Literature DB >> 32611268

Age demographics of subjects enrolled in interventional phase 3 multiple myeloma clinical trials.

Abhilasha Borad1,2, Hamnah Saeed1, Michael Toscani1, Joseph Barone1, Paul Weber1,2.   

Abstract

The mean and median ages of diagnosis of multiple myeloma range from 70 to 73 years old, with 63% of patients being over the age of 65. Phase 3 clinical trials are designed to study efficacy in the target disease population and are meant to have the most representative subject pool. The purpose of this review is to identify the age demographic of subjects participating in interventional phase 3 clinical trials that aim to treat multiple myeloma and to determine if they encompass the true age demographic of the disease. To complete this review, a search of phase 3 multiple myeloma research trials with reported results was conducted on clinicaltrials.gov, a national, publicly available resource listing clinical trials. Reported mean or median ages of subjects were identified for each trial, and adjusted averages of these values were calculated. Data from 81 clinical trials were assessed, with 42 trials reporting an average mean age of 65.78 years and 15 trials reporting an average median age of 63.29 years. Based on these results, it was determined that the clinical trials reported in this study enrolled patients that were younger than the true age demographic of the disease. There is an unmet need in research in the older population of patients with multiple myeloma, and this may hinder the generalizability and utility of clinical trial results.

Entities:  

Keywords:  Multiple myeloma; age demographics; clinical trial design; geriatric oncology; trial participants

Mesh:

Year:  2020        PMID: 32611268     DOI: 10.1177/1078155220934162

Source DB:  PubMed          Journal:  J Oncol Pharm Pract        ISSN: 1078-1552            Impact factor:   1.809


  1 in total

Review 1.  Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials.

Authors:  Reema Shah; Nil Patel; Yasha Patel; Michael Toscani; Joseph Barone; Paul F Weber
Journal:  Ther Innov Regul Sci       Date:  2022-01-09       Impact factor: 1.778

  1 in total

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