Systematic exploration of novel treatments, interventions, or medications in humans are a part of the clinical trials for determination of their efficacy, safety, and probable side effects. The populace of clinical trials is comprised of adults belonging to a healthy population and also participants with underlying diseases for evaluation of the efficacy and safety of the pharmacological drug being investigated. 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. Geriatric population should never be exposed to any safety concerns and/ or health risks by participation in any research programs.
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 justify 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. Since, it has been identified that there is a prevalence of cognitive impairment in the aged population, extra actions might be required to evaluate and aid in understanding.
- Ensuring that information is provided in a transparent and logical style, with the help of necessary tools for communication and, if needed, making the members of the family or authorized representatives in the process of making decisions.
- Assessment of Benefit and Risk:
- Evaluates the geriatric populace’s possible research benefits and risks by striking a balance between both, considering the weaknesses and conditions of health found in common in this particular age group.
- Representation:
- Trying to fit in a wide demographic range within this sample populace for conducting the trials including varied subpopulations, ethnicity considerations, status of social class, and conditions of health.
- Minimization of Burden:
- The load on the participants is reduced by keeping certain factors in mind like reducing the regularity and extent of visits to the study sites along with the complex nature of the procedures of the study. Also, acknowledgement of the prospective challenges and restrictions have to be kept in mind due to the age-related circumstances.
- 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 allow them to withdraw from the study at any point without facing negative consequences.
- Social Support:
- Participants belonging to the geriatric population should be provided with social, practical, and emotional support by encouraging the contribution of members of their family or caretakers in the process of research, wherever necessary.
- Follow-up for a Long-term:
- The studies should be designed for long term and periodic follow up to determine the interventions impact time to time on the geriatric populace. These follow-ups are relatively necessary for chronic disorders that might show up or slowly progress.
- Transparency and Communication:
- A sense of faith and partnership is maintained throughout the process of trial between the researchers and the participants by delivering study’s progress updates and any other important findings.
- Ethical Review:
- It must be ensured that the study encompassing the geriatric populace goes detailed ethical review by committees of ethics or institutional review boards having expert members in geriatrics to effectively assess the study’s consequences ethically.
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.
