Janice B. Schwartz

Older adults, women, and minorities are under‐represented in clinical trials. Our objective was to identify characteristics predicting participation in clinical trials of medications in a diverse sample of older adults; and, secondarily, identify current participation motivators and barriers and trial preferences. A cross‐sectional U.S. community convenience sample survey of adults > 65 years with > 3 chronic medical conditions querying attitudes about participation in clinical trials was conducted from March 2023–October 2024 in English and Spanish. Formats were yes/no or three‐point Likert scale answers. Multivariable logistic regression identified characteristics with higher likelihood of trial participation. Surveys were from 2176 older adults (White (50.3%), Black/African American (18.5%), Hispanic/Latino (17.7%), Asian (13.5%) aged 73.1 ± 6.1 years (mean, SD), 52% women,one 4.1 ± 1.9 medical conditions; taking 7.4 ± 3.2 medications. Characteristics with higher likelihood of trial participation were higher income (1.36, 0.93–1.99; Odds Ratio, 95% Confidence Interval), educational status (1.88, 1.12–3.0), greater health literacy (2.07, 1.29–3.3), having cancer (1.49, 1.11–1.99) or chronic pain (1.55, 1.17–2.06), Black/African American race (1.44, 1.02–2.02) or Hispanic/Latino race/ethnicity (1.55, 1.11–2.16). Females had lower likelihood of participation (0.66, 1.29–3.32) as did age 75 and above (0.67, 0.50–0.92). Disincentives in women were potential side effects, placeboes, visit travel > 1 h, and video visits. Prior participants and nonparticipants were more likely to consider participation after physician recommendation (92% and 76.4%, respectively). Better care would motivate the highest percentage of all respondents. Education about trials including possible benefits, addressing concerns of women, physician involvement during recruitment and trials with in‐person visits may increase representative enrollment.

Background: Older adults with multimorbidity have been under‐represented in clinical drug trials. We sought to determine willingness to enroll in trials and preferences of older adults for learning about clinical trials, visit frequency, travel, locations, and testing. Methods: Cross‐sectional internet and telephone survey of a nationally representative sample of adults ≥ 65 years with ≥ 3 chronic conditions ( NORC University of Chicago Foresight 50+ panel) from March–April 2023 to determine acceptability of aspects of clinical trials. Results: Surveyed 1318 (1142 Internet, 176 phone), mean age 72.3 ± 6.3 ( SD ), 52% women; race: 83% White, 10% Black or African American ( BLAfrAm ), 5% Hispanic or Latino, 1.1% Asian; 4.4 ± 1.9 chronic conditions (of 16 queried), taking 7.5 ± 3.3 medications. Almost half would consider trials of medications for memory problems, hypertension, cancer, chronic pain, diabetes, or high cholesterol. Men and BLAfrAm respondents were the most willing to consider hypertension or diabetes trials. Preferences for where to learn about trials were physician offices (87% overall, 85% of BLAfrAm , 94% of Hispanic); 10% of White respondents considered senior centers versus 30% of BLAfrAm and 20% of Hispanics ( p < 0.001). Two‐thirds wanted written materials and question and answer sessions (no significant sex or racial differences). Respondents anticipated no difficulty with measuring blood pressure at home, and only respondents > 80 years anticipated difficulty wearing activity monitoring devices. All groups preferred monthly or every 3–4 month visits for physical exams, blood or urine tests vs. less frequently and were willing to travel half an hour in each direction for visits. Conclusions: Efforts to increase enrollment of older adults and older adults from previously under‐represented racial populations will need increased physician engagement. Pragmatic trials with infrequent participant contact are not likely to increase participation of older adults with multimorbidity.

In this issue, Zakout discusses European Union (EU) legal provisions for inclusion of patients of all types in clinical trials.¹ Shee highlights the unfortunate failure to include adequate numbers of older adults and adults with disabilities in clinical trials of anti-cancer agents. We agree with her argument that this is an ethical issue as well as a scientific and clinical issue.

Under‐representation of subgroups of the population in clinical trials has been and continues to be a problem despite goals of academia, industry, and government. Older adults are among the groups that are under‐represented in trials of medications that they are likely to receive once marketing approval has been received. Recent legislation that mandates that clinical trial participants be representative of patient population has been passed and creates hope that greater numbers of older adults will be enrolled in clinical trials and that they will be representative of “typical” geriatric patients. However, there is the need for collection of current data on disease prevalences with granularity as to age, gender, and race as well as geriatric co‐morbidities to assess the representativeness of clinical trial participants relative to patient populations. Consensus on definitions and collection of data relevant to geriatric patient populations are needed to evaluate effects of comorbidities, frailty, cognitive and physical function. There will also be a need for expansion of the geriatric research workforce, facilities for research both in academic centers but also in the community and long‐term care facilities, and for engagement with and involvement of communities that have been traditionally under‐represented to conduct clinical trials that enroll truly representative patient populations.

The International Union of Basic and Clinical Pharmacology (IUPHAR) Geriatric Committee aims to improve the use of drugs in older adults and develop new therapeutic approaches for the syndromes and diseases of old age through advocacy, education, and research. In the present paper, we propose strategies relevant to drug development and evaluation, spanning preclinical and the full range of clinical studies. Drugs for older adults need to consider not only age, but also other characteristics common in geriatric patients, such as multimorbidity, polypharmacy, falls, cognitive impairment, and frailty. The IUPHAR Geriatric Committee's position statement on ‘Measurement of Frailty in Drug Development and Evaluation’ is included, highlighting 12 key principles that cover the spectrum of translational research. We propose that where older adults are likely to be major users of a drug, that frailty is measured at baseline and as an outcome. Preclinical models that replicate the age, frailty, duration of exposure, comorbidities, and co‐medications of the proposed patients may improve translation. We highlight the potential application of recent technologies, such as physiologically based pharmacokinetic–pharmacodynamic modeling informed by frailty biology, and Artificial Intelligence, to inform personalized medicine for older patients. Considerations for the rapidly aging populations in low‐ and middle‐income countries related to health‐care and clinical trials are outlined. Involving older adults, their caregivers and health‐care providers in all phases of research should improve drug development, evaluation, and outcomes for older adults internationally.

Background: Older 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. Methods: Cross‐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. Results: Surveyed 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%). Conclusions: Major 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.

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