Attitudes on participation in clinical drug trials: A nationally representative survey of older adults with multimorbidity

Author:

Schwartz Janice B.1ORCID,Liu Ruey‐ying2ORCID,Boscardin John3ORCID,Liu Qi4ORCID,Lau S. W. Johnny4ORCID,Khatri Sadhna5ORCID,Tarn Derjung6ORCID

Affiliation:

1. Department of Medicine, Division of Geriatrics and Division of Clinical Pharmacology University of California San Francisco California USA

2. Department of Sociology, National Chengchi University Taipei Taiwan

3. Department of Medicine and Department of Epidemiology and Biostatistics University of California San Francisco USA

4. Center for Drug Evaluation and Research Office of Translational Sciences and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Springs Maryland USA

5. Center for Biologics Evaluation and Research, Office of Compliance Biologics Quality U.S. Food and Drug Administration Silver Springs Maryland USA

6. Department of Family Medicine University of California Los Angeles California USA

Abstract

AbstractBackgroundOlder adults with multimorbidity are under‐represented in clinical drug trials. Their inclusion will not increase unless they are willing and able to participate. Data on motivators and barriers to participation in trials of new medications of older adults with multimorbidity are needed.MethodsCross‐sectional internet and telephone survey of a nationally representative sample of adults ≥65 years with ≥3 chronic conditions (NORC University of Chicago Amerispeak Panel) conducted from March–April, 2023 to determine motivators and barriers to drug trial participation, described graphically and using statistics.ResultsSurveyed 1318 (1142 Internet, 176 phone) with mean age 72.3 ± 6.3 (SD), 52% women; race: 83% White, 10% Black or African American, 5% Hispanic or Latino, 1.1% Asian; 4.4 ± 1.9 chronic conditions (of 16 queried), taking 7.5 ± 3.3 medications. Barriers included fear of side effects (48%), taking too many medications (44%), placebo (44%), mobility (33%), bathroom needs (25%), hearing (19%), eyesight (15%), video visits (33%; higher in women, Black or African‐American respondents, and those ≥80 years). Sixty‐five percent would join all in‐person trials, 49% would join all‐video trials. Travel >1 h was difficult for 66%, most difficult for women. Trust was a concern in 25% of Black respondents. Caregiving responsibilities or lack of time were not obstacles. Participants were most likely to consider a drug trial for a problem they have (63%) versus prevention (44%) and if invited by a physician (80%) or University healthcare system (58%). Getting better care was ranked very important (79%) followed by helping others (57%).ConclusionsMajor concerns of older patients with multimorbidity about participation in drug trials are potential side effects, taking too many medicines, and video visits. Physicians have the greatest influence on decisions and in‐person visits are preferred. Proposed changes in trial design to increase enrollment of under‐represented older adults may not align with patient‐reported preferences.

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Reference34 articles.

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