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Ethical Considerations in Clinical Trials

A a double-blind, randomized, controlled trial involving 2246 symptomatic, nonhospitalised and unvaccinated adults was conducted by Hammond et al. (2022) where the efficacy, safety, and viral load of nirmatrelvir and ritonavir was evaluated. Briefly, patients went randomisation whereby 1120 and 1126 were placed in a treatment or placebo group respectively. Appropriate doses were administered every 12 hours for 5 days. The results of this phase 2-3 trial suggested that nirmatrevir treatment significantly reduced the risk of COVID-19 related death or hospitalisation by 89.1% (p<0.001). I believe this clinical trial followed ethical standards. Clinical testing was done ethically as all participants were required to undergo a screening process, provide informed consent, and were given full freedom to withdraw from the trial. This process insured that the research is targeted to its objectives and aims of reducing progression of severe disease and hospitalisation amongst the unvaccinated whilst ensuring minimal additional harm to the patients. To ensure all participants had a sufficient maturity to express their decision on being involved and understand the crucial details of the trial, only those above 18 years of age were accepted. Additionally, an ethics committee approved the trial at each of the 202 trial sites and the trial was designed in accordance with international ethical standards to allow all countries to acknowledge the work. Unfortunately, there were 13 deaths in the placebo group. This presents as an ethical issue, because these patients should have exited the trial and be given standardised medical treatment. Despite this, the patients have given informed consent and due to the vast scale of this trial; some deaths were to be expected especially when only unvaccinated people with serious health issues were included. The global need of effective prophylactic COVID-19 antivirals justifies these unfortunate deaths (Kunal et al., 2022). The company 'Pfizer' was responsible for all major parts of this trial including data analysis and interpretation. Thus, there is a concern that the results may have been exaggerated. However, an external data monitoring committee reviewed the trial and all aspects of data analysis to ensure that there is full commitment to the truth. Also, all the authors insured that the data was shared to everyone by means to maintain transparency as mentioned in the data sharing statement. In addition, previous reports have made bold statements on Pfizer's incompetency to maintain blinding in clinical trials (Kolstoe, 2021). Despite these allegations, an external review team ensured successful blinding and was independent of Pfizer. Crucially, no conflicts of interests were reported, but it is reasonable to argue that Pfizer may have put financial pressures on the authors to gain some control on the work. I believe this did not occur as the authors reported on adverse events occurring more frequently in their treatment groups which goes against the will to display exaggerated positive results. In conclusion, I believe this trial was conducted ethically as no conflict of interest, tampering of results, and outside financial pressures were immediately evident. Issues relating to participant safety and consent were