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Author

Dan McDonald

Dan McDonald

Dan is vice president, business development, Imperial Clinical Research Services. Dan is a seasoned executive who specializes in identifying income opportunities, building strategic partnerships, and managing contract negotiations. A prolific and popular thought leader, Dan has presented at numerous industry conferences and events, has conducted workshops and sessions on patient engagement, and has been published numerous times in industry books, trade magazines, and journals.

    Patient EngagementPatient Recruitment and Retention

    Hidden Causes of Clinical Trial Retention and Compliance Issues

    by Dan McDonald April 11, 2023
    written by Dan McDonald

    This is the last in my three-part series revealing hidden causes behind delays in clinical studies. Part one is here, and part two is here. This final installment explores clinical trial retention and compliance.

    Are you waiting too long to begin planning patient retention and compliance in your trial? We often say that retention starts with recruitment. How you recruit–more specifically, how and what you communicate and how you educate during the recruitment period–will directly impact your retention results.

    Successful clinical trial retention and compliance are directly affected by the decisions you make very early–during the planning phase, while the protocol is still being drafted. It is critical to weigh the data desired against the patient burden right from the start.

    Carefully consider these key participant concerns while planning your trial:

    • Number of visits
    • Frequency of visits
    • Length of visits
    • Procedures and their frequency
    • Education and justification to the participant so they understand why lengthy and/or painful procedures are necessary and vital for the research
    • Support available from additional individuals in the patient’s life
    • Impact of the study on the participant’s home and work life
    • Impact of the study on the participant’s loved ones

    Understanding patient needs is an essential first step. While site personnel who run day-to-day practices for the target condition will be able to shed some light on the patient experience, you may have to go further. Hosting patient panels and conducting surveys of the target population can yield useful findings on what patients need so they will consent to participate and remain in the study on an ongoing basis.

    Expectations: make them realistic

    Once you begin recruiting and promoting your trial, fully educating potential study subjects is paramount. Let them know exactly what to expect by fully discussing the points in the list above. Even though this information is routinely covered during informed consent, patients sometimes underestimate the commitment, and once enrolled, their motivation to continue wanes.

    Clinical trial retention

    Retention is a constant effort, and even the most committed participants will benefit from retention tools to keep them motivated. These tools range from simple to more complex and commonly include:

    • Patient panels and focus groups to review and comment on study details surrounding their involvement
    • Comfort and activity items—a world of options are available. Examples of items Imperial has sourced for our clients and their patient volunteers include blankets, insulated bottles, cooler bags, slippers, note pads, tote bags, hygiene kits, and many more. While small in cost, these items go a long way to show your study volunteers that you care, that you’re aware of the challenges of trial participation, and that you’re listening.
    • Communication with participants through:
      • Patient newsletters
      • Technology, such as appointment reminders sent via text and study apps with study information
    • Appointment reminder cards
    • At-home study visits as an option (I say an option because many participants will tell you they prefer visits at the study site)
    • Meal provision during extended study visits
    • Reimbursement to cover travel costs for attending study visits

    Keeping study participants informed, letting them know they are appreciated, and reducing cost burdens improve the participant’s willingness to stick with the clinical study.

    Additional considerations for clinical study retention

    Remember to budget for retention. More clinical operations professionals are building recruitment budgets, but retention is often not included. Consider allocating about 5 percent of your site per patient grants for retention strategies. Setting aside budget dollars now and putting centralized strategies in place will help avert costly challenges down the road. Remember to measure progress along the way and be prepared to adapt as needed. Clinical trials are living, breathing things and rarely go exactly how you planned.

    And, of course–never pass up an opportunity to THANK your study volunteers.

    Imperial Advantage

    Even the most carefully planned and executed trial will face challenges. Imperial is ready to step in at any time to help, from study startup to all points following, including recruitment, retention, and closeout.

    What are some of the most significant challenges you’ve faced with clinical trial recruitment and retention? How did you overcome those challenges? Scroll down and add your comments in the comment box below.

