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Recruitment of Human Research Subjects in Clinical Research


Introduction: A systematic approach to subject recruitment and ... Public perception fueled by lay press, New York Times, Seattle Times, USA Today, LA Times ... – PowerPoint PPT presentation

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Title: Recruitment of Human Research Subjects in Clinical Research

Recruitment of Human Research Subjects in
Clinical Research
  • Introduction A systematic approach to subject
    recruitment and the evaluation of effective
    performance methods as well as the total success
    of the clinical research program.

  • Barriers and Challenges
  • Patient attitudes community standards,
    individual psychosocial factors about healthcare
    research, and negative publicity
  • Provider attitudes pressure from sponsor to
    recruit, inclusion/exclusion criteria, uneven
    recruitment planning
  • Sponsor attitudes unaware of research subject
    attitudes, pressure to develop new drugs in a
    timely and cost effective manner
  • Ethical contradications in the context of
    sponsoring, monitoring, and evaluating a clinical
    research program
  • Inclusion/exclusion criteria
  • Catch as catch can

RecruitmentNot an easy road
  • Wide concerns from FDA and DHHA
  • Growing concern over clinical trial recruitment
    strategies and tactics for ensuring adequate
    enrollment and retention
  • DHHS, Office of Inspector General Report, June
    2000, two part report
  • Public perception fueled by lay press, New York
    Times, Seattle Times, USA Today, LA Times

  • Patient (human research subject) attitudes.
  • Growing concern about their safety and how well
    they will be protected from research risks
    (perception is reality)
  • Newspaper articles
  • 1999 fifty articles that cast a shadow of doubt
    (including research-related deaths) over the
    clinical trial industry
  • See attached email dated April 28, 30, 2001

  • Financial Facts about research subject
  • Inadequate planning results in
  • 25 delays in new drug development programs
  • Average cost to recruit consumes 15 of budget
  • Of 163 Phase III clinical trials, 78 of sites
    missed enrollment deadlines
  • Average cost to recruit/enroll ranges from 1300
    to 2400, depends on complexity of trial

RecruitmentWhat the Sponsor needs to know
  • Pre Study Questionnaire (enrollment metrics)
  • What was the name of the study and what was the
  • What was the expected number of subjects to be
    enrolled at site?
  • What was the actual number of subjects screened
    at site and over what period of time?
  • How long (in months) did it take your site to
    reach enrollment?
  • How many patients did you complete?

RecruitmentOne of the most critical elements
  • Identifying, Recruiting, Enrolling patients is
    the most challenging part of any clinical trial
  • Participation rates are low 3 to 20 of
    potential subjects who are screened
  • Oncology patients enroll in clinical trials 8
    of the time

RecruitmentThe stark reality
  • Survey of oncology patients (Harris Feb 2001)
  • 5972 cancer patients surveyed about clinical
  • 85 unaware or unsure that participating in
    clinical trials was a treatment option
  • 75 said they would have been willing to
  • 33 said they would be better off taking standard
  • 29 feared they would receive placebo
  • 20 feared they would be treated like guinea
  • 18 feared doctor would not be able to choose
    best treatment

  • Survey of patients without cancer
  • Number in patient base not quoted in survey
  • 82 would consider enrolling
  • 56 feared receiving a placebo
  • 47 feared they would lose autonomy and decision
    making ability
  • 44 feared being treated like a guinea pig

RecruitmentThings are never as they appear
  • Recruitment flaws are the leading cause of
    clinical research failure
  • Lasagnas Law (Louis Lasagna, Tufts University)
  • Muenchs Postulates, Laws and Corollaries
  • Investigators overestimate the pool of available
    patients who meet inclusion criteria that are
    willing to participate in clinical research.

  • Funnel Effect of recruiting research subjects
    dwindling returns when screening
  • Illustrates the progressive shrinking of the
    research subject population prior to enrollment
  • Usually related to the clinical trial
  • End result is the number of research subjects who
    enter the clinical trial

  • Illustration of the Funnel Effect
  • 8027 research subjects screened
  • 3103 unavailable during key hours
  • 4254 preliminary exclusion
  • 21 not screened for various reasons
  • 258 rejected prior to interview
  • 53 rejected after interview
  • 92 not consenting
  • 146 not medicated
  • 100 research subjects enrolled

  • Why do all clinical investigators overestimate
    patient recruitment?
  • Inclusion criteria seriously restricts
    availability insufficient time reviewing
  • They are naïve to clinical research
  • Do not adequately consider the patients
    willingness to comply with the trial
  • Do not understand the patients interests and
    motivations in the treatment being tested

  • Stages of research subject recruitment
  • Pre-screening research subjects
  • Develop a recruitment strategy
  • Develop a plan to contact or reach patients
  • Contact referral groups
  • Utilize advertising medica (IRB approval needed)
    integrate into your budget
  • Carefully review your patient database against
    the inclusion and exclusion criteria
  • Is this study compatible with the practice

