Who writes and reviews a lay summary
Writing a lay summary of trial results takes both an understanding of clinical research and the skill of writing for lay readers, which differs from the skill set that regulatory writing builds. Medical writers are suited to the work, and most of those who write the summaries work in the regulatory space. A plain-language editor and regulatory and legal reviewers may work beside the writer, who may have to balance the sponsor's interests against the patients'.
Why medical writers suit the work
Writing a lay summary of trial results requires expert understanding of clinical research and the skills of communicating with lay audiences, so medical writers are ideally suited to it. Writing for a lay audience requires not only an understanding of the science but also the skill set to communicate it to a non-scientific audience. Professional medical writers understand the clinical trial process and the importance of trial transparency and disclosure, and they can convey complex information clearly, so they are suited to conveying trial outcomes to participants and the wider public. One writer holds that writing plain-language summaries is surely a work opportunity for medical writers not to be missed.
Annex V of the European Clinical Trial Regulation gives only scant guidance on the content of a lay summary, and most of its ten items need interpretation and adaptation, so there is a large potential for professional medical communicators to contribute. Medical writers can support the implementation of the requirements by developing lay summary templates and providing expertise in writing in lay language. In the quest for transparency and patient-centricity, medical writers are clearly set to play a crucial role.
The skills the work needs
Producing the summary of clinical trial results, like producing section VI.2 of the risk management plan, typifies the challenges that the need and desire for greater transparency in the pharmaceutical industry bring to medical writers. A medical writer writing for a lay audience determines the appropriate level of granularity, teases the key messages out of the data and presents them clearly and accurately. The job is the same whether the reader is a regulatory authority or a member of the public, but the words chosen, and the way they are explained and expressed, differ dramatically between the two.
Presenting data and messages so that a lay audience can both understand and use them requires a medical writing skill set that differs in many ways from the one used for regulatory documents. Presenting them for use in the audience's own healthcare decisions is a huge responsibility. Writing in lay language is far more than translating clinical words into simpler ones, particularly when benefit and risk are discussed.
Writing plain-language summaries of trial results is a new area of medical writing that will require many writers to acquire and develop different writing skills, so the writer needs to appreciate the audience and understand how to communicate complex trial results in language a layperson can understand. A writer preparing plain-language summaries will need to learn the new skills of writing for patients or a non-scientific audience, such as applying health literacy and numeracy principles. The writer will also need to learn to summarise results clearly, concisely, correctly and completely, while considering the appropriate length of the summary. The writer may also be required to learn to create simple visuals that explain the trial results, or to work with illustrators or designers on custom visuals and graphics.
Regulatory writers taking on the work
Most writers tasked with creating plain-language summaries of trial results work in the regulatory space. They are trained and accustomed to creating complex, data-rich documents for readers with high general literacy, high health and science literacy and a strong interest in the data and results, readers who are nearly the opposite of most members of the public. Those who have traditionally developed technical study reports may not be best suited to developing lay summaries of clinical trials, because their frame of reference has been almost exclusively high-level scientific language.
Patient education is a small sub-field of medical communications. It requires different techniques and aptitudes from regulatory writing, as well as familiarity with the principles of health literacy, readability and usability.
As demand for the summaries grew, more writers were needed. Specialists in patient education make up a small fraction of medical writers in the United States, and because the regulatory environment already had many writers available, it seemed logical for regulatory writers to take over most of the work. The solution seems natural, but scientists and non-scientists differ in perspective and in what they perceive as accessible writing, and these differences present some hurdles.
Editors and reviewers beside the writer
With a plain-language editor on the team, a regulatory writer can produce the first draft of the summary and have it edited for readability, ensuring that both the science and the accessibility are top-notch. The EMWA and AMWA directories can help a writer find plain-language and patient education specialists.
Although medical writers are good candidates for writing lay summaries, regulatory and legal input may be warranted, because language that could be perceived as promotional is clearly a concern.
Working with the sponsor
Research sponsors are responsible for the study design, objectives, endpoints and interpretation of results, and their input is vital to a summary that reflects the trial findings accurately and to a precise interpretation of complex data. As public access to trial results increases, a summary that an external party creates in isolation risks misinterpretation and the loss of important context. The absence of sponsor oversight has been shown to lead to misinterpretation or the omission of important details in the summary.
One of the biggest ethical concerns in writing for patients and the public is the source of funding and information. Medical writers must convey scientific information to patients and the public accurately, fully and non-promotionally while still meeting the sponsor's requests and needs for the project. The needs of the public and of the sponsor can often seem completely at odds. In one writer's experience, writing is a large part of the job, but learning to compromise successfully on complex topics to provide useful documents is more the task at hand. Compromise is an important skill for medical writers, especially those balancing the interests of trial sponsors and patients.
Detailed processes and templates that the writer and the trial sponsor agree to can prevent some difficult situations, such as deciding which endpoints or safety data to include in a plain-language summary, or whether to refer to a drug by its trade name. Mutually agreed processes and templates can also help keep plain-language deliverables non-promotional.
At the Center for Information and Study on Clinical Research Participation (CISCRP), much of the "friendly friction" with sponsors arises from disagreements over which data to include and over the overall messaging of the results, because the organisation strives to present results in a non-promotional, neutral way. With collaborative sponsors that respect its independent positioning and patient-centred approach, the friction is typically resolved after a brief explanation of why the organisation works as it does.
A medical writer must take seriously the duty of being one of the checks and balances on all scientific information that reaches the public. It is important that writers working with sponsors, or with other stakeholders with varied interests, feel comfortable enough to uphold the high ethical standards that come with writing for patients and the public.