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Author

Hope Cullen

Hope Cullen

Hope is director of project operations, Imperial Clinical Research Services. She has been with Imperial since 2007, and started as a project manager. In her current role, she leads a team of 11 project managers and coordinators to provide production, procurement, assembly, and logistics services for client study materials in support of global clinical trials. She also oversees client interaction, workload management, work processes and improvements, and revenue growth through customer service and relationship development efforts.

    Printing Clinical Trial Materials
    Clinical Trial Writing and DesignPatient EngagementSite Materials & Logistics

    Today’s Clinical Trials: Do Print Materials Still Pack a Punch?

    by Hope Cullen September 13, 2022
    written by Hope Cullen

    Even in this digital age, printed clinical trial materials remain popular and important tools for keeping sites and patients engaged. Clinical study sites rely on printed materials to gain local interest, and popular examples include:

    • Posters
    • Flyers
    • Brochures
    • Fact sheets

    These printed tools are designed to capture the attention of individuals passing through health care environments where the sites reside. These environments include independent research clinics and are often departments within a hospital or an academic medical center. These settings provide a broad-based opportunity to introduce the clinical study to many patients and health care professionals, allowing them to gain interest, start to digest the information, and ask immediate questions if needed.

    We often include QR codes on these documents. That way, a quick click on a smartphone will take a potential participant to the study’s online recruitment site to begin the recruitment process. This shows how printed and digital clinical trial materials work nicely together.

    Print is patient-centric

    In the U.S., internet use is high–close to 100 percent of adults are connected. Usage drops to 75 percent with the 65+ age group, which is the population usually needed for Alzheimer’s and dementia studies.

    Breakdown by age group

    https://www.statista.com/statistics/266587/percentage-of-internet-users-by-age-groups-in-the-us/

    About 10 percent of the world is 65 or older, and these mature populations often prefer non-tech options. In clinical trials, such a preference would clearly apply to recruitment and engagement materials like symptom diaries. Studies with older populations steadfastly rely on printed options.

     Participants appreciate print

    Print provides a personal connection. When our colleague Imogen Cheese interviewed study participants about their personal experiences, an oncology patient named Lucy told us firsthand about the power of printed clinical trial materials.

    Lucy described the contrast between joining a trial and later changing to an approved treatment:

    I was given verbal information, but I don’t remember being given any written information. I was quite shocked when I went to a different treatment. When I moved on to an approved treatment, I was given a glossy magazine about it, and I remember at the time going, wow, this is exciting, because I definitely didn’t get it with the first trial.”

    A quality printed piece has a tactile presence. It is a real object that allows the reader to connect physically as well as visually. A postcard, a brochure, or a flyer is a great take-home item that puts a clinical study right into the reader’s hands.

     Printed clinical trial materials can be the most reliable option

    Issues surrounding technical abilities and access are especially challenging for global clinical studies. According to the UN agency for digital technology, “2.9 billion people – around one-third of humanity – still remain totally offline, and many hundreds of millions more struggle with expensive, poor-quality access that does little to materially improve their lives.”

    For many studies, sponsors are concerned about the participant’s ability to use a technology solution.

    Areas of concern include:

    • Can the clinical study participant get what they need?
    • Does the participant have good connectivity?
    • Will they be able to find the information online?
    • Who will supply the device (site or participant)?
    • Is the participant’s device older? Is the operating system still supported?
    • Will the device be supported throughout the duration of the study?
    • Will the device’s power source function in the participant’s country?

    Printed clinical study materials can cut through all of that. Print is a known, workable way to share information and printed information can’t be hacked.

    In our blog about the future of decentralized clinical trials, Kenneth Getz listed some pitfalls of digital trials. Getz is an internationally-recognized expert on clinical trial management practices and trends.

    He pointed out that when using technology, dedicated personnel are required to train study staff members and patients on how to use the equipment and software and to troubleshoot technology issues. All this adds time and expenses to the trial.

    “There any many details we don’t typically think about,” he said. “There is a lot that has to be worked out and addressed.”

    A “thank you” goes a long way

    Clinical trial thank you card

    Simple tools can generate a strong impact. Every study should include thank you cards branded with the study name or protocol number. Amidst the blood draws, the ECGs, and exams, thank you cards reinforce the study team’s appreciation of the participant. Cards remind participants that they are more than data. Our clients use these at all different study phases, most often when study participation has ended.

    Another piece we create regularly is the milestone card. These are essential for long-duration studies. They can commemorate a year, or movement from one phase to another, such as from the blinded phase to the open-label phase.

    Printed greeting and thank you cards are timeless, and classic etiquette never goes out of style. In these days of cluttered inboxes, receiving a printed card is special.

