GPP3) guidelines. By the end of the kick-off meeting, the following items should be established: team, authors and stakeholders, responsibilities, manuscript type and journal, audience, timeline and key take-aways.

Other advice included the following.

  • During development of a publication, contronyms should be avoided or must be clearly defined. The following are examples: consult, clip, overlook, oversight, put out, sanction, screen, transparent and variety.
  • Consider different types of tables and graphs/charts, and ideal ways to display information clearly and concisely. Optimize readers’ retention of relationships in flow diagrams/figures by varying color in related elements.
  • Consider avoiding “alter” or “alteration” because they don’t indicate direction or amplitude.
  • Consult guidelines for reporting methods, including EQUATOR for clinical trials, ARRIVE for animal models, MIBBI for biological and biomedical investigations, and target journal guidelines.
  • Consult a decision tree (an example was presented) to place essential methodology in either the main methods section or in supplementary files.
  • Consider using words for search engine optimization in the title and abstract.

Explain what is expected at each stage of manuscript development (outline, drafts, final) and note that comments for revisions at each step should be clearly actionable, but also considerate in wording. Reviewers may have different priorities; with internal reviewers focusing on scope, accuracy and flow, while authors focus on data, clarity and context.

What is next for the FDA and what will it mean?

From 2009 to 2019, the US Food and Drug Administration (FDA) had a dynamic period with strong leaders, good budget and high pace of approvals of initiatives to guide clinical trial design. However, 2020 was a challenging and damaging year for the FDA due to the impacts of COVID-19 and political attacks. Looking ahead in 2021, a new commissioner will be appointed by President Biden to rebuild the FDA’s credibility. The new commissioner is likely to have a lot of experience in the FDA and have a science-led focus. Priorities for the new commissioner will include the continued COVID-19 response, drug approvals (e.g. COVID-19 vaccines/drugs, and clinical trials and approvals delayed owing to the COVID-19pandemic), modernizing clinical trial designs, and facilities inspections. Other challenges for the FDA moving forward, include catching up on tasks and inspections delayed owing to the pandemic, addressing vaccine hesitancy in the USA, understanding and addressing the impact of COVID variants, and getting ahead of social media and 24-hour news.

What makes us an award winning HealthScience consultancy?

Our services are transformative: we’re experts in publications, medical affairs, informatics and patient engagement. Our people are extraordinary: we help clients to bring new treatments to the world in areas of unmet medical need. Our vision is powerful: we’re shaping the future through transparent and accessible research.

Take a look at what we do

14 April 2021

Virtual 17th Annual Meeting of ISMPP

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Day 2 key take-homes and insights

Opening remarks & keynote – writing for equity & inclusion: the role of empathy in medical communications – Georgia Palmer (Project Coordinator, Oxford PharmaGenesis)

Medical communications are reaching a wider audience than ever before, including diverse stakeholders, patient organizations and patients; therefore, inclusivity in writing has never been more important. Stacy Robson (cofounder of CommunicateHealth) took the audience through a presentation explaining the importance of using empathy and inclusivity in our writing to enable the audience to feel heard and seen. Demonstrating empathy to patients has been shown to increase medication adherence and to improve patients’ satisfaction, emotional health and symptoms, so it is vital to continue to do this.

Everyone has unconscious biases and, consequently, all medical communications contributors should make conscious, active decisions to encourage empathy, inclusivity and transparency in their writing.

Top tips

  • Use the correct language.
    • Sex and gender: ‘sex’ is biological; ‘gender’ is social.
    • Male/female: instead of writing ‘X was born male/female’, use wording such as ‘X was assigned male/female identity at birth’.
  • Make a conscious effort to check that pronouns are correct; if unsure, consider using ‘they’ in a singular context or alternating between ‘he’ and ‘she’.
  • Use the right level of specificity regarding identifying factors.
    • If it is not relevant, do not include it, for example, ‘doctor’ instead of ‘female doctor’.
    • However, if it is important to demonstrate results, do include it, for example, ‘patients from lower economic backgrounds experienced …’.
  • Use person-first language, for example, ‘a person with a disability’ instead of ‘a disabled person’.

