The Problem of Selection Bias – Disparities by Race and Ethnicity among adults recruited for a Preclinical Alzheimer’s Disease Trial at Michigan Medicine
Excerpt: As a research participant, Whole Dude investigates the problem of Selection Bias in the Selection Process used by the Research Investigator at University of Michigan. The Selection Bias is inherent in the Selection process for it is gathering information of its human subjects outsides the boundaries of the declared purpose of the Study.
Informed Consent For the Michigan Medicine AHEAD 3-45 Study Screening Procedures
On Tuesday, December 05, 2023, Whole Dude signed the Informed Consent Form for the AHEAD 3-45 Study Screening Procedures. Reference: UM eResearch ID: HUM00178622; NIA & Eisai Inc. / Protocol Number BAN2401-G000-303
I was informed about an Institutional Review Board (IRB) and was instructed to contact the Study Subject Adviser, Advarra IRB to report my concerns or complaints regarding this research study. I contacted Advarra IRB on December 28 to share my concerns about my exclusion from the study due to the problem of Selection Bias. The following is a copy of that communication sent to the Study Subject Adviser:
Dear Study Subject Adviser,
REFERENCE NUMBER: Pro00041484
As a research participant, I am investigating the problem of Selection Bias in the Selection Process used by the Research Investigator at University of Michigan.
I am informed that I am excluded from further participation in this Study and I want to verify the results of the blood and urine samples I provided on December 05, 2023 to ascertain the fact of my exclusion from the Study is consistent with the Research Protocol for which I have given my written consent.
In any case, I shall hold University of Michigan to its primary responsibility to share the lab test results for it has issued me a Medical Registration Number and informed me about this Hospital Appointment and provided me the assurance that the lab results will be shared with the patient.
Whole Dude investigates Whole Bias at Michigan Medicine
University of Michigan and Michigan Medicine must reject the concept of Race and Ethnicity to describe Asian/Indian Identity
Selection bias refers to systematic differences between baseline characteristics of the groups that are compared. The unique strength of randomization is that, if successfully accomplished, it prevents selection bias in allocating interventions to participants. Its success in this respect depends on fulfilling several interrelated processes. A rule for allocating interventions to participants must be specified, based on some chance (random) process. We call this sequence generation. Furthermore, steps must be taken to secure strict implementation of that schedule of random assignments by preventing foreknowledge of the forthcoming allocations. This process if often termed allocation concealment, although could more accurately be described as allocation sequence concealment. Thus, one suitable method for assigning interventions would be to use a simple random (and therefore unpredictable) sequence, and to conceal the upcoming allocations from those involved in enrolment into the trial.
University of Michigan and Michigan Medicine must learn that there is no human race called Indian
Excerpt: The Michigan Medicine AHEAD study is examining the efficacy of a medication aimed at preventing Alzheimer’s Disease in individuals at increased risk of developing the disease. The study has, however, faced criticism regarding its focus on years of schooling and its lack of a research protocol to verify the identity and individuality of the human organism. Critics assert that biological processes like the flow of biological information and protein synthesis are not influenced by education level and that individuality should not be tied to factors such as race and ethnicity. The conceptualization of “life as knowledge in action” and that it is an interplay of cellular function and knowledge must be explored.
The following is a copy of the automated response sent by Advarra Adviser (IRB)
From: Advarra Adviser
Thank you for your email. Advarra offices will be closing at 3pm Friday, December 22nd and will be closed through Monday January 1, 2023 for our Holiday Break. Emails sent during this time will be addressed the following business day, Tuesday, January 2nd.
Please note – questions regarding:
*Compensation
*Scheduling
*Test Results
*Study equipment
*Consent form questions
*Enrolling or withdrawing from a studyShould be discussed directly with the research staff. The research staff contact information can be found on the first page of the consent form.
My reply to the automated response sent by Advarra Adviser (IRB):
Thanks for your email. My concern is about the research protocol for which the research scientist obtained my written consent. I am not asking you about the Consent Form Questions. I am asking you to verify the legitimacy of the Research Project to ask the Questions on the Consent Form. Firstly, the AHEAD Study did not disclose that the Study is constructed on the basis of creating a profile information of each research subject. Secondly, the Questions asked have no scientific validity; the information provided has no relevance to the study of this investigational drug. It seems that there is some other agenda is at work to use this research to gather information about research subjects without any concern for the randomization of the selection of research subjects.
The Selection Bias is inherent in the Selection process for it is gathering information of its human subjects outsides the boundaries of the declared purpose of the Study.
