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A new report from EFGCP and EUCROF suggests changes to geriatric trials.
Ethics committees should have at least one member with geriatric expertise, and standard operating procedures must include training in geriatric issues. In addition, the SOPs should be subject to audit and inspection. Moreover, there is a strong need to further develop the concepts of consent, assent, and dissent in both pediatric and geriatric clinical trials.
These are some of the key recommendations made in a new report resulting from a joint European Forum for GCP (EFGCP) and European CRO Federation (EUCROF) workshop on ethical challenges in clinical research at both ends of life.
Instead of pushing now for the adoption of a geriatric regulation to mirror the pediatric regulation, the focus should be on creating geriatric expertise at the European Medicines Agency, through networking and possibly a geriatric committee, according to the report. Also, the "normal" upper age of adulthood (i.e., the start of "elderhood") as laid down by the EMA should increase from 65 to 75. The report goes on to suggest that there should be a public debate, as well as education about the need for research in elderly people.
It is still too early to evaluate the success of the pediatric regulation, but pediatricians seem very positive about its effect on promoting research in children. The burden on the industry is recognized by the authors of the report, however, further work is required to assess the consistency of decisions on proposals for pediatric investigations.
Many of the areas of ethical concern in pediatrics are shared in geriatrics, but children tend to gain capacity to understand the implications of taking part in research, whereas adults tend to lose it as they grow older. The report notes that it is wrong, however, to start from an assumption that older people necessarily lack capacity to consent to taking part in research.
In the report, Martine Dehlinger-Kremer, PhD, head of the EUCROF's pediatric working group and Vice President of Global Regulatory Affairs at Omnicare Clinical Research in Germany, notes that recent experiences in the field of pediatric research will help experts to develop guidance or regulations for geriatrics. She fears that the requirements of elderly people may lead to multiple, long, and expensive studies that may not always be feasible before authorization.
Observational data, including follow-up of a sample of frail elderly people, may be an option in the framework of post-authorization commitments as part of the risk management plan.
"For the future, we need to work towards systematically requiring the appraisal of exposing elderly people to drugs as appropriate, and the standardization of findings in the CHMP (Committee for Medicinal Products for Human Use) assessment report and its summary of product characteristics," Dehlinger-Kremer said.
The EFGCP's Ingrid Klingmann, MD, from Pharmaplex in Belgium, said she is usually an optimist, but she has strong doubts whether extending the current paradigm of drug development to an older age group will improve the overall drug development process. Requesting mandatory trials with older people for the marketing authorization dossier would make drug development more expensive and time-consuming, she stated. For Klingmann, the solution is to support a public debate about the geriatric research.
"Unless we raise this public debate, we won't be able to motivate the researchers," she said.
The EFGCP/EUCROF workshop was held in Antwerp, Belgium, on April 27 to April 28, 2010.—Philip Ward
Editor's Note: Philip Ward previously wrote about the need for increased participation of the elderly in clinical trials in a report last year. http://appliedclinicaltrialsonline.findpharma.com/elderly.