Are older adults insufficiently included in clinical trials?—An umbrella review

Treatment guidelines are primarily based on randomized clinical trials (RCTs). RCTs tend to some extent to exclude older adults despite the fact that physicians need guidance when treating this patient group. By summarizing existing literature, we aimed to (a) quantify the proportion of RCTs and oth...

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Bibliographic Details
Published in:Basic & clinical pharmacology & toxicology 2021-02, Vol.128 (2), p.213-223
Main Authors: Florisson, Sandra, Aagesen, Emilie Kørschen, Bertelsen, Ann Sophia, Nielsen, Lars Peter, Rosholm, Jens‐Ulrik
Format: Article
Language:English
Subjects:
Adults
Age Factors
Aged
Aged, 80 and over
Clinical trials
Criteria
drug discovery and development
Female
gerontopharmacology
good clinical practice
Humans
Male
Older people
Patient Selection
pharmacoepidemiology
Physicians
Quality assessment
Quality control
randomized controlled trial
Randomized Controlled Trials as Topic
Research Subjects
risk assessment
safety pharmacology
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Summary:Treatment guidelines are primarily based on randomized clinical trials (RCTs). RCTs tend to some extent to exclude older adults despite the fact that physicians need guidance when treating this patient group. By summarizing existing literature, we aimed to (a) quantify the proportion of RCTs and other clinical studies (CTs) that did not adequately include older adults; (b) identify the main barriers for this non‐inclusion; and (c) identify suggested solution for inclusion of older adults in RCTs and other CTs. In this umbrella review, Embase and PubMed were searched for relevant papers, and 2701 papers were identified. The subsequent screening resulted in 22 papers. The Critical Appraisal Skills Program was used as quality assessment tool to evaluate these 22 papers. We found that: (a) The most frequent outcome designating missing inclusion of older adults was the use of age limit as exclusion criterion in studies—the proportion of this was 10%‐60%; (b) barriers for inclusion were mainly exclusion criteria, logistic challenges and financial constraints; and (c) more extensive inclusion would require more explicit inclusion criteria, merely application of exclusion criteria when absolutely needed, change of researchers’ attitude, further inclusion of supporting relatives to overcome the logistical challenges and more financial funding.
ISSN:1742-7835
1742-7843
1742-7843
DOI:10.1111/bcpt.13536