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” [
]. 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% [
- ICH Topic E7
Studies in support of special populations: geriatrics.
]. Cancer incidence in the over 65 years category is expected to increase dramatically by 67% from 2010 to 2030 [
- 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
]. 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 [
- 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
- 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
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- Studies in support of special populations: geriatrics.(1994 20/12/2016]; Available from: Available at)www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500002875&mid=WC0b01ac058009a3dc
- Under-representation of older adults in cancer registration trials: known problem, little progress.J Clin Oncol. 2012; 30: 2036-2038
- Future of cancer incidence in the United States: burdens upon an aging, changing nation.J Clin Oncol. 2009; 27: 2758-2765
- The PREDICT (increasing the participation of the elderly in clinical trials) study: the charter and beyond.Expert Rev Clin Pharmacol. 2014; 7: 457-468
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Published online: March 08, 2017
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