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Recruitment Powered By Docstoc
					                    Recruitment for
                     Clinical Trials
                      Yvonne Kellar-Guenther

This training is part of the Clinical Trials Training for Investigators and
Coordinators (CTTIC) (PI, Yvonne Kellar-Guenther, Ph.D.). The CTTIC is
part of the Colorado Clinical Translational Sciences Institute (CCTSI)
grant. This grant was awarded to the University of Colorado Denver by
National Institutes of Health, Principle Investigator is Ronald Sokol, MD.
Course Objective
   Understand:
       The importance of Recruitment
       The terminology used
   Overview of Recruitment Process
   Things To Think About Before
   Where To Start
   How To Create To An Ad
   Regulatory Issues
   Retention Ideas
Why Focus On Recruitment?
   “Recruitment of eligible participants is one of
    the most important activities in a clinical trial”.
    (1999, Cosgrove et al.)
   Resources necessary for effective
    recruitment in clinical trials are often under-
    estimated (Bjornson-Benson et al., 1993).
   Recruitment is one of the hardest parts of
    conducting a clinical trial.
Recruitment Process
Recruitment Process
   Identify Who You’ll Target
   Identify How You’ll Find Participants
       You find them
       They find you
   Identify What You’ll Say
   Identify If You’ll Give Them Something And If
    So, What
   Identify What You’ll Say To Them
   Come up with a study idea as a class
Determining Who You
          Will Target
Define Target Group
   Read And Learn The Study Protocol
   Study The Inclusion And Exclusion Criteria
       Specific inclusion criteria and extensive exclusion
        criteria can make the target group smaller
       Don’t use recruitment strategies for the general
        public if you have a lot of inclusion/exclusion

    Tip: Remember part of the intake/recruitment
      process is to take make sure the person meets
      the inclusion/exclusion criteria. Do you need a
      medical history? Special test?
Decide if Will Have Incentives
   Not All Studies Have Incentives
   Could Be Payment Or Goods (T-shirts, Water
    Bottles, Magnets, Diapers)
   Reimburse For Travel and/or Parking
   Provide Travel (e.g. Transportation Van)
   Double-edged Sword (Stanford et al., 2003)
       Can increase response rate but may threaten
        retention rate
           Might join study, get fee and then leave
   Finding Your

You contact them
Use Existing Database to Get
Contact Information
 Driver’s License Lists (DMV)
 Voter Registration Lists

 List from Sponsor

 Private List (medical or service provider)

 Patient List

 Disease Registry

 List From A Previous Study Where The Individual
  Said You Could Contact Them For Future Studies
Think about how get an updated list
      TIP: Think about who you want. Will the list you are getting help?
      People who have low income may not have a car or register to vote.
      Younger adults may not register to vote. Find the list that fits your
Existing Study/Practice Patients
   Database Of Existing Study Patients
    Practice Patients
   Referrals - From Medical Practices, And
    Study Patients
       Tip: If these aren’t your patients, remember to use
        a HIPAA A form.
   How contact them for our study idea?
   Our IRB Needs You To Say Why More Than
    3 Attempts
       If you need to make more, you need to justify it in
        your COMIRB application
   Finding Your

They contact you
Adverting Approval
   21 CFR Part 50 Subpart B Informed Consent
    Of Human Subjects
   Direct Advertising And Recruiting Are
    Considered The Start Of The Informed
    Consent Form Process
Contact Approaches – How Will
You Get the Message Out
   Media Campaigns (including Public Service
       Fliers
       Radio spots
       Television spots
       Newspaper advertisements
       Posters
       Electronic message boards
       Facebook/electronic social networks
       Classifieds – paper and on-line
Contact Approaches – How Will
You Get the Message Out
   Paper Publications
       Coupon shopper and advertising magazines
       Magazines
       Direct mail
       Patient Education Programs
       Dear Doctor letters
Contact Approaches – How Will
You Get the Message Out
   Electronic Postings
       Electronic message boards
       Social Network site (e.g. Facebook)
   Issues to Think Through
       Is this a group that has access to the internet?
       Is this a group that would use electronic sites?
Contact Approaches – How Will
You Get the Message Out
   Inpatient Recruitment
       Form relationships with nursing staff
       Have research staff talk to patients
       Fliers
           In admission packet
           Posted on the floor
   Before You Start Look at Successful Advertisements
    In The Newspaper, Magazines And TV.

