Business Insight presented by Arlington Dermatology Final Thoughts On Clinical Research If you are one of our patients, you know that clinical research operations are a crucial part of our clinic functions. We are proud of it. It allows us to constantly learn about new medical discoveries, it helps us understand where medical dermatology is heading in the future, and it offers great opportunities to our patients' care. Research participants do not pay for medical care or medication, so, for patients with limited budgets and poor insurance, it is a good alternative to receive care at no charge. We, as medical professionals, have access to the most novel and often superior medications for many disorders that were otherwise underserved. But clinical research is not for everybody. When we meet initially, offering it as an option, we spend a fair amount of time discussing prior medical history, ability to keep the schedule of the visits, and many other issues that might contribute to a successful clinical research project. Patients' safety and positive risk/ benefit ration are our guidelines in every case. One of the areas that we have not discussed so far is studies in, so-called phase 4 or post-marketing phase. They do not try medications for approval. These drugs are already approved and can be purchased commercially. They might be expensive, but they are available. The pharmaceutical sponsors may be requested by FDA to conduct more specific research, focusing on a very narrow data collection. Or the sponsors may want to do it on their own and compare their data and outcomes with prior results. A good example could be a recent study in psoriasis, using a well-known and established biologic, but only to follow up patients with scalp and genital psoriasis. Obviously, the medication use is not selective to the area, and it will work on the whole body, but the focus of data collection is scalp and genitals. No other data is collected. Patients do not come very frequently, because the drug is known as safe. There is no frequent bloodwork. Activities are limited, but we still collect data showing how quickly the areas of interest improve. Post-marketing studies still require compliance and following Good Clinical Practice (GCP), but the likelihood of the negative risk on these studies is minimized to almost 0. They also do not accept patients who might have used the drug commercially. But, otherwise, the opportunities they offer are excellent and easy for patients to follow. With the new year, there will be many new opportunities to learn more about our clinical research projects. We really encourage patients to ask questions and talk to our research staff. The meetings with research personnel are free of any charges. They may take as long as you need to ask all your questions. And we can assure you that you will learn a lot about your condition and your treatment options. Currently on-going and planned studies are for psoriasis and atopic dermatitis-eczema, both systemic and topical treatments. We are expecting more indications to come soon. Our research department is open 6 days a week, with flexible hours, and offers multilingual staff. Please, call our regular phone number and mention research or studies. We will assist you instantly. 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 Final Thoughts On Clinical Research If you are one of our patients , you know that clinical research operations are a crucial part of our clinic functions . We are proud of it . It allows us to constantly learn about new medical discoveries , it helps us understand where medical dermatology is heading in the future , and it offers great opportunities to our patients ' care . Research participants do not pay for medical care or medication , so , for patients with limited budgets and poor insurance , it is a good alternative to receive care at no charge . We , as medical professionals , have access to the most novel and often superior medications for many disorders that were otherwise underserved . But clinical research is not for everybody . When we meet initially , offering it as an option , we spend a fair amount of time discussing prior medical history , ability to keep the schedule of the visits , and many other issues that might contribute to a successful clinical research project . Patients ' safety and positive risk / benefit ration are our guidelines in every case . One of the areas that we have not discussed so far is studies in , so - called phase 4 or post - marketing phase . They do not try medications for approval . These drugs are already approved and can be purchased commercially . They might be expensive , but they are available . The pharmaceutical sponsors may be requested by FDA to conduct more specific research , focusing on a very narrow data collection . Or the sponsors may want to do it on their own and compare their data and outcomes with prior results . A good example could be a recent study in psoriasis , using a well - known and established biologic , but only to follow up patients with scalp and genital psoriasis . Obviously , the medication use is not selective to the area , and it will work on the whole body , but the focus of data collection is scalp and genitals . No other data is collected . Patients do not come very frequently , because the drug is known as safe . There is no frequent bloodwork . Activities are limited , but we still collect data showing how quickly the areas of interest improve . Post - marketing studies still require compliance and following Good Clinical Practice ( GCP ) , but the likelihood of the negative risk on these studies is minimized to almost 0. They also do not accept patients who might have used the drug commercially . But , otherwise , the opportunities they offer are excellent and easy for patients to follow . With the new year , there will be many new opportunities to learn more about our clinical research projects . We really encourage patients to ask questions and talk to our research staff . The meetings with research personnel are free of any charges . They may take as long as you need to ask all your questions . And we can assure you that you will learn a lot about your condition and your treatment options . Currently on - going and planned studies are for psoriasis and atopic dermatitis - eczema , both systemic and topical treatments . We are expecting more indications to come soon . Our research department is open 6 days a week , with flexible hours , and offers multilingual staff . Please , call our regular phone number and mention research or studies . We will assist you instantly . Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net