The International Conference of Harmonisation (ICH) E7 efficacy guideline “Studies in support of special populations: geriatrics” was adopted in 1993 by the regulatory bodies of Europe, USA and Japan, stating that “a minimum of 100 patients would usually allow detection of clinically important differences” and that “it is also important not to exclude unnecessarily patients with concomitant illness” [ [1] ICH Topic E7 Studies in support of special populations: geriatrics. www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500002875&mid=WC0b01ac058009a3dc Google Scholar ]. Since then, the world's population has been aging rapidly: in the United States, the percentages of patients with cancer who are older than 65, 70 and 75 years are, respectively, 60%, 46% and 31% [ [2] Scher K.S. Hurria A. Under-representation of older adults in cancer registration trials: known problem, little progress. J Clin Oncol. 2012; 30: 2036-2038 Crossref PubMed Scopus (274) Google Scholar ]. Cancer incidence in the over 65 years category is expected to increase dramatically by 67% from 2010 to 2030 [ [3] Smith B.D. et al. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009; 27: 2758-2765 Crossref PubMed Scopus (1314) Google Scholar ]. Restrictive eligibility criteria such as arbitrary upper age limits or exclusion criteria based on comorbidities, polypharmacy or reduced life expectancy, have resulted in the exclusion of older people from clinical trials [ [4] Crome P. Cherubini A. Oristrell J. The PREDICT (increasing the participation of the elderly in clinical trials) study: the charter and beyond. Expert Rev Clin Pharmacol. 2014; 7: 457-468 Crossref PubMed Scopus (34) Google Scholar ].
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Raimi‐Abraham et al. (2017) studied this question.