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    September 4, 2020
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Business Insight presented by Arlington Dermatology Clinical Research; What? Why? How? We must support clinical research. Without it, there would be no progress in medicine. We all want progress and not only during the times of a pandemic. Clinical research is not only for vaccines but all new drugs, devices, and procedures. Clinical research is not blue or red. It is green and grey like the Earth and its sciences. linical research is not black or white. It is transparent. Clinical research is not for rich or poor. It is for everyone. Including seniors and children. Clinical research is not about politics, religions, languages, or individual views. It is and should be about pure science, evidence, novelty, and safety. The reason we practice clinical research is because we want better treatments and cures. What we do in clinical research is about humanity and its everlasting desire for the entire world. This way the scientists to do better, and not about our emotions and opinions that truly may be easily biased. FDA (Federal Drug Administration) and the global society. its equivalents around the world (EMA- European Medicines Agency) follow independent science and should continue biologics, they will tell you how we worked to do so for our own sake. Not without a together and how we cooperated with other reason, they often work together: most of countries, and how we were inspected by the pharmaceutical development is done internationally and globally, and new drugs one goal: to have a safe, novel, and effective seek licensing through multiple regulatory medicine. They will also tell you how many agencies at the same time. All of the times we asked them about any possible authorities require completion of pre-clinical health problems during the studies, how (animal) studies and phase 1, 2, and 3 clinical many times we drew their blood for testing, studies on humans. Only phase 3 studies how many times we checked their vitals or work on a large sample of population, did ECGS. All of it for one goal: safe, novel, allowing trials of the new medicine among regular people, with medical conditions, and in a large sample, making a margin of hard work. It requires open mind and strict error smaller. All agencies globally follow the regulations. It can be fun if things go well, rules established by Declaration of Helsinki, but it may be tragic if they do not. Cutting clearly stating the necessity of following edges in clinical research means future medical ethics and human well-being victims with health problems or even deaths. before any testing is conducted. Introduced in 1964, the regulation became a standard studies very carefully before deciding on of ethical conduct in medical research, conducting them. This means hours of stressing the value of human life and well- reading and learning protocols before we being as well as a need for the new drugs to be beneficial rather than just experimental. American medical researchers like myself never thing black and white, red or blue; we not only must follow the standards of the think science for human well-being. Declaration but they should be happy to have the standards established uniformly and researchers can work together and put their efforts to work together for the good of If you talk to any of my patients who were a part of the research for any of our authorities from the other countries, all for and effective medicine. Clinical research is difficult and requires Our clinical research center selects even think about potential patients. And when we decide about the study to run, we Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight presented by Arlington Dermatology Clinical Research; What? Why? How? We must support clinical research. Without it, there would be no progress in medicine. We all want progress and not only during the times of a pandemic. Clinical research is not only for vaccines but all new drugs, devices, and procedures. Clinical research is not blue or red. It is green and grey like the Earth and its sciences. linical research is not black or white. It is transparent. Clinical research is not for rich or poor. It is for everyone. Including seniors and children. Clinical research is not about politics, religions, languages, or individual views. It is and should be about pure science, evidence, novelty, and safety. The reason we practice clinical research is because we want better treatments and cures. What we do in clinical research is about humanity and its everlasting desire for the entire world. This way the scientists to do better, and not about our emotions and opinions that truly may be easily biased. FDA (Federal Drug Administration) and the global society. its equivalents around the world (EMA- European Medicines Agency) follow independent science and should continue biologics, they will tell you how we worked to do so for our own sake. Not without a together and how we cooperated with other reason, they often work together: most of countries, and how we were inspected by the pharmaceutical development is done internationally and globally, and new drugs one goal: to have a safe, novel, and effective seek licensing through multiple regulatory medicine. They will also tell you how many agencies at the same time. All of the times we asked them about any possible authorities require completion of pre-clinical health problems during the studies, how (animal) studies and phase 1, 2, and 3 clinical many times we drew their blood for testing, studies on humans. Only phase 3 studies how many times we checked their vitals or work on a large sample of population, did ECGS. All of it for one goal: safe, novel, allowing trials of the new medicine among regular people, with medical conditions, and in a large sample, making a margin of hard work. It requires open mind and strict error smaller. All agencies globally follow the regulations. It can be fun if things go well, rules established by Declaration of Helsinki, but it may be tragic if they do not. Cutting clearly stating the necessity of following edges in clinical research means future medical ethics and human well-being victims with health problems or even deaths. before any testing is conducted. Introduced in 1964, the regulation became a standard studies very carefully before deciding on of ethical conduct in medical research, conducting them. This means hours of stressing the value of human life and well- reading and learning protocols before we being as well as a need for the new drugs to be beneficial rather than just experimental. American medical researchers like myself never thing black and white, red or blue; we not only must follow the standards of the think science for human well-being. Declaration but they should be happy to have the standards established uniformly and researchers can work together and put their efforts to work together for the good of If you talk to any of my patients who were a part of the research for any of our authorities from the other countries, all for and effective medicine. Clinical research is difficult and requires Our clinical research center selects even think about potential patients. And when we decide about the study to run, we Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net