Guidance synthesis. Medical research for and with older people in Europe: Proposed ethical guidance for good clinical practice: Ethical considerations
ABSTRACT Introduction: In Europe the population is ageing rapidly. Older people are taking many medicinal products daily and these may not necessarily be suitable for them. Publications show that older patients are underrepresented in clinical trials, especially those over 75 years, with multiple co-morbidities, concomitant treatments and/or frailty. This document provides a summary of recommendations on ethical aspects of clinical trials with older people, who may in some cases be considered a vulnerable patient population. The EFGCP's Geriatric Medicine Working Party (GMWP) has developed this guidance to promote such research and to support health care professionals in their efforts. Ethical, scope and context: The definition of a geriatric patient is reviewed. Frail and vulnerable patients, who are a minority of geriatric patients, should be included whenever it is relevant. The legal context is described. The process of informed consent: All adults should be presumed capable of consent, unless proven otherwise; informed consent must be sought for all older people who are able to consent. A simple, short and easy-to-understand information sheet and consent form will contribute to improving the readability and understanding of the older participant. A participant guide and the use of a simple tool to ensure decision making capacity, are recommended. Whenever older people are unable to consent, their assent should be sought systematically using adequate information, in addition to seeking the consent of their legal or authorised representative as appropriate. Ethics Committees: Research ethics committees need internal and/or external geriatric expertise to balance the benefits and risks of research in older people and to appreciate and recognise their autonomy. Design and Analyses: Design and Analyses should be adapted to the objectives with appropriate outcomes and are not different from other clinical trials. Conclusions: The absence of proper recruitment or insufficient presence of older patients in clinical development plans for new medicinal products is detrimental; there is a need to improve evidence-based knowledge, understanding and management of their conditions and treatment. The aim of this guidance is to facilitate clinical research for and with the older patient population. The long version of the guidance will be available on the EFGCP's website: www.efgcp.be/.
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ABSTRACT: Elderly subjects are still poorly represented in clinical trials, because of unjustified upper age limits. The prejudged reluctance of elderly patients to participate in trials could also be a barrier to their inclusion. The objective of this pilot study was to clarify the position of elderly subjects on their motivations and the reasons for their ultimate refusal to participate in clinical trials. A questionnaire survey was administered to 150 elderly subjects, aged 70 years or over, living at home, in long-term care units, or hospitalized. Only 44 % of the sample population answered that they would agree to participate in a trial that afforded personal benefit. These results did not depend on age but rather on health condition and sex. Motivations were mostly altruistic rather than based on personal concerns. The main reasons for refusal were fear that the experiment could damage their health and that they thought they were too old. Elderly subjects are not inclined to participate in clinical trials. In the future, we should aim to increase the information on clinical trials for older patients and train researchers appropriately if we wish to increase the participation levels of this age group in such trials. More research is needed on a larger sample.Drugs & Aging 03/2014; DOI:10.1007/s40266-014-0168-2 · 2.50 Impact Factor
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ABSTRACT: To examine how target patients seen in clinical practice are represented in clinical trials for approved drugs in Japan, we compared the age distribution of older patients enrolled in confirmatory clinical trials for regulatory approval with that of the estimated actual patient population. Drugs for 6 chronic conditions common among older patients (diabetes mellitus, hypertension, rheumatoid arthritis, non-small cell lung cancer, depression and Alzheimer's disease) launched by 2012 in Japan were selected. The disparity in age distribution between patients in trials and patients seen in clinical practice varied depending on the disease, but older patients, especially those aged 75 or older, were generally underrepresented in clinical trials for regulatory approval in Japan. Under-representation of older patients in hypertension trials was particularly marked compared to other conditions, despite the similarity in age distribution of patients seen in clinical practice. One factor causing this disparity may be an upper age limit in clinical trial protocols. More effort is needed to properly characterize the benefits and risks of drugs for older patients. This should include the active enrollment of older patients in clinical trials, the establishment of better assessment tools such as pharmacometric approaches, and the appropriate planning and conducting of post-marketing surveys and studies.The Journal of Nutrition Health and Aging 05/2014; 18(5):520-523. DOI:10.1007/s12603-014-0031-5 · 2.66 Impact Factor
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ABSTRACT: Objectives To investigate the inclusion of older people in clinical trials of recently authorized medicines, evaluating adherence to the 20-year-old International Conference of Harmonisation (ICH) guideline on geriatrics (E7). DesignObservational. SettingEuropean public assessment reports, published clinical trials, World Health Organization International Clinical Trials Registry Platform. ParticipantsIndividuals aged 65 and older and 75 and older. MeasurementsNumber and proportion of randomized participants and all exclusion criteria of studies involving diseases characteristically associated with aging (venous thromboembolism, osteoporosis, atrial fibrillation) and diseases not unique to older adults (type 2 diabetes mellitus, depression, bipolar disorder, epilepsy). ResultsIn 114 Phase II and III trials of 12 medicines, 43.1% of participants were aged 65 and older, and 16.1% were aged 75 and older. In trials involving diseases characteristically associated with ageing, 57% were aged 65 and older; 22% were aged 75 and older. In trials involving diseases not unique to old age, 9% were aged 65 and older, and 1% were aged 75 and older. Upper age limits were applied in 30.7% of the trials; the frequency did not differ between larger (sample size 500) and smaller trials (P=.36), although it was significantly lower in trials involving diseases characteristically associated with aging (18.0%) than in trials of diseases not unique to old age (45.3%; P=.002). Age-sensitive exclusion criteria, based on comorbidity (75.4%), concomitant medication (71.9%), and other criteria correlated with age (60.5%) were applied more frequently in larger trials (P<.02). Conclusion Studies of diseases not uniquely associated with old age included an unacceptably low proportion of older people, contrary to the recommendations of the ICH E7 guideline. Although the proportion of older participants in trials of diseases characteristically associated with aging was appropriate for certain medicines, the use of age-sensitive exclusion criteria limits the representativeness of the trial population for daily practice.Journal of the American Geriatrics Society 10/2014; 62(10). DOI:10.1111/jgs.13067 · 4.22 Impact Factor