John Needham Northwestern U lecture
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John Needham Northwestern U lecture

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similarities to patient attitudes toward clinical trials w/i disease states

similarities to patient attitudes toward clinical trials w/i disease states

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  • Endorsement by the senior management and acceptance by the teams are essential. Otherwise the department will wither on the vine.
  • Whether you know this patient population or it is new to you, here are some important questions to use as a barometer for how well you DO know the patients, how their condition affects their quality of life and if there is sufficient motivation to join a trial to do something about it. How often they routinely visit the doctor should be measured against the study enrollment period. You may need to reach out to patients who will routinely visit the office after the enrollment period. This is a good time to get in touch with patients who have previously participated in studies for you and ask them for their opinions of this study design.
  • When patients know what to expect and what they experience in the trial is in line with what they were expecting, then enrollment and retention will increase. Early education is very important both from an ethical and legal perspective. Only through providing educational materials can we help patients to feel that they have control of the decision and participation process.
  • Very interesting—probably the one thing the sites are not good at is flexible hours.

John Needham Northwestern U lecture John Needham Northwestern U lecture Presentation Transcript

  • Assessing, Understanding And Addressing The Needs Of Potential Study Participants And Their Families John Needham CEO Patient Recruitment Strategy, LLC PatientQuest Clinical Trial Brands 2008 Clinical Research Educational Conference What Focus Group Research Has Taught Us About Motivations and Barriers to Clinical Trial Participation
  • Today’s Topics
    • The steps sponsors and site staff need to take to better recruit and retain participants
    • Understanding the relevance of Maslow’s Hierarchy of Needs to trial participation
    • The results of recent participation surveys indicating participants greatest needs
    • Examples of patient education materials used to help participants overcome barriers to study participation
    2008 Clinical Research Educational Conference
  • What Brings Us Together…?
    • Recruitment is never going to be easier , only more difficult: more patients---longer trials
    • An opportunity exists to more effectively initiate studies, build patient awareness, improve retention and achieve your evaluable patient data goals
    2008 Clinical Research Educational Conference
  • Know The Patient’s Mindset
      • How do they feel about their disease and the impact on their daily life.
      • Do they know what a clinical trial is?
      • What would they want to know about one?
      • What would their barriers to participation be?
      • What would allay their concerns?
      • How far will they travel to a specialist or clinic?
      • How do they feel about the study requirements?
      • Is there a bias in the severity of the condition?
    2008 Clinical Research Educational Conference
  • Participants’ Information Needs 2008 Clinical Research Educational Conference Percent of Respondents N=968 Source: November 2002 Online Survey
  • Study Participants’ Concerns 2008 Clinical Research Educational Conference % Responding Source: Thomson CenterWatch Survey of 1239 Study Volunteers, 2004
  • The Staff’s Bedside Manner
    • 78% of patients want the physician to shake their hand during the first encounter
    • 56% of patients want physicians to introduce themselves using their own first and last names
    • 50% of patients want their first name used by the physician
    • 24% of patients want the physician to use their first and last names
    2008 Clinical Research Educational Conference Archives of Internal Medicine Survey
  • Retention Challenges 2008 Clinical Research Educational Conference
  • Keeping Participants Engaged
    • At any point in time, a participant’s motivation can vary through any aspect of the therapeutic program
    • Listen for the signs of loss of interest helping and try to resolve ambivalence
    2008 Clinical Research Educational Conference
  • Barriers
    • “ What might get in the way of your participation?”
      • Logistical Barriers – time, transportation, cost
      • Attitudinal Barriers – what if randomized to their less preferred group
      • Social Barriers – quality and quantity of family support
      • Health Barriers – complicating co-morbid medical or emotional conditions
      • Work Barriers – job travel or anticipated job changes, schedule flexibility
    2008 Clinical Research Educational Conference
  • Maslow’s Hierarchy of Needs 2008 Clinical Research Educational Conference Deficit Needs Being Needs
  • The Theory of Motivation
    • 1. Physiological (hunger, thirst, shelter, sex)
    • 2. Safety (security, protection from harm)
    • 3. Social (affection, belonging, acceptance, friendship)
    • 4. Esteem (also called ego). Internal: self respect, autonomy, achievement; External: status, recognition, attention.
    • 5. Self actualization (doing things, taking positive action steps)
    2008 Clinical Research Educational Conference
  •  
