Patient Recruitment with Kunal Sampat

In this episode, I share with you strategies and tactical advice on patient recruitment.

Patient recruitment is the foundation of any clinical study.

If your trial doesn’t enroll the minimum number of patients required per protocol, you or your company cannot get the data you need to prove your trial hypothesis, determine product safety and effectiveness.

More importantly, you cannot bring the medical product to the market on time (or possibly never!). This means loss of revenue and profits for the sponsor but more importantly, the patients that need your therapy won’t get it.

In this podcast, I’m going to share with you 4 amazing strategies that will help you with patient recruitment.

If you’re directly involved in a clinical study as a sponsor, CRO or even a site, this episode is a must-listen. If you’re creating a product or service for clinical research professionals, you need to ensure your work ultimately supports patient recruitment.

Hope you enjoy listening to this solo episode by yours truly.

Show Notes:

Four Patient Recruitment Challenges

  1. PI/RC have competing priorities
  2. Protocol I/E is too challenging
  3. The site does not have the tools/ support needed to be successful
  4. The site has no enrollment or is underperforming

Strategy 1: Help Sites Address Competing Priorities

  1. Set expectations during the site initiation visit (SIV)
  2. Get them excited when the site is activated for enrollment
    1. How will you support the site
    2. Who will support the site (name and phone number)
    3. What happens if they cannot enroll
    4. Screening Log requirements
  3. Create an Enrollment Action Plan
  4. Find opportunities to have at least two dedicated conversations about enrollment with RC and PI

Strategy 2: Design A Recruitment Friendly Protocol

  1. The schedule calls between medical science and site to understand inclusion/exclusion challenges and patient recruitment workflow
  2. Batch your site feedback into one protocol amendment
  3. Get input from the study PI
  4. Use data from the screen failure logs to drive your decisions

Strategy 3: Provide Sites with Tools and Support

  1. Schedule mini investigator meetings at local congresses
  2. Create enrollment tools such as pocket cards, posters, etc.
    1. Translate them as necessary
    2. Get a graphics designer to help you
    3. Print in small batches
  3. Send congratulation emails to the site PI, RC, sub-Is after FPI, CC study PI
  4. Conduct quarterly webcasts
  5. Send out quarterly newsletters
  6. Weekly enrollment newsletters

Strategy 4: Proactively Manage Underperforming Sites

  1. Set a due date for close sites with 0 enrollment. Don’t waste your resources on sites that will never enroll
  2. Contact sites that have not enrolled a patient in recent weeks

Summary

  1. Help Sites Address Competing Priorities
  2. Design A Recruitment Friendly Protocol
  3. Provide Sites with Tools and Support
  4. Proactively Manage Underperforming Sites

What enrollment strategy have you had success with? What has worked for you in the past?

Let me know in the comments sections below.

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