  • Stages of subject recruitment
  • Screening of research subjects
  • Discuss the clinical trial with the prospective
    research subject
  • Assess the patients initial interest based on
    study requirements and scheduling
  • Conduct initial screening questions using
    inclusion/exclusion as guide, use checklist, part
    of source documents
  • Conduct initial history, physical, and clinical
    laboratory screen (also special laboratories)
  • Re-screen or conduct a more detailed secondary
    screen to confirm labs, ask detailed questions,
    schedule additional tests
  • Obtain patients informed consent

  • Recruitment ? Compliance ? Retention
  • What motivates the patient to participate in a
    clinical trial?
  • Access to promising therapies
  • Access to greater medical expertise
  • Close ? Individualized medical attention/care
  • Emotional support
  • Something to do (break boredom)
  • Altruism (usually limited to Phase I)

  • Recruitment ? Compliance ? Retention
  • What are some of the concerns patients have about
    participating in clinical research? Will the drug
    and trial be safe?
  • What if I change my mind and decide to drop out?
  • Will I get a placebo or the real thing?
  • Whats in it for me?
  • Will I be taken advantage of?
  • Whats in it for my doctor?

RecruitmentGuidance on Advertising
  • Regulations 21 CFR 50.20, 50.25, 56.111(a)(3)
    and 812.20(b)(11)
  • Do not specifically address language and tone of
  • FDA Guidance Sheets FDA Information Sheets
    Guidance for IRBs and Clinical Investigators
  • Does provide sound advice

RecruitmentGuidance on Advertising
  • FDA Information Sheets Guidance for IRBs and
    Clinical Investigators
  • the procedure for recruiting subjects is not
    coercive and does not state or imply a certainty
    of favorable outcome or other benefit beyond what
    is outlined in the consent document and protocol.

RecruitmentGuidance on Advertising
  • FDA Information Sheets Guidance for IRBs and
    Clinical Investigators
  • No claims should be made, either explicitly or
    implicitly, that the drug, biologic or device is
    safe or effective for the purpose under

RecruitmentGuidance on Advertising
  • FDA Information Sheets Guidance for IRBs and
    Clinical Investigators
  • Advertising for recruitment into
    investigational drug, biologic or device studies
    should not use terms such as new treatment,
    new medication or new drug without explaining
    that the test article is investigational. A
    phrase such as receive new treatments implies
    that all study subjects will be receiving newly
    marketed products of proven worth.

RecruitmentGuidance on Advertising
  • FDA Information Sheets Guidance for IRBs and
    Clinical Investigators
  • Advertisements should not promise free medical
    treatment, when the intent is only to say (the)
    subject will not be charged for taking part in
    the investigation.

RecruitmentGuidance on Advertising
  • FDA Information Sheets Guidance for IRBs and
    Clinical Investigators
  • Advertisements may state that subjects will be
    paid, but should not emphasize the payment or
    amount paid.
  • FDA considers payment to research subjects to be
    a recruitment incentive, not a benefit of

RecruitmentGuidance on Advertising
  • FDA Information Sheets Guidance for IRBs and
    Clinical Investigators
  • any advertisement to recruit (research) subjects
    should be limited to the information the
    prospective subjects need to determine their
    eligibility and interest.
  • Name and address of clinical investigator
  • Condition under investigation and/or purpose
  • Summary of criteria used to determine elegibility
  • Brief list of benefits, if any
  • Time commitment required of subject
  • Location of research and name/telephone number of
    contact person

RecruitmentGuidance on Advertising
  • When writing or reviewing a research subject
    recruitment advertisement, points to consider
  • Could the language be coercive?
  • Does the description of the study procedures
    accurately reflect the study design?
  • Will the subjects undergo procedures or tests
    that carry risk or cause discomfort?
  • Will the audience to whom the ad is directed
    understand the significance of the language used?
  • Does the language comply with FDA guidance?

RecruitmentHow to plan your recruitment strategy
  • Identify the target research population
  • Develop a recruitment timeline with milestones
  • Develop a profile of potential research subjects
  • Verify sources of potential subjects
  • Determine methods of approaching each source
  • Identify recruitment advertising media
  • Develop materials (IRB)
  • Develop a questionnaire (source document)
  • Develop plan on how you will process potential

RecruitmentHow to plan your recruitment strategy
  • Develop plan on how you will obtain informed
    consent and screen potential research subjects
  • Decide how you will evaluate performance metrics
    (established benchmarks) and develop corollary
    methods to accomplish your recruitment goals
  • Document your recruitment strategy and share it
    with your sponsor
  • Last but not least, make absolutely sure that
    your study related budget has money to support
    your efforts!
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