Hanlon, P. , Hannigan, L. , Rodriguez-Perez, J., Fischbacher, C., Welton, N. J., Dias, S., Mair, F. S. , Guthrie, B., Wild, S. and McAllister, D. (2019) Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis. BMC Medicine, 17, 201. (doi: 10.1186/s12916-019-1427-1) (PMID:31711480) (PMCID:PMC6849229)
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Abstract
Background: Clinicians are less likely to prescribe guideline-recommended treatments to people with multimorbidity than to people with a single condition. Doubts as to the applicability of clinical trials of drug treatments (the gold standard for evidence-based medicine) when people have co-existing diseases (comorbidity) may underlie this apparent reluctance. Therefore, for a range of index conditions, we measured the comorbidity among participants in clinical trials of novel drug therapies and compared this to the comorbidity among patients in the community. Methods: Data from industry-sponsored phase 3/4 multicentre trials of novel drug therapies for chronic medical conditions were identified from two repositories: Clinical Study Data Request and the Yale University Open Data Access project. We identified 116 trials (n = 122,969 participants) for 22 index conditions. Community patients were identified from a nationally representative sample of 2.3 million patients in Wales, UK. Twenty-one comorbidities were identified from medication use based on pre-specified definitions. We assessed the prevalence of each comorbidity and the total number of comorbidities (level of multimorbidity), for each trial and in community patients. Results: In the trials, the commonest comorbidities in order of declining prevalence were chronic pain, cardiovascular disease, arthritis, affective disorders, acid-related disorders, asthma/COPD and diabetes. These conditions were also common in community-based patients. Mean comorbidity count for trial participants was approximately half that seen in community-based patients. Nonetheless, a substantial proportion of trial participants had a high degree of multimorbidity. For example, in asthma and psoriasis trials, 10–15% of participants had ≥ 3 conditions overall, while in osteoporosis and chronic obstructive pulmonary disease trials 40–60% of participants had ≥ 3 conditions overall. Conclusions: Comorbidity and multimorbidity are less common in trials than in community populations with the same index condition. Comorbidity and multimorbidity are, nevertheless, common in trials. This suggests that standard, industry-funded clinical trials are an underused resource for investigating treatment effects in people with comorbidity and multimorbidity.
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | McAllister, Professor David and Mair, Professor Frances and Hannigan, Dr Laurie and Hanlon, Dr Peter |
| Authors: | Hanlon, P., Hannigan, L., Rodriguez-Perez, J., Fischbacher, C., Welton, N. J., Dias, S., Mair, F. S., Guthrie, B., Wild, S., and McAllister, D. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health |
| Journal Name: | BMC Medicine |
| Publisher: | BMC |
| ISSN: | 1741-7015 |
| ISSN (Online): | 1741-7015 |
| Published Online: | 12 November 2019 |
| Copyright Holders: | Copyright © The Authors 2019 |
| First Published: | First published in BMC Medicine |
| Publisher Policy: | Reproduced under a Creative Commons license |
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