Ask the experts – the use of technology tools in accelerating scientific evidence dissemination – Elizabeth Coe (Associate Medical Writer, Oxford PharmaGenesis)

Artificial intelligence (AI) is becoming increasingly involved in all stages of drug development. By picking out previously unrecognized patterns from large volumes of text or data, new information can quickly be identified. Identifying novel biomarkers quickly, repurposing existing drugs to target alternative diseases and accelerating personalized treatment were a few benefits mentioned.

Machine learning, a subtype of AI, can be used to optimize clinical trials, a currently costly and unsustainable part of the drug development process. AI can identify the patients who are most suitable for clinical trials to increase the likelihood of successful treatment. Also, utilizing smartphones or wearable devices to set reminders and to record data can improve patient adherence. Improving the likelihood of a successful clinical trial not only saves time and money but also gets new therapies to patients quicker.

Knowledge graphs are another form of AI used in clinical research. They also bring data from multiple databases together into one place to identify previously unknown relationships; however, unlike machine learning, knowledge graphs make it possible to identify the sources used to generate any conclusions.

Finally, the advantages of AI also extend to the medical communications community. AI may be increasingly used as a tool to support literature searches and screening, and data extraction and analysis, as well as topic summarizing and publication of manuscripts.

The future of scientific writing and journal articles – with user-experience (UX) design – Alan Cowland (Medical Writer, Oxford PharmaGenesis)

Scientific journal articles have been developed under the current ‘IMRaD’ format (introduction, methods, results and discussion) since the 17th century; however, this ‘print-based’ format is not optimized for use on the internet. Adopting a user-experience (UX) design could revolutionize the dissemination and understanding of science.

The advent of access to published material through the likes of PubMed and Google Scholar has left scientists drowning in information and crippled by inexact search terms when interrogating unhelpful file formats. The proposal is that articles are fully in HTML format, a continuous text field of permanently updatable text into which machine readability can be coded at key points and for which review is more constructive. Information and data-presentation formats would be tailored to the reality of how people actually view and absorb information from a screen; in short, writing like a human, for humans.

Open-access formats would allow peer review from any expert anywhere in the world, and open comment can counter risks of overclaiming in the interpretation of results. UX design would enable information to be found more quickly and efficiently, and it has the potential to enhance understanding and increase accessibility. Furthermore, exploiting the potential of web-based information would encourage curiosity, enhance diversity and inclusion, and quite possibly speed up progress in science and medicine.

Equity, diversity and inclusion: defining a road map for our profession – George Gomez (Medical Writer, Oxford PharmaGenesis)

The recent global COVID-19 pandemic has shone a spotlight on the importance of diversity and inclusion in clinical trials as well as on the dissemination of information to all sectors of the public. Our profession is motivated to improve global public health communication in line with the diversity in the populations of clients and patients. Truthful and accurate representation of the global community in clinical studies leads to better public health, improved health outcomes for patients and increased public trust in the scientific community.

We are in a position to advocate for diversity in representation in clinical trials; representation of the diversity of the patient population is critical in interpreting clinical trial data that affect patients worldwide. A spectrum of genetic and metabolic diversity exists in different clinical trial subpopulations. Therefore, inclusion of diverse populations in clinical trials helps to involve communities that are typically excluded in studies and enables clinical trial results to be more relevant in different socioeconomic, cultural and global contexts.

The involvement of patients and diverse populations in study steering committees, publication authorship or presentations could be a valuable tool in engaging all members of the public. When people can ‘see themselves’ in clinical trials and scientific presentations, it helps to build trust with patients and encourages them to become more active participants in the healthcare process.

The creation of open access plain language summaries that are broadly understandable by a large proportion of the population likewise facilitates the involvement of diverse populations. The use of inclusive, jargon-free and culturally appropriate language, deliberate pathways that attract and provide access to broad socioeconomic strata, and internet portal and social media outreach to diverse community sectors also facilitates the involvement of diverse populations.

