Saying what one trial's results cannot tell the reader
A lay summary reports the results of one trial, and readers may take them for more than they show. So the summary states the limits of that one trial, places its results in the drug's development programme, and tells readers what to do before changing their therapy.
Reading too much into one trial
The most important concern for lay summaries is that the general public may misinterpret the results and draw conclusions that go beyond the study's limitations. People unfamiliar with clinical research might be in danger of drawing far-reaching but unwarranted conclusions. For example, it is inappropriate to conclude from the results of a single study that a drug is beneficial. Readers may also come to a lay summary with different expectations: some may want to know whether medicine X is safe, what will happen to them if they take it, whether X is better than Y, and whether they should change their therapy.
The trial's place in the development programme
A lay summary presents a trial's results to lay readers as a stand-alone piece of work, without the context of clinical development. To make sense of those results, lay readers need the medical writer's help. Presenting only the results assumes that readers have enough clinical knowledge to extrapolate them into medical outcomes. So the summary should give some context or explanation that lets readers translate the findings into what they mean for them: the risks of harm and the benefits of taking the drug. This must be done without bias, and in the context of the trial and of the therapy area in general.
Regulators and the pharmaceutical industry do not assess a drug from the results of one trial, and it could be dangerous, and is certainly inappropriate, for lay readers to make assumptions from those results alone. This is a particularly difficult challenge, and preparing the summary will need extensive discussion to address it. Meanwhile, medical writers are tasked with presenting this information clearly and without bias.
Readers benefit when the summary explains which stage of development the trial represents, for example with a marker on a timeline or a section headed “What does this mean for me?”. The explanation helps them understand whether the treatment will be available imminently or not. The public and many patients are unaware of the complexities and timelines of drug development. A summary that reports, for example, a positive Phase 2 trial could leave a reader mistakenly believing that they can go to their doctor and ask to be prescribed the drug.
The disclaimer
A lay summary should always be accompanied by a disclaimer, an important notice that informs readers of the summary's limitations to prevent them from misinterpreting the results. The notice should state that the results of one trial do not show the complete medical picture or represent the complete medical knowledge about a drug, and that patients should not change their current therapy on the strength of those results and should always consult their doctor before changing it. Sponsors should make clear in the notice that the summary describes only one clinical study, that readers should not change their therapy on its results, and that the safety data it describes are not the full picture of what researchers know. In one sponsor's lay summaries, the disclaimer, called “Important notice”, states that the summary presents only the results of a single study, that it cannot represent the entire knowledge about a drug and that other studies may have different results, and it alerts readers that they should not change their therapy on reading the summary and should always consult their physician.