John Needham Northwestern U lecture

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

Transcript of John Needham Northwestern U lecture

  • 1. 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

2. Todays Topics

  • The steps sponsors and site staff need to take to better recruit and retain participants
  • Understanding the relevance of Maslows 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 3. What Brings Us Together?

  • Recruitment is never going to be easier , only more difficult: more patients---longer trials
  • An opportunity existsto more effectively initiate studies, build patient awareness, improve retention and achieve your evaluable patient data goals

2008 Clinical Research Educational Conference 4. Know The Patients 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 5. Participants Information Needs 2008 Clinical Research Educational ConferencePercent of Respondents N=968Source: November 2002 Online Survey 6. Study Participants Concerns 2008 Clinical Research Educational Conference% Responding Source: Thomson CenterWatch Survey of 1239 Study Volunteers, 2004 7. The Staffs 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 ConferenceArchives of Internal MedicineSurvey 8. Retention Challenges 2008 Clinical Research Educational Conference 9. Keeping Participants Engaged

  • At any point in time, a participants 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 10. 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 11. Maslows Hierarchy of Needs 2008 Clinical Research Educational ConferenceDeficit Needs Being Needs 12. 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 13. 14. How Long Did You Have Your Medical Condition Before You Participated in a Clinical Trial? 2008 Clinical Research Educational ConferenceSource: February 2005 Volunteer Survey Percent of Respondents N= 534 Recruitment Insights 15. From The Time You First Heard About The Clinical Trial, How Long Before You Decided To Participate? 2008 Clinical Research Educational ConferenceSource: February 2005 Volunteer Survey Percent of Respondents N= 534 16. What is Most Important to Potential Participants Similarity of Patient Responsesin Three Therapeutic Areas PatientQuest Surveys HIV >250 responses OAB >400 responses Psoriasis >50 responses 17. Which would most likely affect your decision to participate in a trial? 2008 Clinical Research Educational ConferenceHIV Patients 18. Over Active Bladder Patients 2008 Clinical Research Educational Conference 19. Psoriasis Patients 2008 Clinical Research Educational Conference 20. Would you discuss trial participation with a partner, friend or family member? 2008 Clinical Research Educational Conference 21. If considering a trial, who, other than the study doctor, would you discuss the decision with? 2008 Clinical Research Educational Conference 22. Psoriasis 2008 Clinical Research Educational Conference 23. If considering a trial, who, other than the study doctor, would you discuss the decision with? 2008 Clinical Research Educational ConferenceEU Results 24. 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 ConferenceUS Results 25. 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 ConferenceEU Results 26. 11. Do you feel your regular doctor understands how youfeel about having OAB? 2008 Clinical Research Educational Conference 27. Do you feel your regular doctor understands how you feel about having OAB? 2008 Clinical Research Educational ConferenceEU Results 28. 2008 Clinical Research Educational ConferenceCan you or do you prefer to discuss your OAB with the nurses in your doctors office? 29. Can you or do you prefer to discuss your OAB with the nurses in your doctors office? 2008 Clinical Research Educational ConferenceEU Results 30. Which of the followingwould keep you interestedin participating in a study for a year or longer? 2008 Clinical Research Educational ConferenceHIV 31. Which of the following would keep you interested in participating in a study for 3 months or longer? 2008 Clinical Research Educational ConferenceUSA OAB Patients 32. Which of the following would keep you interested in participating in a study for 3 months or longer? 2008 Clinical Research Educational ConferenceEU OAB Patients 33. Psoriasis Patients 2008 Clinical Research Educational Conference 34. 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 35. 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 36. 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 37. Messages to the Sites

  • Humanize the Experience.
    • One of the top four motivators for participation in clinical trials among older adults isstaff 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 38. 7 Take Away Messages

  • Assess the feasibility for every study
  • Whatever you or anyonethinkswill work, it must be tested and proven; budget for it
  • Develop a site Recruitment Training Continuum
  • Never underestimate the multiple forces exerted on the patients mind set and their familys motivation
  • Archive what you have learned
  • You are in the business of delivering Evaluable Data
  • Fish where the fish are

2008 Clinical Rese