Clinical trials involve the systematic investigation of new treatments, interventions, or drugs in human subjects to determine their safety, efficacy, and potential side effects. The clinical trials involve healthy adult population as well as diseased patients to evaluate therapeutic safety and efficacy of the pharmacological agent under investigations. Elderly subjects 65 years and above are usually not considered as study participants in the clinical trials unless the investigation medicine is especially intended for subjects above 65 years. Thus, the medicines meant for elderly adults are addressed as << geriatric medicine>> and the subject population are addressed as elderly adults or geriatric population. Thus individuals who are elderly or of advanced age, typically 65 years old and above constitute as << special population>> and clinical trials in such subjects are called <<clinical trials in special population/ geriatric population>>.
Including the geriatric population in clinical trials is challenging as they present diverse health conditions and their response to medical interventions may differ from that of young adults. Key considerations involving the geriatric population in clinical trials include diversity within the geriatric population, prevalence of comorbidities, taking multiple medications simultaneously (polypharmacy), cognitive function, ability to perform daily activities independently, safety and tolerability of interventions and general health status.
Involving the geriatric population in clinical trials requires careful consideration of ethical principles to ensure the well-being, autonomy, and rights of the participants. Involving geriatric population must be considered only when the research question is predominantly present and prevalent in geriatrics and the intervention is intended for the same. There should also be reasonable justification that involving young adults may not yield the correct results and therefore justifies including elderly adults in the clinical research program. Based on this premise, clinical study among geriatrics can be planned and involve key ethical considerations as listed below:
- Informed Consent:
- Ensuring that participants have the capacity to provide informed consent. Recognizing that cognitive impairment may be more prevalent in the geriatric population, and additional measures may be needed to assess and support understanding.
- Providing information in a clear and understandable manner, using appropriate communication tools and, if necessary, involving family members or legal representatives in the decision-making process.
- Benefit and Risk Assessment:
- Evaluating the potential benefits and risks of the research for the geriatric population. Considering the balance between the potential benefits of the research and the risks associated with participation, taking into account the vulnerabilities and health conditions commonly found in this age group.
- Representation:
- Striving for a representative sample of the geriatric population in clinical trials to ensure that study results are applicable to a broad range of individuals within this demographic. Be mindful of including diverse subpopulations, considering factors such as ethnicity, socioeconomic status, and health conditions.
- Minimization of Burden:
- Minimizing the burden on participants, considering factors such as the frequency and duration of study visits, as well as the complexity of study procedures. Acknowledging the potential challenges and limitations associated with age-related conditions.
- Monitoring and Safety:
- Implementing robust monitoring and safety measures, including regular health assessments, to promptly identify and address any adverse events. Geriatric participants may be more susceptible to certain adverse effects, so it is crucial to monitor their well-being closely.
- Respect for Autonomy:
- Respecting the autonomy of geriatric participants by involving them in decision-making processes related to their participation in the trial. Consider their preferences, values, and priorities, and allowing them to withdraw from the study at any point without facing negative consequences.
- Social Support:
- Recognizing the importance of social support for geriatric participants. Encourage the involvement of family members or caregivers in the research process, where appropriate, to provide emotional and practical support.
- Long-term Follow-up:
- Designing studies with long-term follow-up to assess the impact of interventions on the geriatric population over time. This is particularly important for chronic conditions that may manifest or progress slowly.
- Transparency and Communication:
- Maintaining transparent communication with geriatric participants throughout the trial, providing updates on the progress of the study and any relevant findings. Fostering a sense of partnership and trust between researchers and participants.
- Ethical Review:
- Ensuring that research involving the geriatric population undergoes thorough ethical review by institutional review boards or ethics committees. These committees should include members with expertise in geriatrics to adequately evaluate the ethical implications of the study.
In summary, geriatric population should be considered for a clinical trial only when the intended medical condition is predominantly prevalent in geriatric population and the investigational medicinal product is an unmet need for the same. Thus the ethical considerations in clinical trials involving the geriatric population are critical to protect the rights, well-being, and dignity of older participants, and to ensure the essentiality, validity and applicability of research findings to this demographic group. Adhering to ethical principles contributes to the responsible and respectful conduct of research involving older individuals.
