Hello, today we're going to talk about effective research study recruitment. My name is Linda Stein Gold, and I'm the Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan. Patient recruitment is one of the critical elements to a successful clinical trial, but we have to find the right patient for the right clinical trial. And they can't just be interested, they have to be qualified, they have to be motivated, and they have to be able to participate. We also want to make sure we have a good diversity in the patient population, because we want to make sure that the clinical trial population accurately mirrors the patient population who have any particular illness. Now, patient recruitment is really expensive. When we look at the budget that we put forth to run these clinical trials, 27% is allocated to patient recruitment to get those patients into the clinical trial. It is no easy task. And if you think about all the time and energy that it takes to get a clinical trial up and running, would you believe that 50% of sites enroll no patients or just one patient? 85% of clinical trials fail to get the patients that they needed for the clinical trials, and 80% of clinical trials don't finish on time because we don't recruit the adequate numbers of patients. Now, the FDA requires that the Institutional Review Board review all activities that are related to research. They have to look at everything. Well, why do we have to have the IRB look at all of our recruitment materials? We do this because abuses have occurred in the past. We have to watch over our recruitment strategies for a number of reasons. One of the abuses in our history is outlined with the Tuskegee syphilis study. In this study, investigators enrolled 600 impoverished African-American sharecroppers who are from Alabama. 399 of these men had latent syphilis and 201 were not infected. They were the control group. They got these patients to participate by promising them free medical care, but they were never informed about the nature of the experiment. They were never informed about their syphilis diagnosis, and they were not given adequate care. As a result of this, over 100 men died as a result of this particular study. And this isn't the only example. There are several studies that looked at abusing prisoners. The first study in Pennsylvania, they exposed prisoners to cancer-causing and radioactive chemicals. In another study, they used juvenile inmates from California and gave them psychotropic drugs despite regulatory prohibitions. So the FDA wants us to keep track and make sure we're doing everything appropriately. We want to make sure that we're not coercing patients to participate. We don't want to promise things that aren't realistic. We don't want to promise a cure beyond what's outlined in the consent form and the protocol. And this is especially true when we have vulnerable patients who might be unduly influenced. Now, who is a vulnerable patient? These are patients who are significantly ill that are dependent on their clinician for care. Ethnic and racial minorities, non-English speaking patients, children, those who are economically disadvantaged, and adults with diminished capacity. Now, when we advertise, we also have to be really careful. It's important that when we're recruiting patients, we not imply for sure that they're going to do well or they're going to have benefits from the study. We have to stay with what's in the consent form and the protocol. We certainly cannot say up front that one drug is going to be better than other drugs or biologics or devices, or that it's necessarily safe and effective. There are additional restrictions on advertising. We can't promise free medical treatment when the intent is only to say that patients will not be charged to participate in the clinical trial. And the FDA believes that advertisements to recruit patients should be limited just to the information that's necessary to determine if a patient is eligible and potentially interested in that clinical trial. It's certainly appropriate to pay patients for their time, but we don't want to emphasize the payment when we're advertising for patients. Now, traditionally, we've used a lot of different methods to identify appropriate patients. We use clinic databases. We can do a database search. We advertise. We can use the newspaper, the radio, the television. And patient support groups are often great sources of information, like the National Eczema Association or the National Psoriasis Foundation. When we let these patient support groups know about studies that are going on, they can disseminate the information to the individuals that are part of these groups and see if they might be interested. And social media is a great avenue, and we get lots of patients using that. There are some newer methods of recruiting. A lot of medical centers use medical record systems like Epic. My hospital happens to use Epic. And there are ways to search from patients who are registered in Epic to see if they might be eligible for a research study. In fact, just yesterday, I got a notification that I might be a good candidate for a research study, and this came through an Epic search. Now, there are newer methods of recruiting. There's something called Research Match. This is a nonprofit program that was funded by the National Institute of Health or the NIH. Here, people can register and put in information about themselves, and researchers can register and put in information about clinical trials that are going on. And then it goes through this network, and you can match up appropriate patients to appropriate clinical research trials. Now, I started doing clinical trials when I was just a resident. So I've been doing them my entire career, and I've learned a lot of things. The first thing is, if I'm trying to fill a study that might be difficult, I'll call patients myself. Patients are often much more at ease when a physician calls them and explains the information. I explain that I've looked through their chart, and this is what this study is offering. I review the inclusion and exclusion criteria in advance. I don't want to bring a patient in who's not going to qualify. Maybe they're on an excluded drug. Maybe they have a depression history or have a history of suicidal ideation, which is exclusionary for the study. Get that up front. You don't want to waste people's time and your own time by bringing in patients who are not appropriate for a particular trial. And also make sure up front that patients have the time to complete the entire study. If they're going to be out of town for a month during the middle of the trial, and they're going to miss visits, don't enroll them. We really want to make sure we get good research patients. What else have I learned? If a patient has a history of non-compliance, do not enroll them in a study. If they're not compliant with their general office visits, they're not going to be compliant with the research study visits either. And maintaining the patient once you get them in the study is equally as important. We want to get that patient in and keep them in for the duration of the clinical trial. We do that by having open lines of communication. My patients have my cell phone number and my clinical trial coordinator's cell phone number so that they can communicate with us when they need to. We have flexible clinic hours. It says here we start at 6 a.m., but sometimes we start at 5.30. I want my office to be your first stop. I don't want you to go to school. I don't want you to go to the office and then think you'll come to me later because we all get busy and it's not going to happen. So come to me first and then go about your day. But sometimes patients will like to come at lunch as well. So I hope I've given you a good overview of what's involved in appropriate recruitment for clinical trials. I think this is such an important job and it really helps to advance the field of dermatology. Thanks so much.

clinical trials

patient recruitment

diverse populations

ethical oversight

recruitment strategies

clinical research

participant recruitment

ethical considerations

diverse participants

dermatology trials