Eligibility criteria protocols are one of the most important aspects of current clinical trial regulations that have been put in place by multiple organizations such as the FDA and the IRB. A change brought to eligibility criteria for even a singular study would not only translate to a shift of the people being appointed to participate in the trial, it would involuntarily become a means to alter the entirety of the clinical trial itself. In essence, clinical trials are a means of experimentation by which drugs are tested to be proven safe and effective to use on the human population, and in turn save lives. Considering the delicate nature of experimentation on humans and keeping in mind ethical and functional limitations, the given eligibility criteria protocols must be strict such that vulnerable patients with many risk factors should be excluded so that no unnecessary harm is caused to them. That said, it is important for clinical studies to take into account as many different varying factors as possible (without inducing risk), considering that the people who would eventually take drugs in development would come from a variety of different social, economical, and most importantly, health backgrounds. The first priority in medicine is to save patients’ lives, and as such, specific criteria must be formulated so that no patient is put in more harm than is needed to be, especially since the drug might have a contradicting effect on such patients.
Antibiotic resistance exponentially increased as a result of selective pressures put on bacteria to evolve and survive, with many issues such as incorrect infectious disease diagnoses. The objective of an increased prevalence of diagnostic tests is to minimize misdiagnoses within the infectious disease segment of medicine and to detect if a person has a pathogenic bacterial infection to appropriate the use of antibiotics. Such a device would enable doctors to properly diagnose pathogenic bacterial infections and would mitigate the spread of resistance. Such a machine could also be taken a level further, with the integration of innovative technology, to help doctors identify the strain of bacteria/fungus and even virus that a patient might have, which would make it significantly easier to prescribe the correct medication. Until that time, the machine that we have will definitely aid in lowering the number of misdiagnosed patients and unnecessary antibiotics being administered.
Soil has already proven to be a medium through which antibiotics have been discovered in the past, and considering that it is perhaps the most available to humans of all the places antibiotics are formed, there has yet to be discovered numerous other classes of antibiotics as well. In terms of streamlining the process in analyzing soil samples, one approach to consider is to look for antimicrobial agents in various terrains where there have been proven to have found antibiotics before as well. Chances are that if the soil has been home to one species of antibiotics, it is possible for other species of antibiotics to reside there as well. Conversely, research must also be conducted on terrains that have not been previously tested or have a significant lack of testing to determine if antibiotics reside in the soil in those areas. A key aspect in this is involving organizations such as the Tiny Earth Network through which students around the world can help scientists in the discovery of new antibacterial compounds by analyzing soil near their area. By expanding and investing in such networks, this would rapidly increase the variety and amount of soil that could be scanned for potential antibiotics rather than having a single group of researchers going around the world searching for new compounds, which would waste time and resources.
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Written by Shreya Bhardwaj
Date Published: 12/08/2020
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Sources:
McCarthy, M. (2020). Superbugs. Penguin USA.
What are eligibility criteria, and why are they important? Roswell Park Comprehensive Cancer Center. https://www.roswellpark.org/clinical-trials/eligibility-criteria.
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