Differences between unselected patients and participants in multiple myeloma clinical trials in US: a threat to external validity
Abstract
External validity of clinical trials is affected by dissimilarities between study subjects and patient population. We identified 128 manuscripts (8,869 subjects) published between 2007 and 2014 reporting results of multiple myeloma (MM) trials performed entirely in the US. Characteristics of subjects were compared with unselected patients from SEER-18. Median of median age of subjects was 61 years vs. median age of unselected patients of 69 years. Trial subjects with untreated MM had less advanced stage than unselected patients. Racial-ethnic composition was informed in only 51 (39.8%) trials. Industry-sponsored trials were more likely to report accrual of minorities than National Cancer Institute (NCI) or investigator-sponsored trials. The observed/expected minority accrual was 0.52 (95% CI 0.49-0.55), being lower (0.43) in investigator-sponsored and higher (0.61) in industry-sponsored trials. We concluded that minorities, older individuals and persons with more advanced disease are underrepresented in MM trials, potentially compromising external validity of results.
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Language barriers, primarily where English was not the first spoken language, was a major barrier for Hispanic and Latin American trial participation.
“Studies also highlighted that language barriers, primarily where English was not the first spoken language, was a major barrier for Hispanic and Latin American trial participation [69].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [69]
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- Authors
- Costa, L. J., Hari, P. N., & Kumar, S. K.
- Affiliations
- University of Alabama at Birmingham (US)
- Medical College of Wisconsin (US)
- Mayo Clinic (US)
- Corresponding author
- Costa, Luciano J.
- Venue
- Leukemia & Lymphoma
- Publisher
- Informa UK Limited
- Published
- 2016-04-22
- Volume
- 57
- Issue
- 12
- Pages
- 2827-2832
- ISSN
- 1026-8022 (ISSN-L)
- 1042-8194
- 1029-2403
- OpenAlex
- W2341043824
- Cited by
- 57
- References
- 17
- Citations by year
- 2025: 2 · 2024: 4 · 2023: 1 · 2022: 8 · 2021: 12 · 2020: 11 · 2019: 4 · 2018: 5 · 2017: 7 · 2016: 2
- FWCI
- 5.70
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Leukemia & lymphoma/Leukemia and lymphoma (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Heart, Lung, and Blood Institute (UG1HL138641)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- multiple myeloma, underrepresentation of minorities, elderly patients, disease stage, industry-sponsored trials, SEER, patient accrual
- MeSH terms
- Adult, Age Factors, Aged, Aged, 80 and over, Clinical Trials as Topic, Ethnicity, Female, Humans, Male, Middle Aged, Multiple Myeloma, Sex Factors, United States, Reproducibility of Results, SEER Program, Patient Selection
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