The AHEAD Study is researching the safety and effectiveness of an investigational medication in people who might be at increased risk for developing memory loss associated with Alzheimer’s Disease. The study is looking for participants age 55-80 years old, who have generally normal memory function in daily life, and who are not being treated for memory problems. For individuals age 55-64 years old, an additional risk factor is required, such as a parent or sibling with Alzheimer’s Disease or previous biomarker testing showing increased risk for developing Alzheimer’s Disease. This study sees participants in Ann Arbor. Contact Lauren Mackenzie at spearsl@med.umich.edu or 734-232-2415.
On Tuesday, December 05, 2023, at the Michigan Clinical Research Unit (MCRU) at the Cardiovascular Center (CVC), I was interviewed for participating in the AHEAD Study and I completed the Stage 1A of the Screening process. I am asked to provide information about the most important occupation of my life, my sexual orientation, my race and ethnicity, my place of birth and the country of origin, the total number of years I spent in the School to register my personal identity for participation in the Medical Research Project. The Research Protocol has not identified the basis for discovering the identity of a multicellular human organism. I can answer the questions I am asked. Do I have the ability to communicate my answers to the cells of my own body and reflect that identity in the living functions they perform to keep me alive?
Racial and Ethnic Differences in Plasma Biomarker Eligibility in a Preclinical Alzheimer’s Disease Trial
- December 2023
- Alzheimer’s & dementia: the journal of the Alzheimer’s Association19(S24)
Authors: Doris P. Molina-Henry, Rema Raman, Andy Lou, Oliver Langford and others, University of Southern California
Abstract:
Background: In Alzheimer’s disease (AD) trials, differential screen failure due to cognitive and biomarker requirements may contribute to underrepresentation of racially and ethnically minoritized groups. The AHEAD 3‐45 Study (NCT04468659) is an ongoing program testing lecanemab at the stage of preclinical AD that utilizes plasma biomarker prescreening, acquired before cognitive, clinical, and medical history eligibility assessments, to enrich for participants likely to qualify based on amyloid PET eligibility criteria. Methods: We examined the frequency of plasma amyloid biomarker eligibility among racial and ethnic groups in the AHEAD Study. We assigned participants ages 55‐80 to mutually exclusive groups: Hispanic Black (HB), Hispanic White (HW), Non‐Hispanic Asian (NHA), Non‐Hispanic Black (NHB), and Non‐Hispanic White (NHW). We used univariate logistic regression models to explore group differences in screen failure rates as determined by an algorithm that includes the plasma Aβ 42/40 ratio, age, and APOE status. The algorithm indicates an adequately high probability of elevated brain amyloid (>20 centiloids). We further explored whether APOE ε4 status (carrier vs non‐carrier) contributed to group differences. Results Among 4274 participants undergoing plasma screening, 59 (1.4%) were HB, 622 (14.6%) were HW, 74 (1.73%) were NHA, 329 (7.7%) were NHB, and 3190 (74.6%) were NHW. Screen failure rates were 86% for HB, 76% for HW; 80% for NHA; 77% for NHB, and 62% for NHW. Using NHW participants as a reference group, we observed increased odds of screen failure among all other groups (HB OR = 4.0 95% CI 2.0, 9.1; HW OR = 2.0 95% CI 1.6, 2.4; NHA OR = 2.5 95% CI 1.4, 4.5; NHB OR = 2.1, 95% CI 1.6, 2.7). Observed differences were consistent across APOE ε4 carriers and non‐carriers. Conclusion: Differential rates of amyloid eligibility were observed despite the lack of systematic sample bias due to clinical or cognitive requirements observed in previous studies. Potential explanations for these observations include differences in clinical trial access, incidences of elevated amyloid, needed cutoffs for biomarker assays, and confounding due to comorbidities or other unmeasured covariates. This work is supported by a public‐private partnership between Alzheimer’s Clinical Trial Consortium (U24 AG057437) and Eisai.
Disparities by Race and Ethnicity Among Adults Recruited for a Preclinical Alzheimer Disease Trial
Rema Raman, PhD1; Yakeel T. Quiroz, PhD2,3; Oliver Langford, MS1; et al
Key Points
Question: Are there racial/ethnic differences associated with recruitment sources and reasons for ineligibility among preclinical Alzheimer disease clinical trial participants?
Findings: In this cross-sectional study of screening data for 5945 participants from a preclinical Alzheimer disease trial, Black, Hispanic, and Asian participants were recruited from local efforts compared with White participants who were recruited from more distributed efforts. Adjusted analysis showed that underrepresented racial/ethnic communities were more likely to be ineligible after the first screening visit.
Meaning: These findings suggest that there are racial and ethnic disparities in preclinical AD clinical trial enrollment that will require a comprehensive approach to study design and recruitment strategies to minimize disproportionate enrollment.
Abstract
Importance: Underrepresentation of many racial/ethnic groups in Alzheimer disease (AD) clinical trials limits generalizability of results and hinders opportunities to examine potential effect modification of candidate treatments.
Whole Dude - Whole Spirituality 