It's a great pleasure and privilege to provide an introductory talk for this amazing course for clinical trial training offered by American Academy of Dermatology. This course is designed not just to teach clinical trial, but to inspire and empower dermatologists who are interested and clinicians who are interested to do clinical trial. Here is me. I'm Afsaneh Alavi, a professor of dermatology at Mayo Clinic, Rochester, Minnesota. This course is a collection of insights from leading experts in dermatology, clinicians, researchers, and thoughtful leaders who generously provided what they learned over years by doing clinical trial. Together, they have distilled their knowledge to provide you with the tools to go beyond what we find in textbook and in the papers, equipping everybody to design, lead, and evaluate impactful clinical trial. Look at the clinical trial structure. You need personnel, you need space, and you need equipment. Over the next couple of sessions in this course, we will journey through every aspects of clinical trial from design and ethics to analysis, implementation, and my hope is that this course transforms your perspective on research and leaves you confident to contribute to this critical area. We are at an exciting time in dermatology. The cost of developing new drugs is high and so many new drugs are coming in dermatology. Eighty-five percent of therapies fail through every clinical development and only half of those reach their phase three, they are approved. Interestingly, patient recruitment is the single biggest cause of clinical trial delay that shows how important it is that you accept the trial that you are able to recruit for it and have at least a patient for that condition that you may want to study. Thirty percent of the phase three early termination is due to enrollment difficulty. Clinical trial in dermatology is rapidly changing area and it's changing our field and our disciplines. It's good to be part of it. When we look at the three pillars of clinical trial, personnel, facility, and equipment, the most, most important aspect of clinical trial unit is the people, the people that you are working with because it's completely a team effort. The good clinical trial units have the good people who care about the result. They are key in performing a good clinical trial and each member of the team has an important role to play. Today, clinical trials are considered a gold standard of research and the number of clinical trials unit contribute to different therapy is continuing to grow. Only in melanoma area, we had, since 2012, we had more than 10 new therapy approved by FDA. Industry-sponsored trial are two-thirds of clinical trial in dermatology and overall and it's even higher in dermatology. And we have some interesting investigator-initiated studies. Studies that are prospective or retrospective, they are not clinical trials. Clinical trials are you study the result of a treatment or an intervention or you are comparing it. In phase one, a small group of human subject are studied to show treatment efficacy, dose range, and potential side effect. In phase two, a larger group of patients are studied to show treatment efficacy. In phase three study, a larger group of patients are studied to show treatment efficacy and overall adverse event and other factors. Phase four are studies that are usually easier to perform, are post-marketing, after a drug is already in the market for long-term adverse event and effect in varying population. Phase two was focused on dose calculation and dosing of that is the best for that efficacy. When you decide to perform clinical trial, you have to inform the sponsors and the first thing that you receive, it would be a site visibility. When you have the site visibility, you need to sign a confidentiality to make sure that you are able and that everything is stay confidential. And then the sponsor share with you a synopsis of protocol and you review if you are able to do this study and the sponsor also look at your qualification. They like to also come, after selection of your sites, they like to come for a qualification and visit for the final selection. And then they see your facility, they see your staff, where you keep the medication and then you have site selection. You hear about this with more detail in other talks. And then the next step would be investigator meeting and I want to recommend that try to be involved, try to read the protocol, try to attend investigator meeting. And then invest after investigator meeting, you need IRB approval and then submission of documents, regulatory document. And the next milestone would be the site initiation. That's when you need to work hard to make sure that you recruit the patient to this study and the right patient. And then the feasibility, the PI is approached by sponsor and it's good to have one person in your site to response this feasibility question that have the number of cases that you have and make sure that you do not overestimate the number of the case because this is in your record that you committed to 10 cases and now you were able to recruit only one or two. And also when PI sign the confidentiality or non-disclosure, this is very important that everything that sponsor is sharing with the site stay confidential and never speak about cases that you have seen in that trial. The sponsor provide when the confidentiality is signed, you get more detailed information and then we talked about the site qualification visit that you need to be present for the site qualification visit and your key staff need to be present for that. And it is important that have a good delegation of work to the staff, then they know each of them are responsible for what part of the study. And after site selection, PI from different sites and staff attend the investigator meeting to discuss the protocol in more and logistic of the protocol in more detail, just repetition of what we mentioned before. And then we have the IRB that could be centralized IRB or local IRB, that's where in academic center the study start up would be much slower because then their IRB may delay some of the work but in community center they have much faster access to IRB approval. And it's important to have everything in place and then subject enrollment. When you are the first site who enroll a subject, it is important more lights on you and when you are the highest enroller in a study, there are some benefit that you will get a good reputation as the high enroller and you will be, you may be part of the study for the publication but at the same time you will be at risk for audit when you are the high enroller. Going what we need, we need principal investigator, we need sub-investigator, it's good to have multiple sub-investigators because it gives you flexibility if you are attending a meeting or you're not available, your sub-investigator see the patient even though ideally we like that one person evaluate the patient through the study. Clinical research coordinator is very important and if you are a young and new site, it's important that your clinical research investigator be experienced. You cannot start with you start a new and clinical research coordinator be absolutely new. It's really tough situation. Administrative staff also play a role. They help you with start of the study, with recruitment to find the cases that are eligible for the study through your database or advertisement, scheduling the patient. They help with data entry and for some of the cases, sites, you need a project manager for every study, you need a laboratory technician to process the tissue and blood. Clinical research coordinator, which is the manpower and main group doing, helping you with the study, even though PI is the main responsible person, CRC needs to be well-versed in all aspect of the protocol. They have to ensure clinical care of subject, be available for communication with the subject. They need to be very good in documentation, very detail-oriented. Not everybody can be a good CRC. They have to be detail-oriented. They help investigator for documentation of assessment. They conduct informed consent and they administer the study drug. When it come to equipment, depend on the sites, you need some basic equipment. Because of confidentiality, all of cabinets that are patient documents should be locked cabinet. You need proper fridge, centrifuge. Some studies need refrigerator, centrifuge, minus 20 freezer or minus 70 freezer, thermometer to monitor and incubator. You need adequate space, lots of storage space and also proper working space for studies because every study has lots of documents, lots of boxes. You need to work on branding and marketing of your site. It is a competitive project. Some sites work with CRO and site management organizations. Before coming here, I was doing clinical trial in community and I couldn't do at the beginning when I started unless I worked with a CRO and I worked with a good CRO to do the contracting and all of the other detail. It is important to continue engage in clinical trial to support advances in science and medicare. This is a future of dermatology. It is we are moving toward decentralized clinical trial. We are digital health can revolutionize clinical trial. It is important for programs to educate our next generation of dermatologists, our residents and trainee in this important matter to be able to be familiar with clinical trial and if they are interested to perform clinical trial, then they know they have some information about it. Being involved in clinical trial help improvement of life and health of many patients. You hear from Dr. Mark LeBowle talking about this that how satisfying is to see that patient get better, help to access to some drugs, to increase value and reduce waste in biomedical research by setting high quality clinical research unit. We help our partner response industry to be successful to develop new drugs and dermatology It's important to provide more and more information and education in clinical trial. That's why this core curriculum is focused on clinical trial for colleagues and residents and everybody who likes to know more about clinical trial. I hope you enjoyed this course and thank you for your attention.

clinical trials

dermatology

medical research

randomized studies

American Academy of Dermatology

patient recruitment

AI integration

teamwork

dermatological research

research ethics

AI technology

digital health

IRB approvals