In 2014, the European Medicines Agency (EMA) gave the first indication that layperson summaries of the results of pharma-sponsored clinical trials would become part of their mandatory requirements. This was part of a drive towards greater transparency of pharma-sponsored clinical trials, in which a layperson summary formed part of an overall package, including the clinical study report, to be submitted within one year of study completion. In 2017, the EMA provided greater clarity, stating that a layperson summary in a specified format must be submitted within one year of the end of all trials with an active site in the European Union. It is not yet clear when the legislation will become legally binding, but we are already observing how this change is helping to confirm patients as legitimate stakeholders in the communication of medical research.
In response to patient-centric directives, the International Society for Medical Publication Professionals (ISMPP), the global not-for-profit organisation for medical publication professionals, engaged in educational activities on patient involvement in medical publications as early as 2015. At that time, it was a somewhat divisive topic, with some members of the community viewing patients as not relevant to medical publications practice as they are generally not qualified to understand and critically appraise clinical trial results. However, in recent years there has been a growing recognition of patients as key stakeholders, not only in the conduct of medical research as trial participants but also in consuming the results.
The European Meeting of ISMPP has become a highly valued forum for sharing best practice and new directions in medical publications and scientific communications and as a bellwether for the future direction of travel of the industry in Europe. This year’s meeting in London on 22–23 January 2019 was no exception (for details see https://www.ismpp.org/schedule-of-events), and the discussions again centred around patient involvement as a key theme.
Importantly, this year we saw the discussions move from theory and principles towards practical experiences and insights as pharmaceutical sponsors and their medical communication partners transition towards building patient communications into their scientific communication practices. Key themes that emerged from the discussions are highlighted below.
The importance of format and design
There has been considerable work in recent years to quantify whether lay summaries are accurate, relevant and understandable for most lay readers.
Discussions at ISMPP EU 2019 suggested that, at least for some patients, a more infographic style may be preferred over the standard prose format. The advantage of more creative formats is the opportunity to reduce the amount of text and use colour, graphics, icons and design elements to enhance visual appeal and reinforce take-home messages.
Patients as a diverse group
While all would agree on the importance of avoiding jargon and technical terminology in lay summaries, it was surprising to hear that some patients may be comfortable with written content aimed at an advanced reading age, rather than basic text designed for a younger reading age. As with any other medical communications programme, it is important to consider the needs of the specific group to be targeted. We are starting to learn
more about how some patient communities may be particularly well informed about their disease area and ongoing topics of research, for example those with rare diseases.
Some patients are used to accessing the scientific literature and others are accessing those lay summaries that exist. It is possible that those patients and caregivers who are proactively seeking information about medical research are the more engaged and educated individuals within the overall patient population. Overall, there is a growing recognition that patients are a very diverse group that may have hugely varying informational needs, meaning that patient- focused programmes need careful design and opportunities for personalisation.
Patient engagement at scientific congresses
Presentation at scientific congresses is generally the first step in communicating clinical trial results to the healthcare professional audience. However, congresses are not a forum that patients and caregivers typically have access to and, in addition, after the event the posters, oral presentations and proceedings are often restricted to professional society members or behind a paywall. In some therapy areas, such as oncology, where the science is advancing very rapidly, congress presentations are a vital communication channel for sharing the latest clinical results. The American Society of Clinical Oncology (ASCO) is one of the first major congresses to permit plain language summaries alongside congress presentations. Initial experiences of providing lay summaries at ASCO appear to be positively received, and so it can be expected that other congresses may follow suit in the coming years.
Acknowledgement of patient contributions
While thanking the contribution of trial participants within the acknowledgements section of a clinical trial publication may be seen as trivial, it is now widely recognised as best practice throughout the medical publications community. Assessing acknowledgement of participants is an easily quantifiable metric that enables us to gauge the overall focus on patient engagement across the industry. Therefore, it was exciting to hear at ISMPP EU 2019 that most pharma-sponsored clinical trial publications in the oncology space now include a patient acknowledgement. We have made much progress in recognising patients but there is still some room for continued improvement in coming years.
The role of publishers
There are examples of individual publications such as the British Medical Journal that are exploring the potential for patient involvement throughout the publication process, for example by using patient peer reviewers, although this approach has not been adopted across the medical publishing industry to date. Some journals already publish
lay summaries alongside primary articles, but this is also not consistently done. For example, those journals that do publish lay summaries use a variety of terminology to describe them (including ‘lay abstract’, ‘patient summaries’ and ‘plain English summaries’) and the location of lay summaries in relation to the original article can also vary. A more consistent approach to both naming and storing lay summaries is needed to ensure patients and caregivers can retrieve and access them as needed.
In the past, interactions with patients and caregivers were perceived as challenging for the pharma industry, largely because of concerns of a perception of direct-to-patient promotion but also because of a perceived lack of impact on healthcare decision-making. However, the mandate from the EMA is driving pharma companies to
put in place new capabilities, partnerships and processes to deliver on their regulatory obligations. Some pharmaceutical companies are investing in advance of the regulations coming into force and will capitalise on this from both reputational and competitive perspectives. Conversely, those that are waiting for the legislation to come into effect before acting risk being left behind.
Importantly, pharma compliance teams have to find approval pathways that can enable patient engagement, even in a prelaunch environment. We see these capabilities increasingly moving away from the Public Affairs arena and becoming a core competency in Medical Affairs. As a consequence, there will increasingly be an established framework in most pharma companies that can enable deeper, more meaningful patient interactions throughout the product life cycle. At the early development stages, this may involve defining unmet needs and framing research questions. During clinical development, the most successful programmes will be the ones that provide the best patient experience and are able to recruit and retain patients most effectively. When supporting marketed products, companies that support patients with their practical and informational needs will be able to demonstrate greater overall value to prescribers and healthcare systems.
Pharmaceutical companies are identifying partners who can help them meet EMA requirements, but also support a broader commitment to engaging with patients. Healthcare communication agencies need to show that they have the right structure, skills and mindset to partner appropriately and bring value to both pharma clients and patient partners. At Nucleus Global, this has meant investing in patient engagement specialists with experience working in the patient advisory group environment, training for our teams so that we embed practices to deliver on patient engagement as an integral part of our core capabilities, and building frameworks that clients can directly input into their day-to-day business. As a medical communications industry, we should be excited about the possibility to deliver better value both to our customers and to the patients we ultimately serve.