Historically, age discrimination has existed in clinical trials.1 Although regulatory agencies have promoted the inclusion of older participants in clinical trials since the late 1980’s, the elderly have often been excluded from research trials because of various reasons, including higher co-morbidities and concomitant use of medications.1 Since medications in older patients can produce different responses, it is critical that trials on drugs be performed on patients in the appropriate age group.2 The conclusions formed from studies performed on younger patients cannot be used to determine outcomes for older patients and previous studies have reported an alarming number of trials in which the elderly were excluded unjustifiably from clinical research trials.3 The world population is getting older and cancer occurs more frequently in the elder patient; clearly there is a need to increase the knowledge base regarding care of the older adult with cancer.4 This patient population is at increased risk for toxicity of therapy, although they may derive equal benefit from treatment compared to their younger counterparts.4 Geriatric assessment is critical to capturing the unique differences between chronological age and functional age in the older adult and can help to identify appropriate candidates for cancer therapy.4 Possible barriers to geriatric assessment include the time, resources and expertise needed to obtain the information. These factors are not routinely measured in cancer clinical trials. A recently published study by Hurria et al4 aimed to determine key factors in a geriatric assessment appropriate for prediction of morbidity and mortality in older adults in the cooperative group setting. Patients aged 65 or older with cancer enrolled on cooperative group cancer trials completed a geriatric assessment tool before initiation of protocol therapy. The tool consisted of valid and reliable geriatric assessment measure, was primarily self-administered, and required minimal resources and time from health care providers (HCPs).
The tool measured functional status, comorbidity, cognitive function, psychological state, social support and nutritional status; the key criteria for incorporation of the tool in future cooperative group trials was based on time to completion and the number of patients who could complete the tool without help.
- Out of the 93 patients who enrolled in the study, 85 were assessable
- Median time to completion of the geriatric assessment tool was 22 minutes
- 87% of the patients (n = 74) completed the tool without assistance
- 92% (n = 78) were satisfied with the length of the tool
- 95% (n = 81) reported no difficult questions
- 96% (n = 92) reported no upsetting questions
- 100% of the HCPs completed their section of the tool
The authors of the study concluded that the short, primarily self-administered tool met the criteria for inclusion in future cooperative group clinical trials.4
Cancer is often a disease of the elderly; our population is aging. In order to safely give the most appropriate treatments for this population of patients, clinical trials must include the elderly. Because differences may exist between chronological and functional age, elderly patients must be assessed, however cumbersome or lengthy assessment tools can require extensive time and scant resources limit their use. The authors developed a geriatric assessment tool that could be self-administered without significant intervention from the HCP; this tool was validated and found reliable in the assessment of this population. The geriatric assessment tool could be administered in a relatively short period of time and contributes to the ability to assess older patients at risk for morbidity and mortality; it is commendable that researchers are examining ways to include more elderly patients in clinical trials safely.
- Cherubini, A, Del Signore, S, Ouslander, J et al. Fighting against age discrimination in clinical trials. J Am Geriatr Soc. 2010; 58 (9): 1791-6. doi:10.1111/j.1532-5415.2010.03032.x. Link to abstract at: http://www.ncbi.nlm.nih.gov/pubmed/20863340
- Rehwagen, C. Older people are wrongly excluded from drug trials. BMJ. 2005; 331 (7529): 1360. doi: 10.1136/bmj.331.7529.1360-c Free full text at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1309684/?tool=pubmed
- Bugeja, G, Kumar, A, & Banerjee, AK. Exclusion of elderly people from clinical research: a descriptive study of published reports. BMJ. 1997; 315: 1059. Link to free full text at: http://www.bmj.com/content/315/7115/1059.full
- Hurria, A, Cirrincione, CT, Muss, HB. Implementing a geriatric assessment in Cooperative Group clinical cancer trials: CALBG 360401. J Clin Oncol. 29: 1290-1296. doi:10.1200/JCO.2010.30.6985 Link to abstract at: http://www.ncbi.nlm.nih.gov/pubmed/21357782