Small Site Needs in Clinical Trials
A small clinical trial site shares how they bring clinical trials to their patients, and what they need from sponsors to continue being able to do so. This article features Jim Hoehns, PharmD, research director, and Sarah Larson, clinical research nurse, both at MercyOne Northeast Iowa Family Medicine and Residency.
What are some topline challenges you’re facing in being able to offer research to your patients?
SL: One challenge we face is that we're not primarily a research institution. We’re also a community-based clinic, which has a different mindset than a traditional academic medical center. The people we work with in the hospital have other jobs and help us with protocols and activities. It is challenging to get those people up to speed and totally trained in the specialized requirements for research.
Another challenge is in scheduling the tests, procedures and infusions required with the appropriate staff and with the right patients. We’re a small institution. We set aside a specific day for specialized research tests, so everyone has to be available on that day, in order to help patients meet the small window of treatment.
What consistent hurdles do you face, from the protocol side, in running trials?
SL: It doesn't matter the protocol, for each new trial, we usually get 10 new log-ins. That is a massive amount of information and training for each new system. It involves duplicating efforts, and needing different types of documents for different websites. It’s difficult to train new people on systems when they didn’t start with the trial. Sometimes, we use the same system for two trials, but for two different purposes. It’s confusing for someone trying to learn. Additionally, there is time lost when passwords are forgotten, and time spent navigating new systems to learn it ourselves.
We would love to see sponsors finding a system that can house multiple aspects of the trial.
What is the ideal solution for your organization?
SL: We would love to see sponsors finding a system that can house multiple aspects of the trial. If they could downsize from 10-15 log-ins to 3-4, by using platforms that can clump activities together or relate better to each other, that would be extremely helpful.
What types of innovation are you looking for to help you conduct clinical trials?
SL: Anything that increases efficiency, and makes the trial easier to work with. Research has advanced so much, but somehow we still do things that are stuck in the Stone Age. We still do a lot of paper documentation because sometimes there aren’t a lot of ways to do everything exactly to a sponsor’s specifications, or the methods would be very expensive for us.
Activities like medication log changes or AE logs are hard to do electronically or clunky, so we still do paper for some items. There is double and triple documenting we do to ensure that data is located in every place that it needs to be located. Anything to reduce that would be great. It not only increases compliance, but it reduces the time it takes to do everyday things.
Decentralizing aspects of visits to reduce travel is helpful to us, because we’re in a rural Iowa setting. However, we have concerns around responsibility to accomplish or oversee certain things, when there are people involved who aren’t at our site.
What areas of decentralization would be the most useful for you?
JH: Offloading some of the recruitment activities would be helpful; centralized patient recruitment has become much more efficient over the years, with a higher yield. However, it underscores the importance of clean handoffs between the local coordinator and the centralized coordinator and the need for clear delineation of expectations and responsibilities between the two groups.
SL: Decentralizing aspects of visits to reduce travel is helpful to us, because we’re in a rural Iowa setting. However, we have concerns around responsibility to accomplish or oversee certain things, when there are people involved who aren’t at our site.
Where would you recommend more site-sponsor interaction?
JH: There is room for improvement in how sponsors gather input about the workings of the trial from the site level. Sponsors have internal metrics, but site feedback and experience feels like a bit of a vacuum. We can give feedback on how well the site monitor is working or the top challenges we’re facing for patient recruitment and entering data. There is additional opportunity for proactive trouble-shooting.
SL: It would be great to have some sort of portal to submit solutions and/or problems each site is facing with a particular protocol directly to the sponsor. A direct line of communication that would likely improve both site and sponsor experiences.
Sponsors have internal metrics, but site feedback and experience feels like a bit of a vacuum. We can give feedback on how well the site monitor is working or the top challenges we’re facing for patient recruitment and entering data.
What are patients asking for in their clinical trials that sponsors can fulfill?
JH: Patients want prompt results and information from their clinical trials. That information can lag occasionally beyond what is typically reasonable to wait for results.
One of our strengths as a site is how stable our community is; our dropout rates for clinical trials are usually very, very low; it's uncommon for us to have a patient that's truly ever lost to follow up. We attribute that to the relationships we have with patients. They are established with care at our clinic, or with a primary care physician in the area. The result is that if they have a problem with a protocol, they verbalize it instead of disappearing.