    Printed clinical research materials can ease logistics

    Another consideration is logistics – when compared to technological tools, shipping paper is less challenging. The world is still facing monumental logistics challenges brought on by Covid, and now exacerbated by war in Europe, supply chain issues, and border tightening.

    Most countries are less concerned about paper products being imported than electronic goods, with software receiving particular scrutiny from customs authorities.

    Print remains a low-risk choice, and that’s what many sponsors and CROs like about it.

    Conclusion

    There’s no doubt that we are experiencing a growth of digital tools in clinical trials. However, there is no evidence of a pending shift completely from print to digital, and there is no substitute for the visual impact or tactile experience we get from printed materials. We doubt we will see the end of print anytime soon and expect printed clinical trial materials to remain a viable and robust option for a long time.

    September 13, 2022 1 comment
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  • Business InsightsPatient Recruitment and Retention

    Site Motivation: A Key to Study Success

    by Hope Cullen September 25, 2019
    by Hope Cullen September 25, 2019

    Motivating clinical research sites is one of the most overlooked factors in the pharmaceutical research industry. Even when sponsors and CROs do acknowledge the issue, they are often at a loss for workable solutions. This is precisely the reason Imperial offers site surveys, interviews, and…

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  • Ancillary Trial Supplies and EquipmentBusiness Insights

    You Don’t Know if You Don’t Ask

    by Hope Cullen July 17, 2018
    by Hope Cullen July 17, 2018

    Paper and pencil are so passé. Technology is being used in all types of studies to collect patient data in a myriad of ways. But even the simplest piece of technology is not without its challenges. Take the humble iPad, for example. Or, in this…

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  • Business InsightsLife-Science Events

    Surviving the Transition Into Clinical Trials: Getting Started

    by Hope Cullen April 5, 2018
    by Hope Cullen April 5, 2018

    We recently held the second of our presentation series “Surviving the Transition to Clinical Trials” at JLABS in Toronto. More than 45 people, representing biotech, pharma, and medical device companies, came to find out how to take their innovative ideas from the lab to the…

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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    7 Questions to Ask Your Ancillary Supplies Vendor

    by Hope Cullen June 26, 2017
    by Hope Cullen June 26, 2017

    It’s common for sponsors and CROs to work with vendors to acquire ancillary supplies and ship them to sites. From the outset, it is important to fully understand your vendor’s capabilities and range of services to make sure you can attain your goals. Asking the…

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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    Ordering Study Supplies? Do You Need to Consider the Sunshine Act?

    by Hope Cullen June 19, 2017
    by Hope Cullen June 19, 2017

      We have found that many studies neglect to have plans in place regarding the Sunshine Act. Don’t overlook this! Sunshine Act reporting is required in clinical studies, and it should be included in planning your activities to ensure reporting compliance. The Sunshine Act, specifically…

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  • Ancillary Trial Supplies and EquipmentSite Materials & LogisticsStudy Site ManagementTranslation of Study Materials

    7 Ancillary Supplies Adventures

    by Hope Cullen March 20, 2017
    by Hope Cullen March 20, 2017

    At Imperial, we know that selecting, procuring, and delivering ancillary supplies for clinical trials isn’t just loading syringes and Fitbits into FedEx boxes and sending them here and there. It’s as varied and challenging as you might imagine. Here are a few of my favorite…

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  • Site Materials & Logistics

    Reclaiming the Power of Paper for Clinical Trial Materials

    by Hope Cullen June 15, 2015
    by Hope Cullen June 15, 2015

    We live in a digital world.  Need directions? Use your phone app. Looking for your bank balance? Simply open your mobile banking app and log in. Want to read a book? Just download it! Paper printed materials are becoming a thing of the past. I’m…

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  • Business InsightsLife-Science Events

    An Evening with HBA’s Woman of the Year, Dr. Annalisa Jenkins

    by Hope Cullen September 22, 2014
    by Hope Cullen September 22, 2014

    On the evening of September 18, 2014, I attended the Healthcare Business Women’s Association’s (HBA’s) Woman of the Year event in Chicago and had the pleasure of meeting Dr. Annalisa Jenkins, CEO of Dimension Therapeutics. Every year, the HBA elects one woman as the HBA…

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  • Business Insights

    See Do Get

    by Hope Cullen August 12, 2014
    by Hope Cullen August 12, 2014

    A simple strategy for effective organizational leadership In Stephen Covey’s book First Things First the author asserts that, “If we want to create significant change in the results, we can’t just change attitudes and behaviors, methods or techniques; we have to change the basic paradigms…

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