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Business Insight presented by Arlington Dermatology Difficulties in Clinical Research Many patients ask me why it takes so long sometimes to put new drugs on the market. This is a very complex question and requires understanding of the entire research process. First of all, this is all about safety and the risk/ benefit ratio. Secondly, it is also about novelty. Let's explain it in simple case examples. We all want good medicines that work and cure or treat diseases. How do we know that these medical products are safe? The only way is to conduct a series of studies: phase 1, using healthy volunteers and mostly focusing on toxic behavior of the new drugs; later, phase 2, studies examining proper dosing and effectiveness on patients in smaller groups, but with a given disease, and finally phase 3, when larger groups of patients are enrolled, doses are usually established, and we are observing efficacy and long-term safety of the drugs. Now, three phases can take months or years; all depends on how long the life of the drug some sponsors discontinue development just is and how quickly we enroll patients who are volunteers. The process of enrolment is probably the most challenging part of the because of good competition and potential studies. There are many patients who need the price decrease. But this really does not happen new drugs but not many wish to participate in in real market. Companies invest heavy funds clinical trials. And this is for multiple reasons: they do not know the effects of the new drug on their bodies, they do not like to'experiment, that drug prices are absolutely out of control they do not like the discipline that every new protocol requires, including many medical visits and blood tests. The problem is that we cannot do it in any different way. Thus, the answer to the question about the duration of time it takes to get any new drug to the market really depends on us, as a community my competency to discuss it. What I know is of patients, with the diseases which need new drugs. There is also an issue of novelty. Nothing products because this is the only way to have is more annoying to the researchers than sudden stopping of a study in process. Patients get upset, treatments are discontinued, more paperwork needs to be complete, but it happens for two reasons: new safety problems or similar drugs being developed and approved weeks and not years. The most challenging earlier creating an issue of the new drug not being novel anymore. Regulatory authorities all have the result in place: multiple and safe as well as pharmaceutical sponsors do not want 10 identical drugs on the market. They life. are not needed and the duplication of efforts costs loss of income to continue research. So, for economic and pragmatic reasons. You can argue that the more the better in developing the drugs and they translate those funds into the future pricing. I agree in our country and my practice is affected by that factor. I want to prescribe better, safer, and more effective medication but I do not want my patients to suffer financially to be able to use these new drugs. I guess I do not have a solution for that problem as it is way out of that we all should be active participants in the processes of developing of the new medicinal them available to our benefit. This is how it was possible to develop the COVID-19 vaccines: there were thousands of volunteers to sign up for clinical trials. The enrollment process was completed in several part of research turned into a breeze, and we vaccines that allow us to have a much better 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 Difficulties in Clinical Research Many patients ask me why it takes so long sometimes to put new drugs on the market. This is a very complex question and requires understanding of the entire research process. First of all, this is all about safety and the risk/ benefit ratio. Secondly, it is also about novelty. Let's explain it in simple case examples. We all want good medicines that work and cure or treat diseases. How do we know that these medical products are safe? The only way is to conduct a series of studies: phase 1, using healthy volunteers and mostly focusing on toxic behavior of the new drugs; later, phase 2, studies examining proper dosing and effectiveness on patients in smaller groups, but with a given disease, and finally phase 3, when larger groups of patients are enrolled, doses are usually established, and we are observing efficacy and long-term safety of the drugs. Now, three phases can take months or years; all depends on how long the life of the drug some sponsors discontinue development just is and how quickly we enroll patients who are volunteers. The process of enrolment is probably the most challenging part of the because of good competition and potential studies. There are many patients who need the price decrease. But this really does not happen new drugs but not many wish to participate in in real market. Companies invest heavy funds clinical trials. And this is for multiple reasons: they do not know the effects of the new drug on their bodies, they do not like to'experiment, that drug prices are absolutely out of control they do not like the discipline that every new protocol requires, including many medical visits and blood tests. The problem is that we cannot do it in any different way. Thus, the answer to the question about the duration of time it takes to get any new drug to the market really depends on us, as a community my competency to discuss it. What I know is of patients, with the diseases which need new drugs. There is also an issue of novelty. Nothing products because this is the only way to have is more annoying to the researchers than sudden stopping of a study in process. Patients get upset, treatments are discontinued, more paperwork needs to be complete, but it happens for two reasons: new safety problems or similar drugs being developed and approved weeks and not years. The most challenging earlier creating an issue of the new drug not being novel anymore. Regulatory authorities all have the result in place: multiple and safe as well as pharmaceutical sponsors do not want 10 identical drugs on the market. They life. are not needed and the duplication of efforts costs loss of income to continue research. So, for economic and pragmatic reasons. You can argue that the more the better in developing the drugs and they translate those funds into the future pricing. I agree in our country and my practice is affected by that factor. I want to prescribe better, safer, and more effective medication but I do not want my patients to suffer financially to be able to use these new drugs. I guess I do not have a solution for that problem as it is way out of that we all should be active participants in the processes of developing of the new medicinal them available to our benefit. This is how it was possible to develop the COVID-19 vaccines: there were thousands of volunteers to sign up for clinical trials. The enrollment process was completed in several part of research turned into a breeze, and we vaccines that allow us to have a much better Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net