   Discuss General Advertising Approaches With
    Marketing Sales Drug Representatives For Ideas
    And Suggestions.
Free Pictures for non-
commercial use
   Be Creative
   Think BIG
   Promote The Positive Features Of The
   Try A Theme Approach
   Try To Position The Ad In A Special
   Use Pictures Of Group You are Targeting
    (e.g. children for pediatric ads)
   Multiple Methods to Contact Potential Participants
       More costly
       Reach more people
   Multiple Times
      Same ad done over and over
   Have A Designated Phone Number People Can Call
    – Including Voice Mail
       Need to have staff to answer phone or retrieve messages
Create Recruitment
For Electronic or Printed
   All Advertising Materials And Methods Must
    Be Approved By The IRB
   The Principal Investigator Is Responsible For
    All Advertising Even If Disallowed Language
    Is Approved By The IRB
Ways to Define Your Recruitment
   What Is The Goal Of The Study?
   What Motivates A Patient To
    Participate In Your Clinical Trial?
   What Does The Patient Know?
   What Does The Patient Want?
   What Does The Patient Need?
   What Does The Patient Expect?
   What Does The Patient Understand?
Advertising Language – What you
Can Say
   Limited To IRB Approved Words Or Phrases
       Study related medication
       Study related testing
       Study related doctor visits
       Qualified participants will receive financial
       Study may improve the quality of your life
All Written Recruitment Materials

   Must Have
       PI
       IRB Number
       Contact person and phone number
       The phrase “investigational”
       The name of the Institution(s)
Example – Wiley Protocol –
What is Wrong?
Imitating Nature, Naturally.
You no longer need to debate hormone replacement therapy. If you are one of
   more than 47 million women experiencing discomfort from menstruation to
   menopause, or loss of libido, the Wiley Protocol® may be your answer.

Biomimetic – a true bio-identical. WP uses the rhythm of nature to establish the proper doses of
    estradiol and progesterone to mimic the natural hormones produced by your body. It is a more accurate form of
    hormone restoration. Hormones can be called bio-identical only when they are dosed in a biomimetic fashion.

Derived from plant sources they mimic the natural wavelike, rhythms of the
   hormone blood levels in a normal menstrual cycle. It is this natural rhythm that
   is missing from all other hormone replacement therapies.
    The world as we know it, the entire universe, in fact from bacteria to blue whales, is all about timing. Individual
    rhythms deep within us overlap into larger patterns outside of us -- which then weave in and out of each other.

