The aim of this assessment task is to enable you to explore ethical principles related to human research, specifically the complexities of treatment benefits versus biomedical ethical considerations.

Introduction

The Alzheimer's disease Anti-inflammatory Prevention Trial (ADAPT) organised and conducted by the ADAPT research group focussed on evaluating the therapeutic significance of NSAIDs. Drugs like celecoxib and naproxen were evaluated for preventing the onset and establishment of AD (Alzheimer’s dementia) among elderly individuals (ADAPT_Research_Group, 2006). The elderly patients attributing to the age of 70 years and older were selected for the research intervention while considering their family history of Alzheimer's dementia. The study was planned for seven long years. The study findings indicated a statistically insignificant influence of celecoxib or naproxen on the death rates of the elderly subjects who continued to receive them with the objective of preventing the acquisition of AD and associated clinical manifestations. The findings of this research study appeared relevant because of the randomisation of treatment arms for reducing the scope of biased findings. Randomisation techniques prove effective for the systematic reduction in confounding factors and associated bias and inadequacies in the treatment allocation (Suresh, 2011). The research trial was conducted on a wider scale; however, the findings remained questionable due to the confined safety analysis. The study findings in (ADAPT_Research_Group, 2006) provided evidence related to the pattern of cardiovascular harms that the selected NSAIDs might induce in the elderly patients who experience the elevated risk of acquiring AD across the community environment. The study raises ethical concerns regarding the requirements of its early termination or extension for the benefit of AD patients.

Researchers’ decision of early termination of the study

The ADAPT research group decided early termination of the study intervention in the context of cardiovascular health risks of the study participants. However, the study findings proved inconclusive in terms of assessing the health adversities and deaths experienced by the participants while utilising naproxen and celecoxib in accordance with the treatment protocol. The ethical conventions emphasised by (Wharam&Lazarou, 2013) advocate the requirement of preventing the health and wellness of people in the present scenario in comparison to the reduction of their prospective health risks and associated disease outcomes. This might be the preliminary cause of halting the duration of ADAPT by the research investigators and coordinators. Contrarily, their decision of reducing the length of the study appeared ethically biased to a limited extent. This ethical biasing is revealed by the fact that the early termination of study intervention occurred in the absence of substantial real-time cardiovascular adversities encountered (under the influence of the administered NSAIDs) during the trial process. The objective of this clinical trial attributed to the maximisation of the mental and behavioural health benefits of the elderly population. However, mental health enhancement of the elderly population at risk of their cardiovascular health deterioration restrained study coordinators in continuing the trial intervention for the pre-scheduled span of seven years. The policies, practices and value-based ethical conventions related to pharmacy interventions are not well-defined in the evidence-based research literature (Salari, et al., 2013). This probably became another cause of the circumstantial decision of the ADAPT team in terms of reducing the length of the clinical trial. Ethics related to the medication intervention under the influence of patients’ health risks require the systematic undertaking of calculated decisions by the research community for effectively minimising the probability of harm to the treated patients. The beneficence of the study participants remains the priority of the study investigators, and therefore, the requirement of preserving the existing health of the enrolled subjects effectively overweighs the prospective health benefits that the study findings might generate for the future populations (Salari, et al., 2013). These evidence-based facts substantially validate the requirement of halting ADAPT intervention by the research team. The ADAPT approach did not utilise counterfactual strategies over an extended tenure with the objective of evaluating the predisposition of the study participants in terms of acquiring cardiovascular and cerebrovascular co-morbid states and associated mortalities in the absence of naproxen and celecoxib administration. Therefore, the study findings do not rationally elucidate the influence of interferences, including the age of subjects, their family history of AD and aspirin administration on the pattern of their cardiovascular and cerebrovascular adversities observed during the trial intervention. This indicates that the randomisation of the trial subjects in the absence of the long-term counterfactual assessment of the study approaches leads to the generation of questionable findings. With these perspectives in hand, the ADAPT intervention resulted in a weak conclusion regarding the safety issues pertaining to the administration of naproxen and celecoxib in the elderly subjects (Nardini, 2014). Research analysis by (Lipworth&Kerridge, 2013) reveals the requirement of administering the medication interventions to the clinical subjects for promoting the establishment of non-maleficent and beneficent healthcare systems across the community environment. The therapeutic regimen, as well as care of the research subjects, requires the implementation of the conventions related to patient’s autonomy, justice, veracity and confidentiality. The ADAPT research team subjectively followed the same ethical theme while terminating the study intervention before the stipulated timeline. However, the ethical appropriateness of this evidence-based decision remains a controversial subject that might guide the research professionals in organising prospective clinical trials in the context of attaining the beneficial outcomes of NSAIDs for elderly patients. Evidence-based research literature advocates the requirement of thoroughly attaining the information related to the prescription management, pharmacokinetics and pharmacodynamics of the AD prophylaxis drugs in the context of statistically analysing the risk of adverse events and associated fatalities among the treated subjects (Lowenthal, Hull, & Pearson, 2012). The ADAPT research team did not acquire the desired knowledge of the safety profile of naproxen and celecoxib prior to initiating their clinical trial. The research team could have organised the trial in two distinct phases for reducing the scope of its early termination. The first stage could analyse the safety parameters, and the second stage (related to AD prophylaxis) might follow the initial stage after its successful accomplishment. Indeed, the absence of careful planning of the ADAPT intervention proved to be another significant reason of its early termination by the research professionals.

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