This section is on the importance of monitoring recruitment efforts in a clinical trial and also the importance of monitoring participant retention in a clinical trial. Let's start with the screening process. Here I've depicted a Screening Log, a way for sites to record the participants they've screened, and a way for sites to record and report the number of participants they've screened, their characteristics, and the main reason that participants fail screening. Then we can monitor what are the barriers to a particular trial and see if any of these barriers are modifiable. Here's the results of a Screening Log from a trial of patients with chronic obstructive pulmonary disease, COPD. In this particular trial, some of the eligibility criteria were hard and fast. We couldn't enroll someone who was unable to perform the procedures required in the trial. But we did find, as we went along, that our criteria for lung function spirometry were actually a big barrier to the trial and weren't really necessary to protect patients, nor were they critical to the goals of the trial. By monitoring that, we learned that this was a barrier and we modified it so it didn't continue to be a barrier. You need to be monitoring as you go along. On this slide, I've depicted a graphic from our website where sites interacts, enter data, and can see in real-time how randomization is going. Note that we display it by site so that we implicitly encourage competition between sites. We also monitor recruitment over time. Here, I have depicted another one of the recruitment graphs that we have on our website that shows how many participants have been recruited by week so we can monitor trends in recruitment and ensure that momentum is building and that we keep going. In this particular slide, you can see there is a dead period in 2020 that was due to the COVID-19 pandemic, which caused us to close recruitment for about a six-month period. This slide depicts one of our favorite graphs for showing recruitment information. We call it a lollipop graph because the images on the graph look like lollipops. On the y-axis, we have dates and it stays since the site last recruited a participant. On the x-axis, we have each site. Each site has their own lollipop. If they have a long stem on their lollipop, that means that it's been a while since they've recruited a participant, and the top of the lollipop, the actual pop we have a circle and in the middle of the circle is the number of participants they have recruited. The more participants they recruit, the bigger the lollipop gets in terms of the circle, but if you are recruiting actively and have recruited recently, you'll have a short lollipop. The goal is to have a short lollipop with a fat head. What we look for when we look overall is that we're looking for a nice green, short, and thick. This graphic helps us identify the weeds where our problem areas are and so that we can reach out to those particular sites and see if we can help them get recruitment going. I've talked a lot about recruitment. But recruitment is for not if a participant doesn't complete the trial. Retention is essential for the success of a trial. Everyone who's enrolled and randomized in a trial is analyzed in a trial. Whether they ever got the treatment, whether they completed follow-up or not. Not only do we spend a lot of time monitoring recruitment, we also spend quite a bit of time monitoring retention. On this slide, we depict the follow-up for each participant enrolled in the trial. They are stacked on each other. Each participant has an individual number, and then across the x-axis, the perfect participant is solid gray across the graph. When we see white spaces in the graph means that there have been missed follow-up visits. Overall, the graph lets us know where we are in the trial, how much of the information needed to complete the trial, how much information we've already collected for the trial, and the upper area that is blank is the information we still need to fill in. That's the 3,000 foot-view when you want to look at the whole trial overall. But we also monitor by clinic so that we can look at each site in terms of completion of visits and data collection forms, and again easily identify problems and also encourage competition. Finally, we also provide sites with tools for monitoring individuals. I've depicted a grid that is part of our data systems. In this table or grid we have a row for each participant. The columns are individual data collection points, and they are grouped together by visit. Each column depicts individual data items that are grouped together by visit. We display them with graphics that shows what's been completed. That's what we want to see a lot of, completed. What's missing that has not been completed, that's outstanding and possibly overdue, and then some of the gray area in between where the data collection form has been entered, but it has missing items on it. This is a tool for sites to help them keep up on their follow-up. All of these tools and graphics are designed to keep the trial on everyone's radar. We have live monitoring so people can get positive feedback right away when they've been rolled up participant or entered some data. We monitor that and monitor the screening and provide regular summary reports to be reviewed by the leadership of the trial to identify problems, but also by the sites involved in the trial so they can see how they're doing. Another strategy for keeping the trial on sites' radars is to have regular recruitment calls to discuss strategies for recruitment and what barriers they are encountering and allowing people to exchange information. There are incentives for enrolling participants. If we know that a site is lagging, then they may be put on probation or eventually dropped if they can't pick it up. Finally, even with all of the efforts on monitoring and providing feedback and tools, we always need to be thinking of new strategies. Whether we need to add sites, add more financial incentives try to have outreach to a different population, whether that would be a population of patients or different clinicians to provide new pathways for participants to enroll in a trial. It's a never ending battle until you get to the finish line. You crawl, you walk, and then you run. You're always adding to your efforts. In summary, some thoughts on recruitment. My mentor famously says, "The best way to cure a disease is to start a clinical trial." Meaning that sites will say, "Oh, yes, we have tons of patients like that." But once you start the trial, those patients turn out to be hard to find. The design of the trial has a big influence on the recruitment potential, planning for recruitment is essential. You need to allocate the resources and time. You need to have multiple strategies. One strategy is tapped out, you can start to rely on another one. You have to remember that without participants, a trial will fail. One of the most important things is really keeping the participants' needs front and center and make sure that they are satisfied with their experience in a clinical trial. Lastly, you need to recognize it's a team effort that involves working with all the staff and the participants.