     

    April 11, 2023 0 comment
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  • Patient EngagementPatient Recruitment and RetentionStudy Site Management

    Clinical Trial Enrollment Timelines: Hidden Causes Behind Big Delays

    by Dan McDonald December 22, 2022
    by Dan McDonald December 22, 2022

    This is the second in my three-part series revealing hidden causes behind delays in clinical studies. The first part is here. This installment explores strategies to meet clinical trial enrollment goals. Tell me when your first patient was enrolled, and I will tell you the…

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  • Patient Recruitment and RetentionSite Materials & Logistics

    5 Reasons Print for Clinical Studies is a Powerful Tool

    by Dan McDonald October 27, 2022
    by Dan McDonald October 27, 2022

    Imperial began as a business printer and evolved and broadened over four decades to fully support clinical studies in a million different ways. Today, printed materials are still popular. In our U.S. and U.K. facilities, our presses keep rolling, as the sponsors and CROs we…

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  • Patient Recruitment and RetentionSite Materials & Logistics

    Clinical Study Startup and Execution: Hidden Causes Behind Big Delays

    by Dan McDonald October 21, 2022
    by Dan McDonald October 21, 2022

    Before you plan your next study, please read this first. Planning and conducting a clinical trial presents numerous challenges, and we find that many sponsors and CROs repeatedly miss important areas when planning their studies. These planning gaps result in: Delayed clinical study startup Missing…

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  • Ancillary Trial Supplies and EquipmentClinical Trial Writing and DesignPatient EngagementPatient Recruitment and RetentionSite Materials & LogisticsTranslation of Study Materials

    Clinical Trial Efficiencies: The Power of a Single Workstream

    by Dan McDonald August 18, 2022
    by Dan McDonald August 18, 2022

    The management time needed to corral many different elements during a trial is immense. In the buildup to a research study, clinical operations teams often focus on items such as study startup, site initiation and activation, supply chain, monitoring, data management, and safety. And there…

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  • Business InsightsPatient EngagementPatient Recruitment and RetentionUncategorized

    DIA Takes on Technology in Clinical Trials

    by Dan McDonald June 23, 2022
    by Dan McDonald June 23, 2022

    An interesting element of every DIA annual meeting is the variety of voices that are brought together from across the drug development ecosphere. From industry to regulatory bodies, academia, and even students, diverse backgrounds and experiences are brought to the table. The cumulative effect is…

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  • Business InsightsLife-Science EventsPatient Engagement

    Opening Day at DIA Meeting: Two Clinical Trial Approaches Join Forces

    by Dan McDonald June 21, 2022
    by Dan McDonald June 21, 2022

    Hello from the 2022 DIA Global Annual Meeting. Not surprisingly, decentralized clinical trial approaches has the spotlight here. This includes: Wearables and sensors for remote data collection Mobile screening units Home trial visits Also in the spotlight at the DIA meeting is the rise of…

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  • Business InsightsLife-Science EventsPatient Recruitment and Retention

    OCT East: Industry Agility and Decentralized Clinical Trials

    by Dan McDonald June 1, 2022
    by Dan McDonald June 1, 2022

    Sponsors, CROs, and vendors gathered in person at the Outsourcing in Clinical Trials (OCT) East Coast Summit in King of Prussia, Pennsylvania, over two days in May. Speakers discussed the journey of recent years and shared predictions of what the future holds for new strategies.…

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  • Life-Science Events

    Diversity Takes Center Stage at SCOPE 22

    by Dan McDonald March 1, 2022
    by Dan McDonald March 1, 2022

    Diversity in clinical trial participation emerged as one of the most important and impassioned topics presented and discussed during the SCOPE 22 Summit in Orlando, Florida. Covid, and its wide-ranging impact, served to reveal how different groups were differently affected, and it shed light on…

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  • Life-Science Events

    OECT-Canada Virtual Conference Not as Remote as Expected

    by Dan McDonald November 2, 2021
    by Dan McDonald November 2, 2021

    I have come to cherish the opportunity to gather with a select group of industry experts across geographic borders and company types to discuss the pressing issues of the day impacting clinical research. Being smaller events, with many panel sessions and working groups, it’s hard for anyone attending to not be pulled into the discussion.

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Imperial Clinical Research Services Blog

Imperial CRS is a global leader in clinical trial solutions and support, specializing in study and site print materials, ancillary trial supplies and equipment, clinical trial translation management, and clinical trial patient engagement.

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