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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
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5. Participants’ Information Needs 2008 Clinical Research Educational Conference Percent of Respondents N=968 Source: November 2002 Online Survey
6. Study Participants’ Concerns 2008 Clinical Research Educational Conference % Responding Source: Thomson CenterWatch Survey of 1239 Study Volunteers, 2004
11. Maslow’s Hierarchy of Needs 2008 Clinical Research Educational Conference Deficit Needs Being Needs
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14. 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
15. 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
16. 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
17. Which would most likely affect your decision to participate in a trial? 2008 Clinical Research Educational Conference HIV Patients
23. If considering a trial, who, other than the study doctor, would you discuss the decision with? 2008 Clinical Research Educational Conference EU 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 Conference US 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 Conference EU Results
26. 11. Do you feel your regular doctor understands how you feel 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 Conference EU Results
28. 2008 Clinical Research Educational Conference Can you or do you prefer to discuss your OAB with the nurses in your doctor’s office?
29. 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
30. Which of the following would keep you interested in participating in a study for a year or longer? 2008 Clinical Research Educational Conference HIV
31. 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
32. 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
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.
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