Clinical Trials
This article was originally published in SRA
Executive Summary
US watchdog finds elderly underrepresented in US drug studies
US watchdog finds elderly underrepresented in US drug studies
A report from the US Government Accountability Office has criticised the Food and Drug Administration for failing to ensure that elderly people are sufficiently represented in clinical trials1,2.
The report examined 36 new drug applications filed with the FDA between January 2001 and June 2004. It found that while all 36 NDAs had at least one clinical trial that included some elderly participants, 13 had clinical trials with exclusion criteria prohibiting the participation of at least some elderly persons on the basis of age alone. Three of the 13 had a trial which excluded anyone over 65.
Senator Edward Kennedy (Democrat - Massachusetts) requested the GAO report along with Representative Henry Waxman (Democrat - California), chairman of the House Committee on Oversight and Government Reform. “Seniors use more drugs than any other age group, but they are not getting enough attention in the drug approval process,” Representative Waxman said. “FDA medical officers need to do a better job assessing the safety and effectiveness of drugs in older populations,” he said.
FDA guidance is criticised for failing to make clear important requirements in the drug evaluation process for elderly people. The report notes, for example, that guidance does not direct medical officers to determine whether there were enough elderly participants in trials to assess the safety and effectiveness for elderly people of the drug in question. Sufficiency of representation, the report said, is referred to in guidance using broad terms such as “age” or “demographic subgroups”; specific ages or accurate terms such as “elderly” are not used. Only around one-quarter of the review summaries examined in the report documented medical officers' review of whether elderly patients had sufficient representation in trials.
In response, the Department of Health and Human Services emphasised that its guidance on clinical safety review specifically asks whether adequate numbers of various demographic subjects are represented in clinical trials and whether patients excluded from the study limited the relevance of safety assessments. Age is always considered to be an important demographic subgroup, the HHS said, even if it is not explicitly stated in guidance to reviewers. References to “age” are implicit references to the elderly, it said, with regard to the content of the clinical safety review guidance and specific documents on geriatrics such as the Guideline for the Study of Drugs Likely to be Used in the Elderly.
References
1. House Committee on Oversight and Government Reform press release, 29 October 2007, http://oversight.house.gov/documents/20071029131600.pdf
2. GAO report, 28 September 2007, http://oversight.house.gov/documents/20071029120758.pdf