User Tests for Clinical Documents

From documents to clinical trials: lay summaries, educational materials, patient information, diaries, and questionnaires.

High readability and clear messaging are very important for medical and pharmaceutical documents. They provide a crucial foundation for the safe and effective use of your product, build trust in your product, and minimize the risk of misuse and other hazards associated with its use.

Lay summaries of clinical trial results are easy-to-understand descriptions of the design and overall results of clinical trials. The EMA initiated the requirement to submit lay summaries through the EU Clinical Trials Regulation (EU CTR) No. 536/2014. In addition to other elements described in the regulation, sponsors must submit a summary of the clinical trial results, regardless of the trial’s outcome. The summary must be provided in a “layperson-friendly format” and, for studies involving adults, uploaded to the portal one year after the end of the trial (EoT), and for studies involving the pediatric population, six months after the EoT, in all EU languages in which the study was conducted.

Information for physicians or patients must often be provided as part of marketing authorization requirements in the form of training materials. The challenge here is to present important information—such as instructions for use—in a concise, clear, and understandable manner. Ultimately, a user test reveals whether these complex materials actually make the physicians’ jobs easier or provide helpful guidance for patients.

The same applies to patient documents in clinical trials. Clear and understandable documents ensure that study participants feel well-informed. This makes it easier for participants to understand the study protocol, helping them to participate with motivation and actively contribute to the study. As a result, optimal data collection and the highest possible data analyzability are ensured.

Using User Test and drawing on the validated readability test for package inserts, we assess whether your medical documents and data are clear and understandable to your target audience. Naturally, our many years of experience with clinical trials and our expertise in handling medical and pharmaceutical texts and design are incorporated into the development and optimization of your documents, helping to ensure they meet your desired requirements.

Thanks to our extensive pool of test subjects and our collaboration with a wide variety of patient support groups, we are also able to conduct testing with specific target groups.

Timing—always possible: from product/study development through post-marketing

We'd be happy to test the following for you:

• Patient Support/Compliance Programs (PSP), including apps, software, and websites

DOCUMENTS FOR CLINICAL TRIALS:

• Summary of Clinical Trial Results for the General Public (Lay Summary)

• Study descriptions, patient information for clinical trials (Patient Information Sheets (PIS))

• Informed Consent Forms (ICF) for Clinical Trials

• Patient Diaries

• Surveys used to collect patient assessments, such as those regarding quality of life, perceived symptoms, and patient satisfaction (Patient-Reported Outcomes (PRO))

MEDICAL DOCUMENTS:

• Training materials for healthcare professionals (counseling materials, therapy guides, product preparation instructions)

• Patient education materials (handouts for educational programs, e.g., high blood pressure education)

• Patient Information Materials (information brochures, guides, checklists)