Imperial Wins International Creative Awards. Learn More

Imperial Clinical Research Services Blog
  • Services
    • Study and Site Print Materials
    • Clinical Trial Translation Management
    • Ancillary Trial Supplies and Equipment
    • Clinical Trial Patient Engagement
    • CRO-Centered Services
    • A La Carte Services
  • Resources
    • Blog
    • Ebooks
    • Case Studies
  • About
    • News
    • Corporate Responsibility
  • Contact
    • Career Opportunities
    • Contact Imperial
  • Blog
  • Marketplace
  • Services
    • Study and Site Print Materials
    • Clinical Trial Translation Management
    • Ancillary Trial Supplies and Equipment
    • Clinical Trial Patient Engagement
    • CRO-Centered Services
    • A La Carte Services
  • Resources
    • Blog
    • Ebooks
    • Case Studies
  • About
    • News
    • Corporate Responsibility
  • Contact
    • Career Opportunities
    • Contact Imperial
  • Blog
  • Marketplace
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.

    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
    1 FacebookTwitterLinkedinEmail
  • 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…

    0 FacebookTwitterLinkedinEmail
  • 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…

    2 FacebookTwitterLinkedinEmail
  • 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…

    1 FacebookTwitterLinkedinEmail
  • 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…

    0 FacebookTwitterLinkedinEmail
  • 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…

    1 FacebookTwitterLinkedinEmail
  • 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.…

    1 FacebookTwitterLinkedinEmail
  • 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…

    0 FacebookTwitterLinkedinEmail
  • 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.

    1 FacebookTwitterLinkedinEmail
  • Life-Science Events

    DPHARM Conference Hits Year 11: Driven by COVID, it Delivers its Proof of Concept

    by Dan McDonald October 5, 2021
    by Dan McDonald October 5, 2021

    Like many conferences in the COVID era, DPHARM, the annual conference based in Boston and focused on disruptive innovations in clinical trials, moved from in-person to a virtual setting this week, due to local spikes of the Delta variant. To date, I’ve largely avoided these…

    1 FacebookTwitterLinkedinEmail
  • 1
  • 2
  • 3
  • 4

Welcome

Welcome

The Imperial blog features content of interest to life-science professionals, with a special focus on clinical trials. We hope you will enjoy our experts’ perspectives, and invite you to join the conversation by leaving your comments. Please let us know of any additional topics you would like to see covered here.

Keep in touch

Twitter Linkedin Youtube Email RSS

Popular Posts

  • 1

    Google Translate: The Unwitting Confidentiality Flaw

    April 15, 2020
  • 2

    25 Reasons People Aren’t Enrolling in Your Clinical Trial

    October 29, 2015
  • 3

    See Do Get

    August 12, 2014
  • 4

    Clinical Trial Supply Chains: The Key to Avoiding Disruptions

    May 10, 2022
  • 5

    COVID-19 Brings Pressure Testing to Ancillary Supplies and Equipment

    May 4, 2021

Categories

  • Ancillary Trial Supplies and Equipment (13)
  • Business Insights (99)
  • Clinical Trial Writing and Design (19)
  • Life-Science Events (42)
  • Patient Engagement (13)
  • Patient Recruitment and Retention (73)
  • Site Materials & Logistics (28)
  • Study Site Management (17)
  • Translation of Study Materials (15)
  • Uncategorized (1)
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.

Imperial CRS Corporate Headquarters
3100 Walkent Drive NW
Grand Rapids, MI 49544

Contact

connect@imperialcrs.com

800.777.2591

020 3887 3437

Employment

Social

© Imperial CRS, Inc. | Privacy Policy