The Wiley Protocol relieves the discomforts of
  menstruation, menopause and hormone imbalances.
  Tens of thousands of women use it and love it.
Advertising Restrictions – What
You Can’t Say
   Cannot Promote Investigational Products Or
   Can Not Promise That A New Drug Is Safe Or
   Cannot List Amount Of Payment. Instead Say “Will
    Be Compensated For Qualified Participation”.
   Compensation Wording Cannot Be Bold Or
    Larger Than The Rest Of The Ad.
   Pictures In The Ad Cannot Be Inappropriate Or
Advertising Restrictions – What
You Can’t Say
   Words And Phrases Disallowed
       New treatment
       New medication
       New drug
       Free
       Promising greatness
       Misleading language or coercive
       Altruistic phrases (e.g. “help others like you”)
   What Is Wrong With The Ad?
   What Would Make It Better?
   Who Is Your Target?
   Where Would You Post This?
Recruitment Tools in Addition
to the Ads
   Staff Know Rules Regarding Recruitment
       Training recruiters
   Recruitment Script
       Have IRB approved scripts or bullets to cover
       Have IRB approved documentation about the
        study, recruitment, and documentations
   Have The Staff To Handle The Volume.
    Make Sure You Have Staff To Take and/or
    Make Calls.
Recruitment Script Tips
   Introduce Yourself, Your Company And
    The Physicians (Study Team)
   Always Be Very Positive And Polite
   Ask The Patient If This Is A Good Time To
   Keep The Conversation Focused And
    Directed Toward Study Protocol Eligibility
Recruitment Script Tips
   Ask Direct Study Related Open-ended
   Do Not Pressure The Patient To Participate
   Answer All Questions
   Allow The Patient Time To Think About
   Give Contact Information
Be Prepared for Questions
   Know Your Stuff!
   Read The Study Protocol
   Know The Visit Schedule & Patient Visit
    Responsibilities, Tests, And Procedures
   Know The Patient Study Fee
Issues in Recruiting
Special Populations
Regulatory Issues
   Special Populations
       Who are they?
       Really need?
   Diversity of Sample
       If not diverse, why?
   Non-English Speakers
       If more than 3 of a specific language, need
        material translated
Recruiting Hard to Reach
       What Makes Groups Hard To Reach
        No known phone number
        unstable living situations,
        rapidly changing addresses, no known phone
        were incarcerated,
        moved in and out treatment programs.
Tips for Recruiting Hard to
   Understand There Is Gatekeeper Effect
       Agency staff are difficult to get to assist with
        recruitment (Lennox et al., 2005)
       Service providers can have difficulty with studies
        with control groups
   Educate Gatekeepers
   If Necessary, Figure Out How To Go Around
Tips for Recruiting Hard to
   Take Time to Establish Trust
   Trust Comes Up When Recruiting Certain
       African Americans
       Youth
   Trust Also Comes Up For The Following
    Health Issues:
       HIV
       Disability
       Drug Use
Tips – Establish Trust
   Multiple Respectful Contact With Participants
   Having Research Staff Recruit Vs. Outside Agency
   Allowing Potential Participants A Chance To “See”
    The Researcher (Stanford et al., 2003; Thomas et al.,
    2007 )
   Recruiting Clinicians Through Other Clinicians And
    Develop Ongoing Personal Contacts (Carey et al.
Tips for Recruiting Hard to
   Allow More Time for Recruitment Phase
       Study that looked at recruiting clients with a
        disability found:
           1 to 15 weeks with an average number of 5 weeks for
            1st client, 3-42 weeks for 10 clients
           4 to 42 weeks from when letter send to when the first
            client was interviewed, half of the agencies recruiting
            required 13 or more weeks.
Other Things to Think
Costs and Labor are Involved with
   Postage
   Stuffing Envelopes
   Monitoring Phones
   Monitoring Reply
   Hang Up Fliers
   Write Press Releases
   Setting up and maintaining website or
    electronic recruitment
Confidentiality Issues
   How Pass On Names?
       Need to encrypt electronic files or have https
   How Protect Recruitment Information At
    Office? In The Field?
       Locking bag or box
       Don’t collect names or identifying information –
        use codes
Retaining Those Who
        Are Recruited
Two Studies with High Retention
   NLST Enrolled 3,743 Participants Locally
    Over 18 Months
       Participants are in study for 7 years or 6/30/09
       Compliance rates are above 90%
   PLCO Enrolled 13,166 Participants Locally
    Over 6 ½ Years
       Special effort to enroll Latino/a subjects (1,046
        added to the trial)
       Participants were screened annually for 6 years
       Compliance rates are above 90%
Retention Tips from NLST & PLCO
   Greeting Cards
       Birthday cards
       Sympathy cards to participants
       Sympathy cards to family members when
        participants pass away
       Holiday cards each year
       Thinking of you cards if patient diagnosed with
TIP: Mail is also a great way to track if
anyone has moved
Retention Tips from NLST & PLCO
   Keep Them Informed About The Study
       E-mail address set up so the participants can ask
       Local newsletters (quarterly, yearly)
       Two national newsletters per year
       Website set up with general information on the study
   Personal Contact Over Informal Contact
       Instead of yearly questionnaires through the mail, did
        phone calls
   Celebrate Milestones
       At end of screening phase, held a special event
Contact Information
 Yvonne   Kellar-Guenther, Ph.D.
 University of Colorado Denver, Anschutz
 Medical Campus

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