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    November 12, 2021
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Business Insight presented by Arlington Dermatology How does it work? Enrollment in clinical trials is the most challenging part of research. Patients, who are volunteers, must follow the protocol that is given to the doctors-researchers by the pharmaceutical sponsor. Those protocols are not issued accidentally: they are a result of a huge teamwork, analyzing all prior experiences, safety data, prior use, as well as chemical information on the drug to be studied. Protocols must be also reviewed by ethical boards, which consist of medical and non-medical personnel, reviewing all aspects of possible risk in each study. Once the protocol is approved, sponsors reach out to doctors-researchers. Doctors- researchers must have a certain level of experience, knowledge, and medical expertise in a particular indication. For instance, to conduct a psoriasis study, a doctor must have a special training in psoriasis, assessing the disease, differentiating it from other similar disorders, and this training must be updated every 2-3 years. I previously told you medicine is not a status quo field: everything of repetition, but it is all about safety. changes quite frequently, including norms and standards of care, which makes any training and its schedule. Any deviations from that obsolete if not updated accordingly. Doctors-researchers receive a grant from a pharmaceutical sponsor to conduct a study. Usually, they must commit to enroll a certain number of patients with the particular report the changes of the schedule as protocol disease. The grant serves as a compensation for all work on the study, including pays to the staff and stipend for the patients. Regardless keep their schedules as presented. of whether the doctor or the staff spend 10 minutes or 50 minutes with a patient, they travel to every visit. Usually, the payments are receive the same pay. Time dedicated to the studies is not just seeing patients. Seeing term studies, at the end of the calendar year. patients is the most rewarding time in a sense of medical satisfaction but it serves for about 10% of work. 90% of staff and doctors work have you had any medical problems during the last week, month, or so? Yes, there is a lot Patients get re-evaluated as per the protocol schedule must be documented. Often, they do not matter very much but sometimes, they do, especially if medication is delayed or missed. The staff and doctors must then deviations. No, we do not like doing that too often. And we always remind patients to try to Patients do get paid for their time and done at the end of the study and, for the long- Payments vary from protocol to protocol but are never lower than some $50 per visit and never higher than $100. Patients receive these payments only for the visits they completed. While all the research processes might sound complicated, and they are, conducting happens when patients are gone and data from visits must be documented and entered to electronic systems. Lab tests must be processed and sent to the central laboratory, research is extremely rewarding for all. and other tests transmitted to proper vendors. Every time something happens somewhere Secondly, patients receive all medical care for in the global study environment for any study. free. And finally, we all learn about the future all the staff and doctors-researchers must update their risk/benefit knowledge. Only that you would like to discuss it more, please call us. way, they can be sure continuing the study is safe and ethically proper. Patients sometimes get tired of our questions repeating every visit: First, we are finding new and better drugs. of medicine and a better world for all of us. If We can meet and talk about how you can help. 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 How does it work? Enrollment in clinical trials is the most challenging part of research. Patients, who are volunteers, must follow the protocol that is given to the doctors-researchers by the pharmaceutical sponsor. Those protocols are not issued accidentally: they are a result of a huge teamwork, analyzing all prior experiences, safety data, prior use, as well as chemical information on the drug to be studied. Protocols must be also reviewed by ethical boards, which consist of medical and non-medical personnel, reviewing all aspects of possible risk in each study. Once the protocol is approved, sponsors reach out to doctors-researchers. Doctors- researchers must have a certain level of experience, knowledge, and medical expertise in a particular indication. For instance, to conduct a psoriasis study, a doctor must have a special training in psoriasis, assessing the disease, differentiating it from other similar disorders, and this training must be updated every 2-3 years. I previously told you medicine is not a status quo field: everything of repetition, but it is all about safety. changes quite frequently, including norms and standards of care, which makes any training and its schedule. Any deviations from that obsolete if not updated accordingly. Doctors-researchers receive a grant from a pharmaceutical sponsor to conduct a study. Usually, they must commit to enroll a certain number of patients with the particular report the changes of the schedule as protocol disease. The grant serves as a compensation for all work on the study, including pays to the staff and stipend for the patients. Regardless keep their schedules as presented. of whether the doctor or the staff spend 10 minutes or 50 minutes with a patient, they travel to every visit. Usually, the payments are receive the same pay. Time dedicated to the studies is not just seeing patients. Seeing term studies, at the end of the calendar year. patients is the most rewarding time in a sense of medical satisfaction but it serves for about 10% of work. 90% of staff and doctors work have you had any medical problems during the last week, month, or so? Yes, there is a lot Patients get re-evaluated as per the protocol schedule must be documented. Often, they do not matter very much but sometimes, they do, especially if medication is delayed or missed. The staff and doctors must then deviations. No, we do not like doing that too often. And we always remind patients to try to Patients do get paid for their time and done at the end of the study and, for the long- Payments vary from protocol to protocol but are never lower than some $50 per visit and never higher than $100. Patients receive these payments only for the visits they completed. While all the research processes might sound complicated, and they are, conducting happens when patients are gone and data from visits must be documented and entered to electronic systems. Lab tests must be processed and sent to the central laboratory, research is extremely rewarding for all. and other tests transmitted to proper vendors. Every time something happens somewhere Secondly, patients receive all medical care for in the global study environment for any study. free. And finally, we all learn about the future all the staff and doctors-researchers must update their risk/benefit knowledge. Only that you would like to discuss it more, please call us. way, they can be sure continuing the study is safe and ethically proper. Patients sometimes get tired of our questions repeating every visit: First, we are finding new and better drugs. of medicine and a better world for all of us. If We can meet and talk about how you can help. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net