Your potential investigator / KOL is very enthusiastic to do your study but does not have an experienced research team, or no study team at all. But he is the only one who has sufficient product usage to conduct a retrospective PMCF study. What do you do?
If you have experience with conducting clinical trials at a device manufacturer, odds are that you have had your close encounter with the research naïve study site. The research naïve study site features an enthusiastic clinician, who promises he or she has plenty of time after hours to enter study data into your “system”. Maybe they even have a secretary or student at their disposal who can “take care of the paperwork”. Reasons to go for research naïve sites can be many. Including the need for specific patient populations or real-world patient populations, geographical spread, product usage (in case of retrospective studies for example), the medical field you are operating in. If you find yourself with no other option than to contract the research naïve site, how do you prevent failure? And is there even the possibility of success?
The problem with research naïve sites
Even for the most seasoned research sites, any clinical trial is a challenge. Trials involve a huge administrative burden, different procedures, data capture systems, and sponsor peculiarities, establishing communication channels, building relationships, and freeing up time from personnel in an already busy environment. A site needs time, man-hours and experience to take on such a task.
Naïve sites underestimate the time commitment and lack of dedicated research personnel. If your investigator decides to assign study-related tasks to his or her regular daily staff, such as nurses, resident students or even secretaries without understanding the workload this represents, you will soon be faced with underperformance. The site’s lack of experience is likely to lead to non-conformities which will take a lot of resources to address. When this happens, initial enthusiasm at the site can quickly turn to disappointment.
If not managed properly, you risk entering a downward spiral of dropping enrolment rates, non-conformity pile-up and communication issues. Sometimes the situation can be repaired, other times the site needs to be abandoned. On the Sponsor’s end, the trial budget and timelines suffer the consequences and the relationship with the investigator - often also a customer - gets damaged.
Tips for success
First of all its probably best not to use those sites for critical or high-risk trials, but a less complex, low-risk study such as a retrospective data collection or observational post-market clinical follow-up study may have a chance of success when the following is taken into account:
- Manage expectations: Tune down the initial optimism, draw a realistic picture, perhaps even slightly pessimistic. You want to test commitment and prevent a disillusioned site further down the road. Set realistic goals for the site (this includes managing your own expectations).
- Allocate additional resources: Plan for additional time to guide the site, allow for extra training, monitoring visits and regular phone calls with the study team.
- Optimize your design to reduce risk: pay extra attention to the study setup and documentation. Keep it simple. Plan an extra monitoring visit after enrolment of the first few patients, slow down enrolment or use gated enrolment.
- Focus on compliance: know what are common findings in site audits, these items are likely to need extra attention at your research naïve site as well.
- Do not start a study without a site coordinator: this is your main contact on-site. Without a coordinator, no study. Consider hiring an external coordinator or collaborating with a coordinator from another hospital department (oncology, endocrinology). Consider resident doctors, secretaries or nurses if needed.
- Select the right monitor: the monitor should be the site’s main point of contact. Make sure you assign an experienced monitor who ideally has experience with naïve sites, who is patient and a good trainer. The monitor should be aware of the risks: protocol noncompliance, potential GCP breaches. The monitor should be prepared to repair, know how to handle issues properly and to not over-escalate.
- Focus site training: you need a solid training plan. Focus on the most important and practical aspects of a study. Train specifically on good documentation practice, informed consent and site logs. Present the site with some case studies as part of the training. Plan multiple training moments.
- Allow sites to learn from each other: in multicenter trials, organize opportunities for the naïve sites to learn from more experienced sites by engaging them together in training sessions, investigator meetings and project calls. The questions that experienced sites ask during such contact moments can be eye-opening for less experienced sites. Send regular newsletters to all sites that include “lessons learned” and reminders.
- Build trust: work on a personal relationship with the site. Make sure they know they can call you any time and no question or concern is too much.
- Prevent information overload: adapt your site training materials, limit automated and manual emails to site (query trackers, etc.), run all communication through a single channel: the monitor.
Conclusion
Even when you are working with a dedicated academic research team that runs complex premarket studies around the clock, managing a clinical trial is always a challenge. Research naïve poses additional challenges due to lack of experience and often resources. But everyone starts somewhere, and research sites are no exception. If you are willing to spend the additional resources to prepare, train and guide the site you may be investing not only in a good outcome of the study but also in a rewarding, long-lasting relationship with the site. You give them a chance to prove themselves and they may turn out a very grateful advocate to have on your side.
What can Qserve do for you?
We are a medical device dedicated CRO and we have experience with research naïve sites. Next, to our standard CRO services, we can provide customized site training and can help with site selection. We pride ourselves in our pragmatic approach. Take a look at our CRO page for an overview of all our services.