Open access to clinical trial results and scientific literature promotes equity through accessibility because access to published content should not be dependent on socioeconomic status or life circumstances (such as living in a conflict area or a region with limited media access). Giving patients easy access to scientific content enables them to share their experience and expertise with healthcare professionals. The great public demand for information, accompanied by appropriate education and information dissemination, fosters the establishment of a trust relationship between industry and the diverse general public and strengthens the collaboration needed to improve global health outcomes.

Equity and excellence – George Gomez (Medical Writer, Oxford PharmaGenesis)

A diverse workforce promotes the economic success of our industry. Collaboration with individuals who have a mix of talents, skills, experiences and backgrounds fosters innovation by allowing people to think creatively while using diverse approaches to problem-solving.

Recruitment of a diverse mix of candidates can be facilitated by practices such as appropriate wording of job descriptions, training of interview panels, use of blind CVs (to avoid name discrimination) and  creation of support systems prior to onboarding. Since science, technology, engineering and mathematics (STEM) careers are often inaccessible to certain communities, and younger generations of students often have different priorities or value systems, our industry must adapt to these considerations and recruit diverse talent from non-traditional sources.

While a diverse workforce is beneficial for recruitment, workforce retention is a critical aspect of success. Mentorship facilitates retention because it helps to build relationships and creates deep connections between individual stakeholders. Mentorship could begin at any time (such as with university students) and continue throughout a stakeholder’s career. Relationships must be built across differences and generations so that all stakeholders can benefit and thrive as a result.

A diverse workforce engages employees by promoting a supportive work environment. This is aided by soliciting input from current employees on important issues or barriers to personal growth. Encouraging an employee to ‘bring their whole self’ enables them to ‘bring their best self’. This translates into increased economic viability because engaged employees are 43% more productive.

The finance and technology industries have developed best practice for networking with and recruiting a diverse workforce via digital platforms. Organizations of any size can apply the best practice developed in these industries; it is important to make the commitment to implement, and ensure sustainable application of, this best practice.

Artificial intelligence (AI) in drug development – Kim Wager (Communications Consultant – Informatics and Data Science, Oxford PharmaGenesis)

Oxford PharmaGenesis’ own Kim Wager presented a session on artificial intelligence (AI) in drug development.

From the ancient Greek automata to AlphaFold’s incredible accuracy for predicting protein folding, people have always been fascinated with the idea of AI and our ability to build machines that can imitate and surpass the workings of the human mind. In the past decade, this area has progressed immensely, and the uses for AI in drug development are many.

AI can be utilized throughout the pharmaceutical product lifecycle and has the potential to revolutionize the often lengthy and expensive drug development landscape. In terms of early drug development and discovery, AI can help accelerate early R&D and inform portfolio decisions. It can be involved in literature data mining, target predictions, structured-based design and for optimizing screening protocols. Some examples of questions that AI can help address in these early stages include: What are a set of targets for a given disease area? Which compounds might be good for which target?​ Which type of biological pathways could be considered?​ What relationship might a gene have with a set of diseases and drugs?

Beyond drug discovery, AI can help optimize clinical trials and their outcomes. AI methods can be implemented to improve patient-trial matching and recruitment, adherence to trial methodology and endpoint assessment; all common clinical trial pitfalls that can arise during patient selection/recruitment and trial management.

Finally, AI can support and improve many areas of the publication professionals’ work through literature searches and screening, as well as data extraction and analysis.

What makes us an award winning HealthScience consultancy?

Our services are transformative: we’re experts in publications, medical affairs, informatics and patient engagement. Our people are extraordinary: we help clients to bring new treatments to the world in areas of unmet medical need. Our vision is powerful: we’re shaping the future through transparent and accessible research.

