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Category:

Study Site Management

    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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  • 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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  • Patient Recruitment and RetentionStudy Site Management

    Cultivating Site Partnerships for Maximum Recruitment Success

    by Diana Foster October 13, 2015
    by Diana Foster October 13, 2015

    There is a lot of emphasis today on the relationship between sites, sponsors and their CRO partners. Site sustainability and strong partnerships that help cultivate the success of clinical research sites is of critical importance to the conduct of trials. With enrollment success at the…

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  • Business InsightsStudy Site Management

    End of Study Tasks – Going Beyond the Checklist

    by Ted Corrigan January 20, 2015
    by Ted Corrigan January 20, 2015

    How exciting, it’s finally time to close the Study! Not so exciting – the task list and documentation required to get things in order. Many of our customers have CRA’s or other personnel who are responsible for ‘End of Study’ (EOS) tasks when closing out…

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  • Patient Recruitment and RetentionStudy Site Management

    Podcast Episode #04: Big Data Comes to Fruition

    by Dan McDonald December 11, 2014
    by Dan McDonald December 11, 2014

    – Data-Driven Approaches to Streamlining Study Planning Processes – Perspectives of big data have done a complete 180 in the last 10 years. Sponsors and CRO’s are seeking to lessen cycle times while simultaneously managing more complex protocols, and they’re seeking new answers. As data-driven…

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  • Business InsightsSite Materials & LogisticsStudy Site Management

    Outsourcing Partnerships: Factors You Need to Consider

    by Ted Corrigan December 5, 2014
    by Ted Corrigan December 5, 2014

    There are few examples of truly innovative outsourcing partnerships in the life sciences. These partnerships bring together two or more companies in a structurally integrated manner to yield untapped efficiencies. The most innovative of partners completely rewrite the course of each business, for the better…

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  • Site Materials & LogisticsStudy Site Management

    Tried & True Principles for Global Site Selection

    by Dan McDonald October 30, 2014
    by Dan McDonald October 30, 2014

    The drug development industry has seen a seismic shift in the past decade with regards to how investigative sites are identified and selected for clinical trials. Like many other aspects of our industry, site selection is benefitting from technology and a rapidly expanding pool of…

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  • Business InsightsStudy Site Management

    Big News for Small Sites Seeking Research Grants, Part II

    by Stephanie Burns September 15, 2014
    by Stephanie Burns September 15, 2014

    – A Q&A on Government Research Grants – In the first segment of this two-part blog series, we heard from Johnna Medina (University of Texas, Austin), a fourth-year clinical psychology doctoral student, on her views and thoughts about clinical research at the university level and the…

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  • Business InsightsStudy Site Management

    Big News for Small Sites Seeking Research Grants

    by Stephanie Burns August 6, 2014
    by Stephanie Burns August 6, 2014

    A Q&A with Johnna Medina, a clinical psychology doctoral student at the University of Texas, regarding government-funded research grants. Part I of II Who pays for clinical research? Nearly 75% of clinical trials are paid for by private companies, but where does the rest of…

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  • Business InsightsPatient Recruitment and RetentionStudy Site Management

    Only the Lean and Limber Need Apply

    by Melynda Geurts June 27, 2014
    by Melynda Geurts June 27, 2014

    Adaptive Clinical Trials: 6 Traits to Look for in a Vendor Adaptive is a word that has graced the life science industry for decades. By definition adaptive is showing or having a capacity for or tendency toward adaptation. Advancement of science through clinical trials is…

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