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Category:

Patient Engagement

    Clinical trial enrollment timelines
    Patient EngagementPatient Recruitment and RetentionStudy Site Management

    Clinical Trial Enrollment Timelines: Hidden Causes Behind Big Delays

    by Dan McDonald December 22, 2022
    written by Dan McDonald

    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 chances your study will be a success. It’s not a magic trick, it’s just statistics.

    First Patient In (FPI) is a key indicator of the overall success of a study. If that first patient is enrolled on time or within 30 days of the FPI goal, your study will begin on sound footing. The further you miss that goal, the more success will elude you. Here are the statistics:

    clinical trial enrollment

    Getting that first patient into the study on time is critical. If that goal isn’t met, it takes longer to gain traction and raises the likelihood that you will not hit your clinical trial enrollment targets. Your study will not meet its timelines.

    This makes strategic patient recruitment an important tool in meeting FPI and LPFV (Last Patient/First Visit) goals.

    In the past, about 70 percent of our business consisted of rescue programs for low-enrolling studies. We have seen considerable progress in this area: more than 70 percent of the studies we support today have proactive recruitment programs.

    Sponsors have grown more sophisticated with recruitment, and many have even created internal departments tasked with accelerating enrollment. Merck’s Global Trial Optimization team is a noteworthy example.

    Nevertheless, there is still room for improvement. A survey conducted by Imperial a few years ago revealed that 45 percent of line managers at sponsor companies had no proactive recruitment plans but also lacked the authority to put plans in place. Unfortunately, they are setting themselves up for delays.

    Bring in the sites as a clinical trial enrollment strategy

    Sites are the front lines of research and enrollment. Maximizing communication with sites early and often will help boost their performance.

    Sites have tremendous insights and expertise that can be tapped. Here are tips on maximizing site performance:

    • Capture site buy-in early and often
    • Site support is a must-have topic at investigator meetings and training
    • Involve clinical research coordinators in the planning and execution
    • Arm sites with tools (75 percent of sites utilize patient recruitment materials)
    • Show sites that you care and you are investing in their success and want their input
    • Minimize the lag time between site feasibility, investigator meeting, and study initiation

    Communicate on a fixed schedule

    We find sites are vocal – and helpful — when asked for their perspective and input. We recommend forming site steering committees. These committees are made up of coordinators from top-performing sites and also mid and low-performing sites. Meet monthly or every six weeks to share recruitment and retention best practices as well as challenges.

    And always remember that you are often competing with other sponsors’ studies for the site’s efforts and attention. Spending time with site staff and applying the tips I’ve mentioned to demonstrate your commitment can differentiate you from other sponsors and go a long way in motivating them to be enthusiastic about your study and clinical study enrollment goals.

    Getting clinical trial enrollment right and getting it wrong

    Studies that routinely meet FPI and LPFV timelines employ these planning strategies:

    • Recruitment planning starts with protocol design
    • Budgets are realistic
    • Plans are revisited often
    • Country startup planning ensures that the slowest locations are not activated last
    • Outside voices (partner/recruitment vendor) are often utilized
    • A multifaceted strategy is employed to meet study goals, including such tools as:
      • Physician referral programs
      • Community outreach
      • Advocacy groups

    By contrast, here are common practices that will seal the fate of any study (yes, this really does happen):

    • Not being competitive (lowballing contracts and grants)
    • Paying sites late
    • Falling into the key opinion leader trap (placing too much faith in “experts” or using the wrong experts)
    • Failing to plan for backup sites to be activated if necessary
    • Fixating on the latest single silver bullet, shiny ball approach
    • Waiting too long to ask for help

    Summary

    Effective recruitment strategies, utilizing site expertise, and keeping a sharp focus on proactive planning are the heart of meeting clinical trial enrollment timelines and reaching study success.

    Imperial is here to help. Optimize your clinical trial recruitment and retention plans with our evidence-based patient recommendations. Imperial’s diverse therapeutic knowledge and 25+ years of research patient engagement experience position us to collaborate with you on any indication and patient population. Our subject matter experts are here to help — contact us!

    In my next post in this series, I will write about hidden delays in patient retention and compliance.

     

     

     

     

    December 22, 2022 1 comment
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  • Clinical Trial Writing and DesignPatient EngagementPatient Recruitment and RetentionSite Materials & Logistics

    Printed Clinical Trial Materials: Planning for Investigator Meetings & Study Startup

    by Kirsten Friend December 12, 2022
    by Kirsten Friend December 12, 2022

    When planning to launch a new clinical study, many decisions are needed. Some of those decisions surround clinical trial materials planning as part of patient recruitment and retention plans, and site study reference and referral tools. Once the plans are in place, they are often…

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  • Business InsightsLife-Science EventsPatient EngagementPatient Recruitment and Retention

    Summit Reveals Clinical Trial Challenges and Solutions

    by Imogen Cheese December 1, 2022
    by Imogen Cheese December 1, 2022

    My colleague Frances Bentley and I had the privilege of attending the 8th Annual Clinical Monitoring and Patient Recruitment Retention (CMPRR) Summit in Barcelona. Several clinical trial challenges and solutions were discussed. I was there to present a talk titled “Exploring the Hidden Challenges to…

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  • 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
    by Hope Cullen September 13, 2022

    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…

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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 Retention

    Decentralized Clinical Studies: What Does the Future Look Like?

    by Kirsten Friend August 8, 2022
    by Kirsten Friend August 8, 2022

    Clinical trials have existed for centuries, shaped by brilliant minds, historical events, and medical crises. When COVID emerged, many research sites closed or patients stayed away as non-COVID trials paused. Decentralized clinical studies experienced a metamorphosis, putting into action what had previously been primarily ideas.…

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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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  • Patient EngagementPatient Recruitment and Retention

    Trial Challenges: Overcoming Objections to Study Placebo Use

    by Imogen Cheese June 14, 2022
    by Imogen Cheese June 14, 2022

    I was asked to give my perspective on placebo-controlled trials. Using a study placebo presents challenges in recruitment and retention, especially because participants tend to hope that joining a study will lead to a positive treatment response. As I have mentioned in quite a few…

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  • Patient EngagementPatient Recruitment and Retention

    Clinical Trial Participants Sound Off

    by Imogen Cheese April 26, 2022
    by Imogen Cheese April 26, 2022

    My colleagues and I attend several international conferences every year. We are particularly interested in discussions surrounding clinical trial participants and patient engagement, as this is an area where Imperial is involved with support for our sponsor and CRO clients. It’s reassuring to see and…

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