Drug Research and Development for Adults Across the Older Age Span Proceedings of a Workshop (2021) / Chapter Skim
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2 Inclusion of Older Adults in Clinical Trials: An Evolving Landscape
2 Inclusion of Older Adults in Clinical Trials: An Evolving Landscape
Pages 5-18
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From page 5... ...
Jerry Gurwitz, executive director of Meyers Primary Care Institute and division chief of geriatric medicine at the University of Massachusetts Medical School, introduced the first session of the workshop, which was designed to leave participants with "a healthy dose of reality about where we are and the future." The objectives of the session were to review the 5
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From page 6... ...
To study this question, RCTs have restrictive inclusion and exclusion criteria, as well as age criteria, with the aim of having a homogeneous population that differs only by study drug exposure (Zulman et al., 2011)
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From page 7... ...
Even when older adults are included in clinical trials, she said, there is no guarantee that those individuals are representative of the wide heterogeneity that exists in older adults. For example, of three older adults, one may be in her 90s but may still be healthy, with the exception of high blood pressure; another may be in her 70s and also suffering from rheumatoid arthritis, diabetes, chronic obstructive pulmonary disease, and low vision; and another may have movement challenges due to Alzheimer's and lumbar stenosis.
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From page 8... ...
Similarly, nursing home placement is dependent on factors such as the number of nursing home beds available in the area, and whether the person is financially able to "age in place" by hiring assistants and retrofitting his or her home. In summary, said Leipzig, five issues should be addressed moving forward: (1)
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From page 9... ...
Kuchel added that there is a need for more information about how and when these changes occur and how they vary due to factors such as sex. Age-related changes in the blood, liver, and kidneys can also impact drug metabolism.
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From page 10... ...
NIH concluded that "participants in trials may not represent real-world populations with these diseases of older adults," said Bernard. In fact, the analysis found that older adults were often excluded from trials altogether; 27 percent of the studies had arbitrary upper age caps, and many studies had exclusion criteria that would indirectly exclude many older 3 Notice of Intent to Revise the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects.
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From page 11... ...
TABLE 2-1 Mean Age of Trial Participants for Select Types of Studies Number of Studies Mean Age (years) Congestive heart failure 45 61.0 ± 9.2 Cardiac dysrhythmias 24 58.0 ± 7.5 Coronary atherosclerosis 106 59.2 ± 6.5 Heart attack 76 58.8 ± 7.0 Stroke 113 53.3 ± 8.3 COPD 14 58.4 ± 7.1 Pneumonia 48 53.4 ± 7.5 Lung cancer 117 52.4 ± 6.0 Prostate cancer 65 65.4 ± 4.6 Osteoarthritis 15 64.6 ± 6.5 NOTE: COPD = chronic obstructive pulmonary disease.
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From page 12... ...
Bernard said that although many trials do not have an official upper or lower age limit, investigators are still "not meaningfully including older adults and children." The workshop helped investigators think about appropriate recruitment policies, inclusion and exclusion criteria, creative ways of configuring study design, and analysis strategies that include all groups. In addition to focusing on age, the workshop emphasized the inclusion of other groups who are traditionally underrepresented in clinical trials, including minority groups, women, and individuals in rural settings.
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From page 13... ...
Forty-five percent of respondents rarely discussed clinical trial participation with their providers, and 39 percent underestimated how long drug development takes. Of the 18 percent of respondents who had previously participated in clinical research, 49 percent reported that it disrupted their daily routine.
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From page 14... ...
Finally, safety can be a big challenge with older adults in clinical trials. There are risks of interactions and adverse drug reactions, and physiological changes related to aging can affect drug metabolism; additionally, participants may also have unrelated underlying diseases that can progress.
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From page 15... ...
, the outcome markers that involve antibody titers do not work well in older adults. Because of these types of differences, Kuchel concluded, it is "absolutely critical" that older adults be included at even the earliest stages of clinical trials.
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From page 16... ...
Making Participation in Clinical Trials Easier Gurwitz asked the presenters to consider ways to make it easier for older adults to participate in clinical trials. For example, he said, investigators might consider meeting participants where they are, such as in nursing homes, rather than requiring participants to travel to the clinical trial investigation site.
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From page 17... ...
INCLUSION OF OLDER ADULTS IN CLINICAL TRIALS 17 cost more money than using a traditional trial site. Bernard added that this approach needs to be "properly funded and properly powered to be able to answer the questions that are being asked." Some analyses have demonstrated that lower cost studies often do not yield outcomes that are as significant as larger, higher cost studies.
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