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Developing High-Quality Printed Materials for Clinical Trials

by Hope Cullen

There are three major categories of printed materials supporting clinical trials: 1) Recruitment and Retention Tools, 2) Data Collection Tools and 3) Site Reference Tools.

Why differentiate? Because the intended use of the tools, the time, money and quality put into the development and print of the materials can vary dramatically.

1. Recruitment and Retention Tools: These materials are generally patient-facing and are akin to marketing materials. They are intended to encourage the patient to participate in the study and remain a participant throughout the entire visit cycle. Investment in development can and should be given significant consideration.  A qualified medical writer can tailor the content to the appropriate audience, and a graphic designer with both creativity and an understanding of print production can prepare materials that maximize their print value. Generally these materials have a “brand” or “look” that patients can associate with the trial. Not all designs or layouts print well, so selecting a graphic designer who can create a unique look and select designs that will print well, is key to making these materials effective.

2. Data Collection Tools: These materials are critical to study success but do not necessarily require a “brand.” For these materials, the design is more important for effective functionality than for aesthetic or recruitment value. Forms designers have experience in setting these tools to be easy to understand, straightforward to complete, and effective for data capture and/or transfer to an electronic system. Prior to EDC, data collection forms with multiple write-thru pages were the norm. In today’s increasingly technology driven world, printed data collection tools are single part forms, since much of the information gets transferred to an electronic system.  In either case, the best way to maximize the utility of data collection forms is to have them designed for ease of use for the investigator and/or patient to complete. Many trials require multiple assessments during different visits, so it is important that the form is designed well, and that the printed construction is designed effectively.  Many times a booklet with all the data collection forms for a single visit, for a single patient works well. Other trials utilize a binder for individual patients, and separate visits by tab dividers. No matter what the trial requires, data collection forms can be designed and constructed to be completed effectively.

3. Site Reference Tools: These are often compliance driven, or regulatory documents that the site needs to conduct the study. Unlike recruitment tools, no marketing elements are needed, and unlike data collection tools, design and construction for ease of use is not typically a significant requirement. These materials generally receive the least amount of preparation with regards to design and print. Study team members with many responsibilities and areas of focus are often still tasked with developing, preparing and organizing these materials for print. That can be okay, since the content is the most critical element of reference materials. However, since these material files are not often prepared by professionals, the print quality can suffer. When preparing regulatory or reference materials, a few tips can go a long way to ensuring the highest quality of production.

  • Do not use scanned images. Scanned images are inherently low resolution and will print poorly.
  • When using company logos or other  photos/images, ensure they are high resolution.
  • Use fonts that are readily available or embedded into the files you create.

When in doubt, your print vendor can assist so that you can get the best production quality for these materials. They can educate, advise and often manipulate the files so the quality is improved for the end product.

All materials supporting a clinical trial have significance, but not all materials are weighted equally. To get the best quality print for the best value, weigh the return on investment of professional involvement and the item’s intended use. Looking at these attributes will help to ensure material budget is effectively leveraged to meet trial objectives.

 

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