What a lay summary of trial results is for, and who reads it
A lay summary of a trial's results can do more than meet the EU requirement: it can inform and thank the people who took part, and answer what participants and the public expect. Its readers want the results for reasons of their own, their health literacy differs from that of the regulators a writer usually serves, and the summary reaches them only if they can find it.
What a lay summary is
A lay summary is a short document that gives important information about a clinical trial in language the public can easily understand. Understanding clinical studies matters to patients as well as to healthcare professionals, but whether participants can understand the technical terms used is a major concern. Lay summaries were created to address this concern, and they briefly explain the results of a clinical study in non-technical language. The layperson summaries that the EU Clinical Trials Regulation requires describe the designs and results of individual clinical studies using plain language, figures and pictograms.
A lay summary is designed to make clinical research results more accessible to non-scientific audiences by translating complex medical information into plain language. Its aim is to turn complex clinical information into clear, concise and understandable documents for the general public. It explains the results of a clinical trial and what the sponsor believes they mean. It increases transparency and makes trial results accessible and understandable to participants, patients, their caregivers and the wider public.
The obligation to share results
The European Medicines Agency's mandate for plain language summaries of trial results is part of its transparency and inclusivity initiatives to promote patient engagement in clinical development. The European Medicines Agency holds that the lay summary should offer patients and the public an unprecedented chance to understand what is going on in medical research, while also allowing sponsors to communicate their results in a more harmonised way. The requirement for it reflects ongoing efforts to increase transparency and acknowledges the important contribution patients make to the advancement of medical research.
The European Medicines Agency has stated that the clinical research industry has a binding legal obligation and a strong moral one to communicate results to the individuals in trials. The Declaration of Helsinki considers the dissemination of clinical study results crucial, and states that all medical research subjects should be given the option of being informed about the general outcome and results of the study.
Regulatory mandates underscore the importance of communicating trial results accessibly, so that patients can make informed decisions about their healthcare. Patient-centricity and transparency are not new, but they are increasingly important in regulatory documentation. Their implementation has been supported by various official guidance documents and mandated by legislation, to the delight of patient advocacy groups and the public in general.
The purposes a summary can serve
A lay summary need not be limited to the EU database, and its format, content and visual style can be tailored to a specific audience. Its purpose should be considered: whether to satisfy the regulatory requirement, to thank participants personally for their involvement, or to inform interested patient communities about potential new medicines for their condition.
The purpose of creating a plain language summary and disseminating it to trial participants is to ensure that they are informed about the trial results, that they know their participation is respected and appreciated, and that they understand the value of their contribution to science and public health.
What a summary does for participants, the public and research
Sharing trial results with participants through lay summaries, directly or by posting them to online portals, is of great value to participants, to those involved in medical decision-making, and to pharmaceutical companies and other research sponsors. It has the potential to improve health literacy, empower patients and build public trust, particularly in the pharmaceutical industry. Communicating with patients in this way may also promote participant engagement, recruitment, enrolment and retention in trials. A plain language summary helps people make informed decisions about their healthcare and take a more active part in shared decision-making, it fosters trust between the public and the pharmaceutical industry, and it is a valuable resource for patients, caregivers and patient advocacy groups seeking information about particular interventions or conditions.
A summary lets patients know what happened in the study. Informing patients of the results may give them a more positive experience of having taken part.
Trust and recruitment
A summary can increase public awareness of the clinical trial process and trust in it. Lay summaries reinforce patients' trust in clinical research and help recruit participants for future trials. They are critical for building public trust in clinical research and therefore for recruiting patients. A summary can also bring a greater desire to take part in trials. Informing patients of trial results may improve low recruitment rates.
Health literacy, education and decisions
Although lay summaries are another commitment for pharmaceutical sponsors, they have the potential to play a role in improving health literacy in the general population. Making the results of clinical research available to patients and the general public is critical for improving awareness and therefore health outcomes, and lay summaries do this by giving the results in plain language.
Lay summaries have the potential to be key decision-making tools: an informed patient often makes different choices about their healthcare. With ever-increasing importance placed on shared decision-making, patients increasingly look to lay summaries to help inform their healthcare journey, and a summary that directs the reader towards a discussion with their clinician can support this.
Lay summaries will play an important role in educating patients about clinical research. Distributing one would be a great opportunity to educate patients about clinical trials, helping form a win-win relationship in drug development. One team of writers holds that enhancing patients' literacy about drug development would help advance patient centricity in the pharmaceutical industry. Increased transparency about clinical trials and their outcomes would allow trials to be conducted more effectively and ultimately lead to faster drug development.
