Creating plain language summaries for clinical studies: how to strike the right balance for readers

    Written by Pooja Phogat, Head of Development Operations

The need to produce plain language summaries for clinical studies presents a challenge for life sciences firms, because these must appeal to a much broader audience than the main reports. 

This challenge can be broken down into 4 questions:

1. What’s changed?

To comply with requirements for greater transparency around clinical research, encapsulated in the the EU Clinical Trials Regulation 536/2014 (Article 37), life sciences firms must now prepare plain language summaries (PLSs) of their clinical studies that can be understood by lay readers as well as clinical experts.

The ambition is that anyone – from patients and their families to doctors and other researchers – can spontaneously look up and make sense of trial findings, via the specially designated central EU portal.

But writing for this extended readership – people who may know very little about the context or complexitities of the given trial – exceeds the parameters of traditional clinical study report preparation, creating new work for companies.

Reading Plain Language Summaries

2. Who will read the summaries?

Once de-identified clinical study reports and summaries are published on the central EU portal, they are open to public scrutiny to satisfy both general curiosity and the specific interests of:

  • Patients who have participated in the trial

  • Other patients affected by the medical condition studied in the trial

  • Patients’ care givers or family members

  • Members of patient advocacy groups

  • Doctors and physicians

  • Researchers

  • The general public

3. What do I need to include?

The idea of the PLS is to pre-emptively and concisely answer any questions the average person might have about a clinical study and its findings – which they might struggle to do from a lengthy, detailed and technically-complex report written for a clinical audience.

Study volunteers have a right to know how their participation and contribution helped answer important medical questions. At the same time, in keeping with the spirit of transparency, companies need to be as open as possible about the clinical work they are doing – which means making findings readily accessible and understandable by anyone.

EMA has provided guidance about the main elements that sponsors must include in their PLSs. Yet, in our experience, it is still challenging to judge what really needs to be included. For this reason, we have developed a way of framing discussions with the PLS author and reviewers to agree appropriate content.

To avoid summaries becoming overly lengthy, it’s important throughout the development of the PLS to question and challenge what’s being included and why. For instance:

  • Which endpoints need to be included to explain the key study results?

  • How much information is necessary to explain what happened in the study?

  • How much information is necessary to give a brief background to the study, the treatment being studied and the volunteers who took part?

  • How were safety concerns addressed?

  • How were affected patients supported?

  • What happens next (e.g. future studies for the treatment, extension or follow-up studies)?

  • Where can the reader find more information about the study?

4. How do I decrease the complexity of our information?

EMA has recommended that PLSs are geared to a minimum level of literacy.

We recommend the following to help make the PLS simple and meaningful for a wide audience:

  • Provide numbers to explain the results and, if possible, further context/guidance text

  • Make the maths clear to the reader (e.g. 0.1% means 1 in 1000 people).

  • Use simple graphs as a means of illustration.

  • Stick to the facts/ avoid promotional content.

  • Avoid jargon. If complex terms are unavoidable, explain them using straightforward language.

  • Use short sentences.

  • Provide a summary at the beginning.

  • Use a simple and clear design.

  • Avoid text density by allowing for white space.

Although the demands of EU CTR Article 37 are considerable, with the right help and advice upfront companies can avoid PLS preparation becoming burdensome.

Find out how Kinapse could support your PLS preparations

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2018-08-13T15:43:18+00:00