Sarah Ruggles is a clinical research administrative assistant at Huron Gastro, an adult medical gastroenterology practice associated with the St. Joseph Mercy Health System and Trinity Health. Sarah uses OneStudyTeam to manage the site’s patient recruitment efforts. We spoke with Sarah to understand her role and how she uses StudyTeam to manage patient recruitment and enrollment.
What does a typical day look like for you?
My main focus is recruitment coordination. StudyTeam is very instrumental in how recruitment goes. I always enter every patient referral into StudyTeam, even if they decide not to participate in a trial or if they are not eligible. Even if they're not interested at the time, they might be interested in the future.
Can you tell us more about your site?
We’re a large community, private adult medical gastroenterology practice specializing in the diagnosis, treatment, and management of disorders that affect the esophagus, stomach, small intestine, large intestine (colon), rectum, liver, gallbladder, bile ducts, and pancreas. Currently, our practice includes 19 physicians who are board-certified in gastroenterology by the American Board of Internal Medicine, five physician assistants/NPs. We’re on a hospital campus, so some of our doctors also do advanced procedures at the hospital. Patients seen in the hospital often get referred to us for a study.
What were your initial perceptions of StudyTeam?
I found it to be very user-friendly when I was getting to know the main functions, and I'm usually able to easily find new features without having to schedule a training call. When I do have a question, [OneStudyTeam] is always great about getting back to me and giving me the information that I need.
What have been your favorite StudyTeam features so far?
I liked the patient tags, and I think the filters are great too. Sometimes using those together really helps. We've had a couple of patients who've had GI surgeries and some of these studies have time limits on surgical history. I can go back to StudyTeam and reevaluate their status. That’s very helpful when you're monitoring eligibility quickly for status changes using the tags.
Does your site use StudyTeam across multiple trials?
Yes. We usually have multiple trials enrolling for several indications. The trials are differentiated by their inclusion/exclusion criteria. Usually there are only one or two variables that make them different. I like that we can add tags because there are certain trials where you absolutely cannot have one condition, so it's really helpful. Having multiple trials and being able to switch from one study to another is really easy when we're entering information.
Does StudyTeam impact how you work with sponsors?
It’s really helpful when the sponsor is connected because they can directly monitor our site’s pre-screening and enrollment activities at any time and we don't have to consistently send them a typed-up log like they've required in the past. I think it's beneficial for both sides to be able to access data in real time.
Having sponsors connected cuts down the amount of recruitment-based emails, which reduces the bulk of unnecessary communication. And I like the option to upload the I/E criteria into the log section because then it's right there, so I don't have to think of it off the top of my head or go to another area and look it up—everything's right there, which is very convenient. The staff at [OneStudyTeam] was so helpful, they entered all of the criteria for all of our trials!
Is there a difference in your interactions with sponsors who are connected in StudyTeam versus those who aren’t?
When it's recruitment based, it's clearer to have the sponsor connected because they have all the information they need right there. Sometimes when it's a separate log, not all pertinent information is necessarily in one place. Communication is clearer when the sponsor's connected.
How does StudyTeam benefit your overall relationship with sponsors?
Instead of making a phone call to us or sending an email, the sponsor can go in at any time and see our recruitment status.
How do you measure success when it comes to recruitment and enrollment?
Success means getting eligible patients screened quickly and having them on study treatment as soon as possible. We like to have our patients happy and healthy. We put in a lot of work for recruitment. We have had more than 300 patient referrals for some studies. Our main focus is to have the patients qualify and, hopefully, have the treatment be successful.