Transparency
A summary is also an important part of efforts to improve transparency. Through transparency, it helps improve the overall quality of clinical research. By putting trial results in a form that diverse audiences can access and understand, it plays a crucial role in promoting transparency and accountability in clinical research. Plain language summaries play a pivotal role in enhancing transparency and promoting patient engagement in the clinical development process. Accessible-language documents, the lay summary among them, are central to improving transparency in reporting clinical trial data in regulatory documents and publications. Efforts to improve transparency come as the pharmaceutical and adjacent industries increasingly recognise the value of patient and public involvement and non-expert engagement, and the role accessible language plays in enabling dialogue between stakeholders.
For better or worse, lay summaries are likely to be influential documents, and they need to be written with care. There is some evidence that too much safety information may negatively affect compliance and that primary health care workers may be inundated with questions. But there is hope that improved transparency will help regain patients' trust by restoring a sense of autonomy in their own treatment decisions, and may improve trial recruitment.
The opportunity for the pharmaceutical industry and its writers
The EU Clinical Trials Regulation has been seen as a welcome opportunity for the pharmaceutical industry to deliver clinical study results to the general public, and especially to patients, but there is a danger that the opportunity will be wasted because writing for a lay audience is very challenging. Plain language materials are finally being recognised and understood as essential tools to provide patients with effective treatment options. How to produce them so that they are fit for purpose, and not part of a regulatory box-ticking exercise, is both an opportunity and a challenge for the whole pharmaceutical industry. Demand for better information for patients and the general public is increasing, and regulatory authorities are reflecting and responding to it. The pharmaceutical industry now has the opportunity to engage directly with the general public in a way forbidden up to now. If the opportunity is used correctly, patients and the public will have access to unbiased, trustworthy information that is evidence-based and easily digestible.
A regulatory writer's role is often limited to the more technical, submission-level component of either a trial design or a trial outcome. Plain language summaries, also known as patient lay summaries, give that writer a unique opportunity to inform the clinical trial patient population directly, and in turn the wider public.
In a globally connected society well into the digital age, expectations have shifted with the arrival of accessible and contemporaneous information, particularly in developed countries. Most medical writers are used to scientific writing within the confines of regulatory requirements, and they now have an exceptional opportunity to inform other audiences. Drawing on the legacy of plain language and keeping clarity in mind, they may influence perceptions of clinical research and make a difference to the lives of patients and of the wider population.
Partnering with patients and patient advocacy groups can certainly help the pharmaceutical industry address some of the current and future challenges. Continued collaboration among stakeholders, including patients, researchers, regulators and the pharmaceutical industry, will be essential to optimise the utility and impact of plain language summaries of trial results in fostering a culture of transparency, accountability and patient-centred communication in clinical research.
What participants and the public expect
In a global survey run in 2017 by the Center for Information and Study on Clinical Research Participation, of more than 12,000 respondents including patients and members of the general public, 85% valued clinical studies for developing new medicines, 90% considered clinical studies to be safe, 84% thought it important to be aware of the clinical studies being conducted in their communities, and 91% believed it important to receive a summary of a study after they had taken part in one. The information would therefore appear to be wanted and needed by the general public. Research also highlights a demand from participants for timely and accessible communication of trial results.
Trial participants want to know and understand the results of the trials they took part in. The information recognises their contribution, can help them better understand the facts about their trial, and may affect their willingness to take part in future trials. One expert holds that researchers who fail to share study results effectively do not hold up their end of the deal. Such a failure can negatively affect future participation in studies, and it marginalises the participants. There is also evidence that patients who are not informed about results may not take part in future trials, and that at the end of a trial they no longer feel valued.
Trial participants and the general public should be, and increasingly demand to be, informed about the results of trials. This is crucial for them to share in and be involved in decisions about their own healthcare. But results are usually discussed and disseminated in scientific journals, regulatory documents and conference presentations, which are primarily aimed at healthcare professionals, the pharmaceutical industry and researchers. These formats are often full of technical terminology and complex statistical analyses that are extremely difficult for non-experts, such as patients and the general public, to understand and interpret. The technical or scientific summaries that sponsors are required to post on public registries, such as the EU Clinical Trials Register and ClinicalTrials.gov, are written in a language and format that most trial participants cannot understand. Much of the published clinical research information can be understood only by those with scientific or medical training. That knowledge gap hinders informed decision-making and limits patient engagement both in healthcare decisions and in clinical development. A plain language summary serves as a bridge between the technical language of clinical research and the everyday language of patients and the general public.
