Do we protect or discriminate? Representation of senior adults in clinical trials

Rep Pract Oncol Radiother. 2012 Sep 26;18(1):6-10. doi: 10.1016/j.rpor.2012.08.006. eCollection 2012.

Abstract

Aim: The analysis of barriers responsible for low recruitment of older patients in clinical trials and presentation of possible solutions are the subject of this review.

Background: Europe's population is ageing, and the group of people who more frequently develop neoplasms increases. Oncologists are confronted with a new challenge - how to treat cancer in this group of patients, especially considering the lack of Evidence Based Medicine (EBM) guidelines for treatment of cancer in the elderly population.

Materials and methods: Medline search and analysis of studies published between 1999 and 2012, containing key words: senior adults, cancer, elderly in clinical trials.

Results: Detailed analysis of relevant studies demonstrated that senior adults are underrepresented in clinical trials. Moreover, there is a lack of trials exclusively designed for this heterogeneous group of patients. The analysis of reasons for low recruitment of older patients in clinical trials revealed barriers dependent on patient's and physician's attitudes as well as institutional and logistic problems.

Conclusions: It is necessary to widen the scale of trials of all phases in the group of seniors with appropriate assessment of toxicity. This will allow a proper stratification and obtaining representative groups for statistical analysis and credible trial results. Another priority is the design of trials dedicated exclusively to the elderly.

Keywords: Cancer; Elderly in clinical trials; Senior adults.