Business Insight Why is Clinical Research Important? Part 1. Over the last 2-3 years, our country heard a lot of new terms that previously did not matter to most Americans. Studies, testing, trials, FDA, approvals, emergency approvals and more. COVID-19 pandemic brought these terms and facts associated with them to life and mind of everyone watching TV or Internet. Prior to that, very few people were interested in what FDA does and how they conduct the processes of approvals of new drugs. And their processes. have been consistent for many years. Our own practice has been conducting clinical trials for 18 years. The processes might have been modified, mostly due to technology, but they have always consisted of the same phases: phase 1-for healthy volunteers, almost an entry level for the new drug tried on humans, phase 2 usually consisting of a smaller group of patients and limited in scope to closely monitor safety and effectiveness, and phase 3, which uses much larger of a sample, often going into thousands, and monitoring effectiveness and safety for a larger population. Phase 3 studies serve as pivotal material for FDA, a new drug application for a license and approval to market the drug. Our country is not the only one requiring the above steps. In the real world of pharmaceutical industry, globalization started many years ago and is practically impossible to avoid. It has a lot of positive outcomes: there are many medical inventions occurring in other countries and we, in the USA, benefit from them due to global processing of the clinical research. In other words, European Union, Japan, Australia, and most of the rest of the world must use the rules of commonly regulated processes in regard to safety and approval process. Thus, they eventually can market their drug everywhere. It sounds much simpler than it is in real life, but the benefits of sharing medical and pharmaceutical novelties and discoveries is crucial. Any studies that are conducted after the approval are in phase 4 called post-marketing, which delivers on-going safety and efficacy information to the industry and regulatory agencies. Some of you may read anecdotes about slow. and inefficient processes of the FDA, which is our American regulatory agency. Based on 18 years of my own experience and my team's experience I disagree with this. I have been visited by 7 different inspectors from FDA and 2 inspectors from Japan. I found all of them presented by Arlington Dermatology extremely well-prepared to do their jobs, very well-educated in medical science, and very fast working. None of them made any unreasonable comments or demands of me and my staff. They love transparency, order, and clear answers. What they inspected was followed up by rapid reviews in their offices and got approved fast. All my inspections were pre-approval inspections and never found any deficiencies. Contrary to the above, I find that the clinical trials processes are dramatically slowed down by the managing companies that conduct the trials. Some of them are not pharmaceutical companies but the 3rd parties hired to just organize and conduct the study. One slowing factor is recruitment of patients. Unlike for COVID-19 studies, where thousands of volunteers lined up immediately, it is not unusual to continue enrollment for some studies for 2-3 years. There is a lot of disorganization in the managing companies, hiring people with no prior experience or fake resumes. There is a lot of wasted time and materials. It all projects on how soon and how successfully the study will end. And how soon the new drug will be approved. You, as a patient, should know that and should be a part of it to make it better. To be continued...... Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight Why is Clinical Research Important ? Part 1 . Over the last 2-3 years , our country heard a lot of new terms that previously did not matter to most Americans . Studies , testing , trials , FDA , approvals , emergency approvals and more . COVID - 19 pandemic brought these terms and facts associated with them to life and mind of everyone watching TV or Internet . Prior to that , very few people were interested in what FDA does and how they conduct the processes of approvals of new drugs . And their processes . have been consistent for many years . Our own practice has been conducting clinical trials for 18 years . The processes might have been modified , mostly due to technology , but they have always consisted of the same phases : phase 1 - for healthy volunteers , almost an entry level for the new drug tried on humans , phase 2 usually consisting of a smaller group of patients and limited in scope to closely monitor safety and effectiveness , and phase 3 , which uses much larger of a sample , often going into thousands , and monitoring effectiveness and safety for a larger population . Phase 3 studies serve as pivotal material for FDA , a new drug application for a license and approval to market the drug . Our country is not the only one requiring the above steps . In the real world of pharmaceutical industry , globalization started many years ago and is practically impossible to avoid . It has a lot of positive outcomes : there are many medical inventions occurring in other countries and we , in the USA , benefit from them due to global processing of the clinical research . In other words , European Union , Japan , Australia , and most of the rest of the world must use the rules of commonly regulated processes in regard to safety and approval process . Thus , they eventually can market their drug everywhere . It sounds much simpler than it is in real life , but the benefits of sharing medical and pharmaceutical novelties and discoveries is crucial . Any studies that are conducted after the approval are in phase 4 called post - marketing , which delivers on - going safety and efficacy information to the industry and regulatory agencies . Some of you may read anecdotes about slow . and inefficient processes of the FDA , which is our American regulatory agency . Based on 18 years of my own experience and my team's experience I disagree with this . I have been visited by 7 different inspectors from FDA and 2 inspectors from Japan . I found all of them presented by Arlington Dermatology extremely well - prepared to do their jobs , very well - educated in medical science , and very fast working . None of them made any unreasonable comments or demands of me and my staff . They love transparency , order , and clear answers . What they inspected was followed up by rapid reviews in their offices and got approved fast . All my inspections were pre - approval inspections and never found any deficiencies . Contrary to the above , I find that the clinical trials processes are dramatically slowed down by the managing companies that conduct the trials . Some of them are not pharmaceutical companies but the 3rd parties hired to just organize and conduct the study . One slowing factor is recruitment of patients . Unlike for COVID - 19 studies , where thousands of volunteers lined up immediately , it is not unusual to continue enrollment for some studies for 2-3 years . There is a lot of disorganization in the managing companies , hiring people with no prior experience or fake resumes . There is a lot of wasted time and materials . It all projects on how soon and how successfully the study will end . And how soon the new drug will be approved . You , as a patient , should know that and should be a part of it to make it better . To be continued ...... Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net