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The current site selection process has left many research sites unable to realize their full potential, limiting their ability to deliver optimal results. However, amidst these enduring challenges, a shift in power is under way.
Today, large academic research centers receive the vast majority of trial opportunities, leaving countless other sites constrained by studies that don’t align with their strengths. It’s not uncommon for experienced and motivated sites to accept the majority of opportunities that come their way, even when it’s not the best match for their team and patients. This results in highly qualified sites underperforming across trials – not because they lack the ability to deliver results, but because they lack the power to be strategic and selective in choosing trials.
I am optimistic that the tides are turning in the clinical trial ecosystem. New tech solutions, coupled with heightened U.S. Food and Drug Administration (FDA) pressure on sponsors, are tipping the balance in favor of research sites, granting them the power to be more selective. It sounds counterintuitive to refuse opportunities when, in the current climate, many sites don’t have a guarantee for the next time they’ll be offered a trial. However, as we see the FDA diversity plans go into effect and a focus on community relationships takes the spotlight, the sites that see the most success will be the ones that are picky about which trials they take on.
Refusing wrong-fit trials doesn’t mean limiting opportunities, it means taking the reins and ultimately seeing long-term benefits like saving time, establishing a reputation as a high performer, building a robust track record for securing the right trials, and avoiding unnecessary challenges.
In my current role, working closely with both sites and sponsors on our marketplace, I’ve had the privilege of listening to the pain points and priorities of both sides. Based on these insights, here are three steps I believe will grant sites the power of being picky:
Step 1: Be proactive in defining your ideal trials
When faced with a new trial opportunity, getting the necessary details to make an informed decision is not only time-consuming, it’s incredibly rare. Sponsors often fall short in giving sites enough information upfront to enable confident decision-making. While sites may not have the ability to change this dynamic, they can take charge by proactively establishing criteria with their teams for identifying the right-fit trials.
How? By answering questions like:
- What do my local patients need most and when in terms of clinical trials?
- What types of trials and therapeutic areas do my Principal Investigators or Sub-Investigators have the most successful experience in?
- What needs and areas do I have the greatest patient population to support?
- Where could I contribute to the inclusion of underrepresented patient populations that would help sponsors achieve diversity goals?
- What protocol components have proven most challenging for my site in the past?
- What disease areas do I have the best community connections or programs to screen and recruit patients for?
Sites can confidently navigate trial opportunities to ensure they align with their strengths and needs.
The answers to these questions will be the compass to navigating the decision-making process more efficiently. Some sponsor criteria are absolute, so when the answers to these questions indicate a trial might not be the right fit, the decision to move on to opportunities that promise a more valuable use of the site’s time is made easier.
Step 2: Tell the full story
The traditional data sources sponsors have access to when selecting sites are typically limited to trial experience, historical performance, and staff CV details. Not only does this mean sponsors are making decisions without the full story, but also sites with rich community connections and experienced teams aren’t able to showcase the full scope of their strengths. New technology solutions, including Inato’s marketplace, are changing how sites present their qualifications to sponsors and putting the spotlight on important attributes like:
- Community engagement initiatives
- Unique local patient populations
- Adaptations and special programs for easier patient access
- Representation of your research team within their community
- Context around previous trials, capabilities, facilities, and staff experience
Sites that can communicate this information to sponsors will boost their opportunities in being selected, giving themselves an extra cushion of reassurance when turning down trials that don’t align and crucially transforming how sponsors view community-based sites.
Step 3: Stand out with diversity and community engagement
In light of the FDA guidance and pending regulations, sites’ community engagement is becoming increasingly vital in clinical research. Sponsors know that sites with longstanding patient relationships and a trusted, reliable presence in the area are the ones that shine in recruitment and retention, especially when it comes to underrepresented populations. At Inato, we’ve seen firsthand how sites with dedicated community initiatives stand out to sponsors and deliver outstanding trial results.
Some programs that have brought success to community-based sites on our marketplace include:
- Sponsoring local sports teams
- Hosting free physician Q&As, clinics, and information sessions
- Participating in core community events
- Collaborating with local nonprofits and community health organizations
- Joining local boards and volunteer organizations
(For more tips, our team at Inato created a free guidebook with strategies research sites can use to maximize their community engagement).
These initiatives reassure sponsors of the commitment research sites have to building trusted relationships with local patients and bringing them into research. Sponsors want to hear about these programs, so the more sites are able to share additional information about their community relationships, the more they can stand out to the sponsor and feel confident when applying to trials.
Making the decision to be picky won’t be easy, and the steps to building the confidence and protection to ensure it’s a sustainable decision require a team effort. Nonetheless, in the long run, sites that take these steps will see themselves and their teams succeed across trials that truly fit their needs, bringing the right opportunities to their patients and contributing to the development of innovative treatments.
Inato’s marketplace is striving to be a part of this progress. It is completely free for sites and gives them the chance to take these steps and be more strategic with which trials they bring to their patients. After signing up, sites gain access to top sponsor trials and have the opportunity to apply to the ones that are right for them, showcasing holistic attributes to stand out to sponsors and boosting their chances of getting selected.
Learn more and sign up at inato.com.