key: cord-0772955-209ynaun
authors: Patel, Eshan U.; Zhu, Xianming; Quinn, Thomas C.; Tobian, Aaron A.R.
title: Public Knowledge and Attitudes Toward Clinical Trials in the COVID-19 Era
date: 2021-10-08
journal: Am J Prev Med
DOI: 10.1016/j.amepre.2021.09.002
sha: cea8ba8f18f523952f15823b9894c4ae59aa8ed1
doc_id: 772955
cord_uid: 209ynaun

nan

Participant enrollment in clinical trials is challenged by a multitude of structural-, clinical-, physician-, and individual-level barriers to participation. 1 In addition to slow clinical trial accrual, there is often under-representation of racial/ethnic minorities who encounter even greater barriers. 2, 3 The coronavirus disease 2019 (COVID-19) pandemic has further challenged participant enrollment. 4 Nationally representative data on attitudes toward clinical trials are limited. This cross-sectional study aims to describe perceived knowledge, trusted informational sources, and attitudes about clinical trial participation overall and by race/ethnicity in the U.S.

The Health Information National Trend Survey (HINTS 5, Cycle 4) was conducted between February 24, 2020 and June 15, 2020 by the National Cancer Institute. This is a mailed complex survey of U.S. civilian, non-institutionalized adults aged 18 years (response rate=37%). 5 Respondents completed a self-administered mail questionnaire on demographic and healthrelated information. This analysis of publicly available data was deemed exempt from review by the Johns Hopkins University School of Medicine IRB.

Descriptive statistics were used to describe perceived knowledge and trusted informational sources about clinical trials, and perceived factors that would influence clinical trial participation overall and by race/ethnicity. Rao-Scott chi-square tests were used to assess differences by race/ethnicity. Analyses accounted for the complex survey design and incorporated jackknife replicate sampling weights using Stata/MP, version 15.2. Except sample sizes, all reported data were weighted.

There were 3,865 respondents. The mean age was 48 (SD=18.1) years; 47.6% (n=1,561) were male, 50.2% (n=2,204) were female, and 2.2% (n=100) did not report their sex; and 58.7% (n=2,133) were non-Hispanic White, 10.3% (n=481) were non-Hispanic Black, 15.7% (n=596)

were Hispanic, 7.9% (n=280) were of other race/multiracial, and 7.3% (n=375) did not report their race/ethnicity. 

In this national survey, there was limited perceived knowledge about clinical trials, which was even lower among some racial/ethnic minority groups (e.g., Hispanics). Notably, healthcare providers were the most trusted informational source on clinical trials, regardless of race/ethnicity. These data support leveraging healthcare providers in the provision of clinical trial information; however, this alone is unlikely to sufficiently improve racial/ethnic representation. Indeed, there were important racial/ethnic differences in the degree of confidence in one's doctor to influence their decision to participate in a clinical trial. In addition, the decision to participate is complex, 6 and racial/ethnic minorities face numerous systemic barriers to clinical trial participation beyond individual-level knowledge and attitudes. 2, 3, 7, 8 Limitations This study may be limited by selection bias. There was a high non-response rate and it is likely that respondents are more likely than non-respondents to participate in research, perhaps leading to overestimates of knowledge and positive attitudes. Also, data were collected during the early 5 phase of the pandemic, which may have influenced responses. Furthermore, reported attitudes may not be generalizable to all patient populations or apply to all trials with varying intensities of study requirements.

These data combined with decades of research underscore that concerted efforts, including improving health literacy and patient trust, are needed to ensure diversity, equity, and inclusion in clinical trials. 3,9, 

Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation

A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders

Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop

Association of the coronavirus disease 2019 (COVID-19) outbreak with enrollment in cancer clinical trials

Data resource profile: the National Cancer Institute's Health Information National Trends Survey (HINTS)

Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis

Exploring the engagement of racial and ethnic minorities in hiv treatment and vaccine clinical trials: a scoping review of literature and implications for future research

When offered to participate": a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials

Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review

Increasing diversity in clinical trials: overcoming critical barriers