By Ed Miseta, Chief Editor, Clinical Leader
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The East Coast Institute for Clinical Research (ECIR) is a site network with five offices throughout the Northeast Florida and Georgia conducting clinical trials across several therapeutic areas. Rebecca Goldfaden, VP of clinical operations for ECIR, has worked with more than 80 sponsor companies during her career in clinical research. She is a pharmacist by trade but has a post-doctoral fellowship in clinical research and has been involved with trials for almost 10 years.
I interviewed Goldfaden to get her perspective on clinical trials in 2020, where we currently stand, and what she believes sponsor companies need to do if they truly want to become a sponsor of choice for clinical research sites. She notes COVID brought a lot of challenges to the world of clinical research, but the industry is in a good position to incorporate change for all stakeholders.
Ed Miseta: Looking back at the changes that resulted from the pandemic, what are a few of the challenges sites have faced?
Rebecca Goldfaden: We certainly had to adapt to using different systems, which has some pros and cons. For example, many sponsors stopped allowing monitors to travel to the sites, replacing those visits with remote monitoring visits. Unfortunately, these have created additional work for site personnel. Monitoring visits were already time-consuming prior to the pandemic, but now sites must scan and upload documents to various systems prior to the remote monitoring visit. The sponsors that have been the best to work with are the ones that were proactive in reaching out to sites to provide systems to assist with remote monitoring visits and additional financial support. For us, that was one thing that made sponsors stand out during these difficult times.
Miseta: Did you have many sponsors reaching out to you to provide financial or other assistance when the pandemic hit?
Goldfaden: Last year was an interesting time for most sites. Early on we reached out to most of our sponsor companies and asked if they could release the hold back payments. Only one sponsor proactively did that for all sites on their trials. That was disappointing because that is payment for work that was already performed and could help sustain sites in a difficult financial position. For many sites, releasing that money would help ease the burden of continuing their studies. Months later we went back to the sponsors and asked for payments for the remote monitoring visits we were performing. Most of them denied that request as well except for one or two sponsors that proactively reimbursed us for remote monitoring visits we performed. A few weeks ago, we reached out to sponsors with that same request and so far, all sponsors have accepted it.
Miseta: Did it just take some time for them to realize you needed help continuing their studies?
Goldfaden: I think that shows sponsors now understand this situation is something that's not going away. Studies are more time consuming. The time we are spending scanning and uploading information and working with monitors in a remote fashion could be spent somewhere else. I was pleasantly surprised to see that sponsors are now accepting that request.
Miseta: CRA turnover seems to be an ongoing issue in the industry. Does that cause hardships for sites?
Goldfaden: Monitor turnover is definitely a challenge. We enjoy working with sponsors that have their own in-house monitors. The main reason for that is turnover. Over the past five years the turnover in monitors has gotten worse. That causes a lot of confusion and frustration for sites, since monitors may not be as experienced with the trials. Turnover can also cause a lot of disruption to the study workflow.
The level of turnover is certainly not the same at all pharma companies and all CROs. However, we have one sponsor company where I have been working with the same monitors for seven years. That tenure allows them to understand our processes, our source documents, and our quality standards. They get to know our investigators and our site. That allows us to better work together as a team. When there is a lot of turnover, it’s a frustration at the site level.
Miseta: Do you believe the turnover problem is due to an industry shortage of experienced and qualified professionals?
Goldfaden: That’s part of it. I have read articles about that, and I do realize some monitors will jump across companies due to better offers. But I believe a primary reason for turnover is reorganizing. Companies do not want a monitor to have too many studies and sites. Once a monitor gets more studies and sites in a certain area, some of the work will be reallocated. I believe that realigning and reallocating of the studies causes a good amount of turnover.
I do feel the quality of monitors has also changed. There is a huge demand for monitors. Years ago, someone had to have a certain number of years working as a coordinator or in clinical research before they could become a monitor. Because of the increased demand, we are seeing more monitors who do not have the experience you would expect. That can cause relaying incorrect guidance and more frustration for the site personnel.
Miseta: What challenges do you face related to patient recruitment?
Goldfaden: Trial recruitment is obviously a primary task for clinical sites. It’s also an important and expensive area for sponsors. When it comes to recruitment, handwritten prescreening logs are a personal pet peeve. This is an area of recruitment that can be time consuming and cause a lot of site frustration. If a sponsor asks for a handwritten prescreening log, the site might have to go through hundreds of patients and document them on the log. But I often wonder what the sponsor is doing with that prescreening log. I have no idea if anyone is actually reading it, typing it up, and reviewing the data. They are very time consuming and I really feel those logs are not useful to the site or the sponsor.
Miseta: Is there a better solution?
Goldfaden: One tool we have started using is Reify’s StudyTeam. It’s a solution we use to meet and even exceed our enrollment goals. It’s basically a user-friendly platform that helps us keep track of patients. While you might have one person working on the prescreening log, there can be multiple site staff in different locations managing recruitment using the StudyTeam platform. One of the benefits for sponsors is they can see our recruitment efforts in real time. That capability also allows us to eliminate many of the weekly calls and emails that request recruitment updates.
Miseta: Every site must work with multiple sponsors and, therefore, multiple systems. How much of an issue is that for site personnel?
Goldfaden: It’s definitely a challenge. Sponsors are focused on their trials and goals. But most sites work with numerous sponsors. When a sponsor or CRO comes up with a new solution that they think will help them, it’s another system that sites must add to their dashboard. One of the nice things about StudyTeam is that we can use it for every study, regardless of sponsor company. Sites could definitely use more solutions that can be used across all studies as that streamlines the process and simplifies their life considerably.
Miseta: In 2020 every trial seemed to convert to a decentralized model very quickly. How much of an issue did that end up being for clinical sites?
Goldfaden: There are a lot of systems out there that sponsor companies are using for a hybrid decentralized model. That means new systems, additional training, and more log-ins. Luckily, we were doing some of that pre-COVID, but that was definitely another burden to the sites.
Miseta: I attended a summit a few years ago for site personnel and was astounded by the number of sites that struggle with slow payments from their sponsor partners. Is that still a big issue for sites?
Goldfaden: It’s an issue and I have been to site solution summits where that has been a huge topic of discussion. We have sponsors who pay us monthly but there are also companies that pay in 60 days or 90 days. You can see why that would be a problem for sites that do not have several month’s worth of working capital on hand. We work with approximately 30 sponsor companies right now and I believe two of them pay us monthly. A few others pay within 60 days. Most sponsors still seem to prefer to pay their sites quarterly.
Miseta: Anything else you’d like to mention?
Goldfaden: As long as we’re discussing payments, I’ll mention one additional site struggle. Sometimes the requests for additional supporting information on invoices can be frustrating, especially for our financial team. It used to be you performed a service and got paid for it. Not anymore. Now it seems they ask for a lot of additional information. For example, we might invoice for a serious adverse event (SAE) and the sponsor comes back and ask for numerous other details. If that information is not on the invoice it will be rejected. Sponsors will require sites to do a lot of work just to get paid for tasks they have already completed. That does not make the site’s jobs any easier.