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Business Insight Will we have a vaccine? Will we have a remedy? It has been quite a long time since 1 focused on the clinical trials processes in my writings to you. It is worth reminding how much we depend on these processes that bring new medications to our lives and how important it is that those processes are conducted with care and safety of patients in their proceeding. There are thousands of new discoveries made in medicine every year. Before any new drug molecule is tested on humans, it must go through pre-clinical studies, which are animal and lab studies. Once the potential of safety and non- or low- toxicity is established, scientists move to clinical studies, studies on humans. Phase 1 studies are limited in size, often to 20-50 patients who are healthy volunteers. They do not have any particular disease that is being studied and their role is to allow various doses of the drug to be tried, Often. was visited by FDA five times, with a perfect the doses escalate until scientists-doctors observe a certain level of toxicity and then, the study establishes the borderline that can never be crossed. Many volunteers in phase 1 studies get sick, especially if they are exposed to bacteria or viruses to check if the drug is working. The role of phase 1 is crucial but only 12% of drugs studied in phase 1 actually gets approval for the medicine to use. Successful phase I studies move further to phase 2 where larger samples of patients are used, usually 150-200, and they are patients who often do have a particular disease. Phase 2 studies continue establishing safety but also measure efficacy of the drug. Eficacy means how well patients are responding to the drug. Phase 2 trials introduce also placebo (non-drug vehicle) in order to receive non-bias true results. Phase 2 studies get unblinded for the true results only after all data is locked and available. If phase 2 study is projecting well and safe, the process moves to phase 3. There, the number of patients is much larger, often over 1000, and the focus continues on safety causing more risk and damage than benefit. but is really establishing how well the drug works on a particular disease. Phase 3 studies are called pivotal because their data gives a background for FDA to issue an approval. FDA follows very strict safety and ethical keep it in mind whenever you hear the news guidelines on how studies are conducted and routinely does inspections of medical sites like mine, in order to make sure that the study was conducted with attention to the protocol, details, and patients' safety. Our practice has done over 200 studies and record of compliance. Many of the patients of the practice participated in the studies, often long-term and continue coming back for the new ones. We do not conduct phase 1 studies and majority of our projects are in the final phase 3. It is critical to understand that the sample of patients who tried the new medication or vaccine must be large before the drug can be approved. It also must be coming from various age groups and gender groups, as well as different racial groups. Thus, majority of the studies are conducted globally so data for analysis include female/ male factor, younger and older population, representatives of African, Asian, European, and American decent. FDA works very closely with the matching respective institutions around the globe, like PMDA in Japan or EU in Europe, and data is shared and often analyzed together. Before we jump to conclusions that some drug is great and will save the world, we must make sure it actually will not kill people. There have been many cases of hopeful drugs Doctors-researchers, like me, must be very objective and never forget to assess the risk/ benefit ratio when conducting the studies and prescribing medicines to patients. Please, of some miracle coming. tay safe! Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight Will we have a vaccine? Will we have a remedy? It has been quite a long time since 1 focused on the clinical trials processes in my writings to you. It is worth reminding how much we depend on these processes that bring new medications to our lives and how important it is that those processes are conducted with care and safety of patients in their proceeding. There are thousands of new discoveries made in medicine every year. Before any new drug molecule is tested on humans, it must go through pre-clinical studies, which are animal and lab studies. Once the potential of safety and non- or low- toxicity is established, scientists move to clinical studies, studies on humans. Phase 1 studies are limited in size, often to 20-50 patients who are healthy volunteers. They do not have any particular disease that is being studied and their role is to allow various doses of the drug to be tried, Often. was visited by FDA five times, with a perfect the doses escalate until scientists-doctors observe a certain level of toxicity and then, the study establishes the borderline that can never be crossed. Many volunteers in phase 1 studies get sick, especially if they are exposed to bacteria or viruses to check if the drug is working. The role of phase 1 is crucial but only 12% of drugs studied in phase 1 actually gets approval for the medicine to use. Successful phase I studies move further to phase 2 where larger samples of patients are used, usually 150-200, and they are patients who often do have a particular disease. Phase 2 studies continue establishing safety but also measure efficacy of the drug. Eficacy means how well patients are responding to the drug. Phase 2 trials introduce also placebo (non-drug vehicle) in order to receive non-bias true results. Phase 2 studies get unblinded for the true results only after all data is locked and available. If phase 2 study is projecting well and safe, the process moves to phase 3. There, the number of patients is much larger, often over 1000, and the focus continues on safety causing more risk and damage than benefit. but is really establishing how well the drug works on a particular disease. Phase 3 studies are called pivotal because their data gives a background for FDA to issue an approval. FDA follows very strict safety and ethical keep it in mind whenever you hear the news guidelines on how studies are conducted and routinely does inspections of medical sites like mine, in order to make sure that the study was conducted with attention to the protocol, details, and patients' safety. Our practice has done over 200 studies and record of compliance. Many of the patients of the practice participated in the studies, often long-term and continue coming back for the new ones. We do not conduct phase 1 studies and majority of our projects are in the final phase 3. It is critical to understand that the sample of patients who tried the new medication or vaccine must be large before the drug can be approved. It also must be coming from various age groups and gender groups, as well as different racial groups. Thus, majority of the studies are conducted globally so data for analysis include female/ male factor, younger and older population, representatives of African, Asian, European, and American decent. FDA works very closely with the matching respective institutions around the globe, like PMDA in Japan or EU in Europe, and data is shared and often analyzed together. Before we jump to conclusions that some drug is great and will save the world, we must make sure it actually will not kill people. There have been many cases of hopeful drugs Doctors-researchers, like me, must be very objective and never forget to assess the risk/ benefit ratio when conducting the studies and prescribing medicines to patients. Please, of some miracle coming. tay safe! Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net