SHARED CASE ANALYSIS 5
Clinicalresearch is a situation where there is a subset of human subjectswith the research entirely focusing on the human subjects in clinicalprocess. The last few decades have witnessed considerable efforts putforth towards the improvement precise assessment of the scientificvalidity and integrity of randomized clinical trials. These measureshave been carried out on the basis of evidence based medicalpracticing groups, also putting the measure to see that there is astandardized way in which results reported. On matters ethicalissues, they are now taking up greater prominence in the conduct, howinterpretations are under taken, and the use clinical research,especially where researchers are exploring new frontiers that are byfar command meticulous ethical scrutiny.
WhyParticipate In a Clinical Trial?
Beforeany human patient is enrolled in any clinical trial, the trial mustbe reviewed different experts including clinical and researchersensuring that the whole clinical setup is scientifically welldesigned and it is well capable of answering the study question athand. In addition, the clinical trial setup has to be reviewed by aHuman Research Ethics Committee (HREC) that ensures all the set trialprotocols are in line with the set guidelines to follow underclinical trial conducts. As well, the HREC is mandated to evaluatethe scientific merits that come with the clinical trial as part ofthe ethical review they carry out not unless it has previously beconducted elsewhere. The process also ensures that no member of theresearch trial has an undisclosed conflict of interest, thus, makingthe process as ethical sound and with minimal risk as possible(Bernstein, 2006).
Tocreate a higher level of internal validity, inculcation and exclusionof criteria for clinical trials are made relatively rigorous. This isimportant in that the expenditure of human fiscal resources requiredin seeing a clinical trial operational have to be justified by astrong likelihood that scientifically valid and usable result will beobtained (Bernstein, 2006). In Brittany’s case scenario, there is alikelihood of obtaining valid results. These results will not onlyhelp her but also help future cases of brain cancer. In ensuringthese results, the clinical team will ensure that as best as possiblethe clinical trial is well equipped and fair to the study subject,thus, offering the best definitive results.
Theclinical team will investigate all foreseeable harms and be watchfulfor any other unexpected harm. Therefore, the clinical trial isexpected to have a strong chance of offering therapeutic benefits tothe patient. In addition, there are high chances of a better qualityof life after the trial, lowered levels of complications, and highchances of survival. However, Should there be any complicationsduring the clinical trial, then the whole study can be stopped withan independent safety and monitoring committee overseeing the safetyof the whole process (Shapiro and Meslin, 2001).
Therefore,the case of Brittany should be well informed that the clinical trialis to be submitted to research ethical board (REB) which is theclinical investigator’s institution, and the clinical team willwait no matter for how long for a response and it is ready to receiveany suggestions. The clinical team will do its best to comply withsuggestions put across or explain why the suggestion may not work inthe case trial. Thus, the clinical research will be ethicallydesirable since it will represent an attempt by the clinical team tostrive to improve the outcomes of patient’s health. As such,Brittany should take part in the proposed clinical trial.
Bernstein,M. (2006). Ethical guideposts to clinical trials in oncology. CurrentOncology 13(2), 55.
Shapiro,H. T., & Meslin, E. M. (2001). Ethical issues in the design andconduct of clinical trials in developing countries. NewEngland Journal of Medicine345(2),139-42.