Take a look at what we do

13 April 2021

Virtual 17th Annual Meeting of ISMPP

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Day 1 key take-homes and insights

Unused vaccines can’t save lives – embracing an opportunity to overcome vaccination hesitancy in the midst of a global pandemic – Alan Cowland (Medical Writer, Oxford PharmaGenesis)

The response to the COVID-19 pandemic clearly demonstrates that public trust is necessary for sufficient participation in a mass vaccination campaign to ensure its ultimate success. The production of effective vaccines in a short timescale has been remarkable, but levels of public trust in governments, business and healthcare systems remain low in some parts of the world. To address the issue, effective communication is essential.

The language of clinical trials and vaccine development has become mainstream in a short space of time. However, this has not necessarily been accompanied by an accurate understanding of the terminology. As such, public education in the use of terms such as ‘severe adverse event’ is necessary. There is also a requirement for wider use of plain language, either in the form of alternative versions of documents, such as clinical trial summaries, or by ensuring that press releases use language that is more widely understood.

The need for clarity and transparency from pharmaceutical companies is paramount. The timing of the release of information has also proven to be critical, balancing a need for honesty with a desire for completeness.

A large gap remains between the general public and the accurate communication of public health information, requiring a proactive approach. Social media is a highly emotional environment whose commentators need to be heard and engaged with. This offers the opportunity to apply an innovative solution by using members of the scientific and medical community to engage with the public on these platforms.

Keynote: The public face of science – building trust – Eleni Tente (Associate Medical Writer, Oxford PharmaGenesis)

Public distrust in healthcare systems, directed towards physicians, regulatory authorities and the pharmaceutical industry in general, has increased in recent decades. In addition, the diffusion of selective and often non-peer-reviewed information via mass media can add to misinformation and negatively shape public perception of healthcare systems. Public rejection of medical and scientific findings has major consequences for current public health but may also threaten future medical innovations that rely on clinical research led by pharmaceutical companies.

The presenters identified patient engagement and open access publication as the key components for building trust and bridging the gap between researchers and the data presented for public consumption

Pharmaceutical companies should endeavour to understand who their target patients are and engage with them in a transparent and sustained way. This can be achieved by adopting the practice of structuring studies through patient engagement plans. Furthermore, transparency can be improved if more pharmaceutical companies commit to mandatory open access publication, which would ensure that peer-reviewed data becomes widely accessible.

A preprint pandemic: the evolving role of preprint servers in the COVID-19 era & preprint debate – to preprint or not? – Rebecca Burge (Associate Medical Writer, Oxford PharmaGenesis)

The number of biomedical and life sciences manuscripts submitted to preprint servers has surged during the COVID-19 pandemic, raising questions as to the regulation of preprints in medical publishing.

Preprints have the potential to accelerate scientific research by allowing it to reach larger audiences more quickly and by facilitating input from a wider range of researchers. However, preprints are not peer reviewed, and the misinterpretation of preprint data by the media or the public could reduce trust in science. In the pharmaceutical industry, liability concerns surrounding data misinterpretation and off-label misuse must also be considered. For these reasons, academic and industry preclinical data are considered more suitable for use in preprints than clinical trial data.

However, much can be done to mitigate the risks associated with preprints: preprint servers can implement prominent declarations on preprint articles, perform more rigorous checks for health science manuscripts and consider what ‘do no harm’ means in the context of preprints. The American Medical Writers Association, European Medical Writers Association and International Society for Medical Publication Professionals also suggest citing preprints as personal communications, clearly distinguishing preprints from peer-reviewed articles and standardizing screening procedures across preprint servers.

At the end of the session, audience members were asked to offer their opinion on preprints; just under half of respondents (44%) voted in favour of preprints, whereas the remainder (56%) voted against their use.

What makes us an award winning HealthScience consultancy?

Our services are transformative: we’re experts in publications, medical affairs, informatics and patient engagement. Our people are extraordinary: we help clients to bring new treatments to the world in areas of unmet medical need. Our vision is powerful: we’re shaping the future through transparent and accessible research.

Take a look at what we do