When you partner with experienced and capable investigators and research teams, you’ll be able to execute your clinical study in the most efficient and cost-effective way possible. At the other extreme are studies that get mired in the weeds of site bureaucracy and inefficiencies. So how do you bring in the trophy sites and leave the weeds behind? In this BRIGHT Insights article, Director of Clinical Research, Melissa Ingram, PhD, shares five best practices for research site qualification.
Create your site requirements list
The first step in selecting sites is to define your wants and needs. To develop your site requirements list (aka wish list), we encourage you to obtain input from your medical advisors and your national principal investigator (PI), if identified. Beyond the basic requirements spelled out in the regulations, consider additional criteria including the site’s experience running studies in your therapeutic space and a site’s ability to
- use a central Institutional Review Board (IRB)
- negotiate a clinical trial agreement and budget before FDA has approved the Investigational Device Exemption (IDE), if applicable
- accommodate remote monitoring
Of course, it’s usually difficult to get everything on your wish list, so you’ll need to parse your needs from your wants and prioritize which of the latter are most important to your team. While some criteria are deal-breakers, like whether a research team is in good standing with FDA or an IRB, others are negotiable. For example, an enthusiastic, dedicated research coordinator with slightly lower site recruitment potential may be a preferable site to one with an overworked research coordinator swimming in cases and other studies.
Generate a list of potential sites
With your wish list in hand, start to gather site and investigator recommendations from clinical networks within your company as well as from your medical advisors, national PI, and clinical research organization (CRO).
Another creative idea to find experienced sites is to search the published literature and clinicaltrials.gov for studies on similar products, conditions, or diseases. This will help you find sites that are interested in and capable of doing similar work; it may also help you rule out sites that have an established relationship with another study that will compete for your patient population. Finally, medical conferences and meetings provide useful venues to gauge research interest.
Informally engage sites to determine interest
Before embarking on lengthy qualification surveys or arduous contract and budget negotiations with sites that might not be a fit, we recommend starting with informal PI conversations. Our team has found great value in meeting with potential investigators early to discuss the study at a high level. You can learn about the PI’s clinical research experience and the approach of his or her research team, and you might also gain beneficial feedback about your study design.
Another key takeaway from this initial engagement is that you will gain insight into how easy or hard it is to communicate and schedule time with the study personnel. If it’s a struggle to schedule 30 minutes by phone or the research team repeatedly misses your appointment, consider how likely it will be for those frustrations to continue throughout a study when you need to schedule and complete site initiation visits, training, and monitoring.
When you begin your site interactions with a simple conversation, it might be easy to forget one important formality that usually happens during contract negotiations: the non-disclosure agreement. Your legal department will be so pleased if you get a non-disclosure agreement signed before you share proprietary information about your company, product, or study.
Collect and process site qualification questionnaires
Now that you have cast a broad net to identify sites that were engaged during your meeting, ask those who expressed interest in participating in your study to complete a brief questionnaire that you’ve designed to specifically address your established criteria. Review their responses against the weighting of your criteria (the needs vs. wants and areas you are willing to negotiate as previously discussed), and request clarification about responses that are unclear. Prioritize the potential sites into those you prefer to work with along with a back-up list; these back-ups may come in handy if one or more of your first-tier sites falls out during contract and budget negotiations or if the PI leaves.
Dig deeper to understand site processes & efficiencies
Before you formally invite sites to participate, take time to learn about their specific approval processes and where efficiencies exist; perhaps equally as important, pay attention to their inefficiencies. Consider these questions:
- Do additional site subcommittees need to review and approve the protocol, subject screening, or other study details? If so, what are the timelines, and can the reviews take place in parallel with IRB review?
- Does the site use accelerated clinical trial agreement (CTA) templates, or will they accept your CTA template?
- Is IDE approval or even CMS approval required for contract and/or budget negotiation or contract execution?
Be proactive in formally qualifying your selected sites
When it’s clear you have a fish and not a weed on the line, set the hook by promptly executing your formal site qualification procedures. In our experience, many sites are willing to start the CTA and budget negotiations prior to IDE approval. This can be a huge timesaver, not to mention an adrenaline rush when you get to “flip the switch” on all those primed sites as soon as the IDE approval letter rolls in.
In summary, there is a sea of talented research teams at sites located all over the world. After you create a well-informed site requirements list, cast a broad net by having informal conversations with your preferred sites. When you identify capable sites that are interested, narrow your catch with a concise and strategically designed site qualification questionnaire, and dig deeper into site processes to understand their efficiencies, or lack thereof.
The excellent working relationship you develop with the sites during these preliminary engagements will help you catch fish instead of weeds, make formal site qualification a snap, and maximize the likelihood that your study execution is as efficient and cost-effective as possible.