Legislative requirements aside, the quality of a lay summary can be benchmarked against whether it meets what a patient wants and needs. What industry and clinicians think a patient wants can differ from the reality, especially when it comes to patient input into their own healthcare.
Who reads the summary and why
The layperson summaries that the EU Clinical Trials Regulation requires are written for interested readers with limited health literacy or scientific expertise, to help them understand clinical study results. The primary audience for lay summaries is the general public, who should not be assumed to have any prior knowledge of medical terminology, clinical research or the specific context of the study, and a summary needs to be understandable to people with low literacy skills. A lay summary summarises the results of one clinical study, and its target audience is not only the people who took part in the study but also the general public. A plain language summary is not only for the general public but also for past trial participants eager to understand how they contributed to the advancement of treatment strategies for their condition.
People want the results for various reasons. As participants, they may want feedback on the scientific research they contributed to. They may seek information to decide whether to start or continue a treatment, to interpret symptoms or to find an alternative treatment. Others may want to find out whether there is a trial they could join, or seek information to pass on to others, such as loved ones or doctors.
Writers who create these summaries are likely excited about the clinical research enterprise, and participants do want to learn the results of their trials, but the participants' main interests lie elsewhere. One patient, a highly educated diplomat who spoke and read several languages, was diagnosed with double-hit lymphoma; the prognosis was poor, and a stem-cell transplant trial was his best chance of survival. He and his wife were not concerned with how they could advance clinical research; they were focused on his "new birthday", the date of the transplant. As his son-in-law said at the funeral, "He wanted to live." The world of medical research was not one they chose to enter, and had he lived to receive a summary, he would likely have skimmed it, tossed it on his desk and returned to work. A participant in a pembrolizumab trial, asked why he joined, answered that he was 40 years old, had children and had lung cancer, and would have tried anything.
How these readers differ from the readers of regulatory documents
The readers of the complex, data-rich documents that regulatory writers produce have high general literacy, a very high level of health literacy, high science literacy, often considerable knowledge of the disease or therapy area, and a strong interest in the data and results. These readers are nearly the opposite of most members of the public. Writing instead for readers who may have low health literacy and perhaps little or no knowledge of the disease or therapy area is a significant challenge.
Plain language is vital when communicating with an audience of unknown and varied backgrounds, because it facilitates understanding and aids retention. Clinical trial volunteers are such an audience, and their need for clarity may be heightened by their clinical condition. In the US, readability studies suggest that consumer comprehension is compromised when content exceeds a seventh-grade reading level, which the US Department of Health and Human Services identifies as the average American reading level. Health literacy is a known variable across trial volunteers, so it is important for an author of these summaries to understand it and its effect on readability by region.
Where readers find the summary
A lay summary of trial results can be challenging to write, and however much it is needed, the effort is wasted if it does not reach or connect with its intended audience. To be fit for purpose, a lay summary needs to be understandable, relevant and accessible. Once published, it has to be easily accessible to its target audience: easy to find and available to all. Open-access sources are critical for this, so that the lay reader is not blocked by a paywall. It is incredibly frustrating for a patient to find information only to discover they cannot access it. Some sponsors already use an open-access model and mandate that all affiliated research is published in open-access sources.
Plans exist for a single upload portal for lay summaries, and it is of the utmost importance that the portal be advertised widely to lay audiences generally and to patients specifically. This should be done through as many channels as possible, such as healthcare professionals, national healthcare systems, charities and patient associations, and the sponsors' own websites. The participants in a particular trial should also be told that a summary of its results is available. A single portal should not necessarily be the only place a summary appears, and publishing it in several places, such as the sponsor's website, academic-sponsored sites and relevant research events, makes it more likely to be seen.
TrialScope, in partnership with AstraZeneca, has launched a Trial Results Summaries Portal where sponsors can post lay summaries for study participants and the general public.
When the official websites of 58 pharmaceutical companies were searched in August 2022, many of the companies' websites, portals and databases for indexing their lay summaries were not user-friendly. Some were not clearly labelled, and some took multiple clicks to reach the final documents, which made the search for the relevant information long and sometimes complicated.
Of the 58 companies, 25 had no mention of lay summaries publicly available online, yet at least two of these were known to be distributing lay summaries directly to their clinical trial participants. How many of the other companies with no information available online were doing the same is unknown. This indicates online transparency policies that are unclear and do not necessarily reflect practice. Companies headquartered in Europe, whether or not in an EU member country, and in Asia appeared more transparent online about their lay summary practices than those headquartered in North America.