I'm Todd Schlesinger. In this presentation, I am going to discuss Investigator-Initiated Studies, or IIS, which are also referred to as Investigator-Initiated Research, or IIR, and as Investigator-Initiated Trials, or IITs. I will mainly refer to them as IITs for the purposes of this activity. An IIT is research that comes from an idea that an investigator has and is either funded by the investigator or through a grant from a company that's interested in the outcome. A few years ago, I was asked to author a chapter that covers how one might get started in clinical trials in this book that's a nice primer on dermatology clinical trials. IITs may be employed to examine outcomes that might not have been a part of the registration trials for a drug or part of the research program for a device or product. In many cases, IITs are solicited from investigators by pharmaceutical companies or device makers after the product is approved. The goal might be to look at the existing data in a different way, or to examine new data that's being generated in Phase IV, also known as the post-marketing period. However, an IIT could be used earlier in the development process as well. The study design is variable and based on the idea that the investigator has. IITs are done for a number of reasons, some examples of which are listed here. Personally, I've used IITs to study outcome measures, pharmacoeconomic data, and safety as examples. I've also used them to simply get photos in cases where they were not obtained in the registration trials. These are the key differences between an IIT and a sponsor-initiated trial. When you are the principal investigator on an IIT, you are the sponsor and have significant additional responsibilities that you would not have otherwise. The reason for this is to eliminate the influence the entity funding the research has on the process and the outcome. In my opinion, protocol design and safety reporting are the two larger items that would be handled by a sponsor in the usual case of a sponsor-initiated trial. These are some of the basics of conducting trials that investigators would consider when building their research facility, practice, or center. This is the general timeline of an IIT, which requires a research site meeting, essential requirements to be established, and then the steps in the process. On the left is a sample schedule of study procedures. Here, there are some specific examples of trials you may run across with certain requirements. Each trial has its own set of needs, but there is a lot of overlap between them. In addition to the usual equipment a site is required to have, an investigator will need to budget for and obtain any specialized equipment that may be needed for the IIT. Usually this would be provided in the case of a sponsor-initiated trial. Of note, the investigational product or IP, and this could be a device or over-the-counter product, is usually provided by the company funding the study. Listed are some of the things you can do to build up the reputation of your site and get more studies. Ask your colleagues to recommend your site when they fill out feasibility questionnaires. Many of them ask for other potentially interested sites. There are many reasons that some investigators choose to conduct IITs. These are some of the important ones, but I think that a sense of curiosity is one of the most important motivating factors. Being keenly interested in the outcome and also the process makes it more interesting and rewarding to do this kind of work. Of course, revenue is important as well, and you can design your own budget and negotiate that with the company funding the research. On the other hand, and as I mentioned earlier, IITs are a different level of responsibility on top of that which is already associated with being an investigator. You are the one who sees it all through and without the monitoring support that you'd normally have. Now that you have your IIT all approved, funded, and ready to go, it's time to market it to fine subjects. You may already have some in mind, but just like any other trial, you can create a recruitment plan. Usually, time is of the essence, so being able to fully enroll your IIT without excessive delay will result in both you and your funding company being happier. The last topic I'll cover today, that is the budgeting process. You will want to create an outline that looks somewhat like what is shown here. In it, you will detail each process in the study, accounting for your costs plus profit and overhead. Be sure to include substantially everything you do such as protocol development, IRB submission, continuing reports, safety reporting, recruiting, screen fails, study report, archiving, pharmacy, and source document creation, all as a non-exhaustive list. We use an attorney with experience in the field to review our agreements. You will need to have a clinical trial agreement. Your attorney can create one for you if you don't have one. In conclusion, IITs can be fun, rewarding, and help your center be financially successful as well. As a leader in your field, consider discovering the answers to your own questions. Thank you for your attention. This concludes my presentation.

Investigator-Initiated Trials

sponsor-initiated trials

research funding

protocol design

effective recruitment