  • How Long Did You Have Your Medical Condition Before You Participated in a Clinical Trial? 2008 Clinical Research Educational Conference Source: February 2005 Volunteer Survey Percent of Respondents N= 534 Recruitment Insights
  • From The Time You First Heard About The Clinical Trial, How Long Before You Decided To Participate? 2008 Clinical Research Educational Conference Source: February 2005 Volunteer Survey Percent of Respondents N= 534
  • What is Most Important to Potential Participants Similarity of Patient Responses in Three Therapeutic Areas PatientQuest Surveys HIV >250 responses OAB >400 responses Psoriasis > 50 responses
  • Which would most likely affect your decision to participate in a trial? 2008 Clinical Research Educational Conference HIV Patients
  • Over Active Bladder Patients 2008 Clinical Research Educational Conference
  • Psoriasis Patients 2008 Clinical Research Educational Conference
  • Would you discuss trial participation with a partner, friend or family member? 2008 Clinical Research Educational Conference
  • If considering a trial, who, other than the study doctor, would you discuss the decision with? 2008 Clinical Research Educational Conference
  • Psoriasis 2008 Clinical Research Educational Conference
  • If considering a trial, who, other than the study doctor, would you discuss the decision with? 2008 Clinical Research Educational Conference EU Results
  • Other than receiving a new medical treatment for OAB, what else would interest you in joining and remaining in a clinical research study? 2008 Clinical Research Educational Conference US Results
  • Other than receiving a new medical treatment for OAB, what else would interest you in joining and remaining in a clinical research study? 2008 Clinical Research Educational Conference EU Results
  • 11. Do you feel your regular doctor understands how you feel about having OAB? 2008 Clinical Research Educational Conference
  • Do you feel your regular doctor understands how you feel about having OAB? 2008 Clinical Research Educational Conference EU Results
  • 2008 Clinical Research Educational Conference Can you or do you prefer to discuss your OAB with the nurses in your doctor’s office?
  • Can you or do you prefer to discuss your OAB with the nurses in your doctor’s office? 2008 Clinical Research Educational Conference EU Results
  • Which of the following would keep you interested in participating in a study for a year or longer? 2008 Clinical Research Educational Conference HIV
  • Which of the following would keep you interested in participating in a study for 3 months or longer? 2008 Clinical Research Educational Conference USA OAB Patients
  • Which of the following would keep you interested in participating in a study for 3 months or longer? 2008 Clinical Research Educational Conference EU OAB Patients
  • Psoriasis Patients 2008 Clinical Research Educational Conference
  • Key Findings
    • Regardless of the condition, addressing potential side effects with a potential participant is of paramount importance
    • Participants need user friendly literature about the study to share with their family and their family doctor
    • Participants want to talk with specialists or providers on an on-going basis if they are going to remain in a study
    2008 Clinical Research Educational Conference
  • Participants have expectations:
    • travel / parking expenses provided
    • strong desire to meet other participants
    • supportive website just for the study participants
    • mechanism to tell their friends or support group members about the study
    • progress reports through the course of the trial on how they are responding to the treatment
    2008 Clinical Research Educational Conference
  • Barriers to participation are:
    • driving too far to a site (pain)
    • flexible hours at the site for visits
    • too many visits through the course of the study (inconvenience)
    • injectable treatment (fear of needles)
    2008 Clinical Research Educational Conference
  • Messages to the Sites
    • Humanize the Experience.
      • One of the top four motivators for participation in clinical trials among older adults is staff rapport .
    • Give empathy to the Patient.
      • Pay attention, ask questions.
    • Be of service to the caregiver
      • Learn about available community resources
      • The smallest kindness means more than you can imagine to a family caregiver.
    • Smile and say Thank you!
    2008 Clinical Research Educational Conference
  • 7 Take Away Messages
    • Assess the feasibility for every study
    • Whatever you or anyone thinks will work, it must be tested and proven; budget for it
    • Develop a site Recruitment Training Continuum
    • Never underestimate the multiple forces exerted on the patient’s mind set and their family’s motivation
    • Archive what you have learned
    • You are in the business of delivering “Evaluable Data”
    • “ Fish where the fish are”
    2008 Clinical Research Educational Conference
  • Tools sites request in surveys
    • Over 90% of sites want:
      • Visit by Visit card
      • A study brochure
      • A patient/caregiver brochure
      • Print advert template
      • A Study web Site
      • Patient Travel Voucher
      • Inclusion/exclusion cards
      • Written “Welcome Letter”
      • A Farewell Kit
      • Appointment Reminder Cards
    • Over 80% additionally want:
      • Screening Post it Notes
      • Study Posters
      • E-newsletters
      • PI’s “Dear Patient” letter
      • Training Webinars
    2008 Clinical Research Educational Conference