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]
]. 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]
]. Cancer incidence in the over 65 years category is expected to increase dramatically by 67% from 2010 to 2030 [
[3]
]. 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]
].To read this article in full you will need to make a payment
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References
- Studies in support of special populations: geriatrics.(1994 20/12/2016]; Available from: Available at)
- 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
- Committee for Medicinal Products for Human Use. Adequacy of guidance on the elderly regarding medicinal products for human use.(2006 20/12/2016]; Available from: Available at)
- Studies in support of special populations: geriatrics questions and answers.(2010 20/12/2016]; Available from: Available from:)
- The European Medicines Agency's geriatric medicines strategy.(2011 20/12/2016]; Available from: Available from)
- Overall survival in cancer drug trials as a new surrogate end point for overall survival in the real world.JAMA Oncol. 2016;
- Barriers to clinical trial participation by older women with breast cancer.J Clin Oncol. 2003; 21: 2268-2275
- Introducing Cochrane Global Ageing: towards a new era of evidence [editorial].Cochrane Database Syst Rev. 2016; 9
- The real-world evidence of heart failure: findings from 41 413 patients of the ARNO database.Eur J Heart Fail. 2016; 18: 402-410
- Pharmacology of anticancer drugs in the elderly population.Clin Pharmacokinet. 2003; 42: 1213-1242
Article info
Publication history
Published online: March 08, 2017
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© 2017 Elsevier Ltd. All rights reserved.
