Fuller, Angela (2015) [PDF]

199 Pages·2015·1.56 MB·English

UNDERSTANDING PARTICIPATION OF RACIAL AND ETHNIC GROUPS IN

MULTIPLE SCLEROSIS CLINICAL TRIALS

A Thesis

Presented to

The Faculty of the Department of Anthropology

San José State University

In Partial Fulfillment

of the Requirements for the Degree

Master of Arts

By

Angela Fuller

May 2015
© 2015

Angela Fuller

ALL RIGHTS RESERVED
The Designated Thesis Committee Approves the Thesis Titled

UNDERSTANDING PARTICIPATION OF RACIAL AND ETHNIC GROUPS IN

MULTIPLE SCLEROSIS CLINICAL TRIALS

By

Angela Fuller

APPROVED FOR THE DEPARTMENT OF ANTHROPOLOGY

SAN JOSÉ STATE UNIVERSITY

May 2015

Dr. Roberto Gonzalez Department of Anthropology

Dr. Guadalupe Salazar Department of Anthropology

Dr. Charlotte Sunseri Department of Anthropology
ABSTRACT

UNDERSTANDING PARTICIPATION OF RACIAL AND ETHNIC GROUPS IN
MULTIPLE SCLEROSIS CLINICAL TRIALS

By Angela Fuller

Multiple sclerosis (MS) patients from different racial and ethnic groups are
equally likely to participate in clinical trials despite the significant risk that
experimental drugs pose to their health. This is in contrast to existing literature
which points to minority group distrust of medical research as a reason for low
clinical trial participation rates. Given this disparity, the purpose of this thesis is
to understand the complexities surrounding MS clinical trial participation. A
mixed methods approach was utilized, including: 1) review of archival data for
racial and ethnic group clinical trial participation rates; 2) an electronic survey to
capture MS patient exposure to and knowledge of clinical trials; and 3) semi-
structured interviews to elucidate perceptions of clinical trial participation.
Despite the predicted influence of distrust on clinical trial participation rates, this
study identified no differences in motivations to participate among racial or ethnic
groups. Focusing only on minority distrust as a reason for low clinical trial
participation may overlook true patient motivations which are mediated, not by
arbitrary categories of race and ethnicity, but by balancing the complicated
interactions of distrust, risk perception and risk acceptance, with the perceived
benefits of clinical trial participation. These motivations are situated within the
context of structural barriers that can prevent clinical trial participation, such as
health care access and clinician bias.
ACKNOWLEDGEMENTS

I would like to extend my deepest appreciation to my thesis committee,
Dr. Roberto Gonzalez, Dr. Guadalupe Salazar, and Dr. Charlotte Sunseri, for
their support and guidance throughout this entire thesis process. It has been
such an important learning experience for which I am eternally grateful and will
not soon forget. I wish to give a special thank you to the multiple sclerosis
patients I was able to work with every day, who taught me so much about trust,
fear, patience, and hope. It was through their endless curiosity and inspiration
that I was able to finish this work. Finally, I would like to thank my family, friends,
and fellow graduate students for their continuous support and encouragement.
And to Micah, who never doubted that it could be done.

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TABLE OF CONTENTS

Chapter 1: Introduction ......................................................................................... 1
An Introduction to the Unknown ................................................................. 1
Clinical Trials 101 ...................................................................................... 2
Clinical Research Coordinator or Ethnographer? ...................................... 6
Objectives .................................................................................................. 9
Chapter 2: The Discourse of Multiple Sclerosis .................................................. 13
Multiple Sclerosis as Medical Diagnosis .................................................. 13
Multiple Sclerosis as Identity .................................................................... 17
An Epidemiological Story ......................................................................... 20
The Causation Hypotheses ...................................................................... 26
Missing Pages of the Epidemiological Story ............................................ 29
Chapter 3: Underrepresentation in Clinical Trials ............................................... 33
Reporting Rates of Clinical Trial Participants by Race and Ethnicity ....... 33
Are There Differences By Race and Ethnicity? ........................................ 36
Barriers to Clinical Trial Participation ....................................................... 40
Facilitators to Clinical Trial Participation .................................................. 44
Precautions .............................................................................................. 47
Chapter 4: The Anthropology of Clinical Trials ................................................... 52
The Inclusion-and-Difference Paradigm................................................... 52
Biopolitical Citizenship and the Illusion of Race ....................................... 54
Recruitmentology ..................................................................................... 61
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Risk .......................................................................................................... 64
Chapter 5: Research Design .............................................................................. 68
Research Questions ................................................................................ 68
Research Methods ................................................................................... 68
Institutional Approvals .............................................................................. 75
Chapter 6: Results .............................................................................................. 76
Archival Data ........................................................................................... 76
Electronic Survey ..................................................................................... 83
Semi-Structured Interviews ...................................................................... 93
Chapter 7: Discussion ...................................................................................... 161
Underrepresentation Exists .................................................................... 161
Distrust is Real but Not Absolute ........................................................... 166
Risk Perception ...................................................................................... 170
Why Participate in Clinical Trials? .......................................................... 172
References Cited .............................................................................................. 175

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LIST OF TABLES

Table 1: Four Phases of Clinical Trials ................................................................. 3
Table 2: Estimated Prevalence Rates of MS in the United States by Race and
Ethnicity ................................................................................................... 23

Table 3: MS Clinical Trial Participants in the US by Sex .................................... 77
Table 4: MS Clinical Trial Participants in the US by Race .................................. 79
Table 5: MS Clinical Trial Participants in the US by Ethnicity ............................. 80
Table 6: Demographics of MS Patients Served by BAMC MS Clinic .................. 81
Table 7: Demographics of MS Patients Participating in Clinical Trials at BAMC
MS Clinic .................................................................................................. 83

Table 8: Demographics of Electronic Survey Respondents ................................ 84
Table 9: Frequency of Survey Respondents’ Primary Reasons for Accepting
Participation in a Clinical Trial .................................................................. 88

Table 10: Frequency of Survey Respondents’ Primary Reasons for Declining
Participation in a Clinical Trial .................................................................. 88

Table 11: Degree of Influence on Participation in a Clinical Trial by Race or
Ethnicity ................................................................................................... 90

Table 12: Degree of Influence on Participation in a Clinical Trial by Sex ............ 91
Table 13: Degree of Influence on Participation in a Clinical Trial by Income
Level ........................................................................................................ 91

Table 14: Demographics of Interview Participants .............................................. 95
Table 15: Interview Participants’ Primary Reasons for Accepting Participation in a
Clinical Trial ........................................................................................... 109

Table 16: Interview Participants’ Primary Reasons for Declining Participation in a
Clinical Trial ........................................................................................... 110

Table 17: Current MS Clinical Trials Being Conducted at BAMC ..................... 141
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Table 18: Current FDA Approved MS Medications ........................................... 147

ix
LIST OF FIGURES
Figure 1: Four Clinical Courses of Multiple Sclerosis ......................................... 16

Figure 2: Percentage of Caucasian and non-Caucasian Respondents who have
Discussed Clinical Trial Participation with their Doctor, Nurse, or Research
Personnel ................................................................................................. 87
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