The doctor's duty to the elderly patient in clinical trials.

Abstract

The ethical principles of beneficence (or non-maleficence), respect for persons and justice apply to both good medical practice and clinical research. Doctors have a duty to offer to their patients, of all ages, the opportunity to take part in clinical trials and to ensure that research is appropriately designed and conducted. Barriers to participation of elderly patients in clinical trials include complex protocols with onerous outcome measures, a research focus on aggressive therapies with substantial toxicity, restrictive entry criteria unnecessarily excluding concurrent conditions and medication, patients' and families' limited expectations of benefits and lack of financial, logistic and social support.Participation is encouraged when attitudes of care staff towards research are positive, altruistic motives are acknowledged, approval of family members is gained and protocols are designed for patient rather than staff convenience. Special consideration should be given to ensuring that patient consent is fully informed and freely given. Elderly patients may have more difficulty comprehending consent information and particular attention should be given to compensating for communication and sensory deficits, improving readability of information sheets and consent forms, and considering the use of innovative consent procedures. Those with cognitive impairment and the institutionalised are vulnerable to exploitation and require special consideration and management.