How and Why to Include New Sites in Your Clinical Trial

It’s no secret that sponsors usually have sites they prefer to work with or would rather go to – you can even check which sites a sponsor has consistently worked with on TrialHub. Typically, though not always, these are the popular sites where everyone wants to go. They can be popular in one or multiple indications and they have the experience to back up their status. 

However, as you know, depending on the indication, going to the most popular/experienced sites can also mean more competition at the site. Additionally, it can pose another challenge – a depleted patient pool. Both are likely to lead to delays in recruitment or even no recruited patients at the site. 

Let’s imagine now you’re a CRO expert and your team has come up with a strategy that includes less experienced sites that could, nevertheless, boost recruitment. How do you pitch this to the sponsor? It might actually be easier than you think.

Recruitment-related factors are pivotal, a study says 

A 2019 online survey investigated which site-related qualities multinational biopharmaceutical companies and CROs take into consideration during site selection. Despite what it might feel like at times, 75% of the participants stated that their company would be interested in working with an inexperienced site if the site had access to a large patient population. 52% reported that “their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment.”

What to make of these results? On the one hand, the study concludes that recruitment-related factors (like a site’s access to patients) are what matters most in site selection. On the other hand, a number of industry experts have shared their observations that less experienced sites often get overlooked.  

My interpretation (and feel free to share yours!) is this: on principle, a sponsor may prefer to work with the most experienced sites, equating experience with trial success. And true, it is a conservative industry – some old assumptions like ‘more experience = better results’ are hard to dispel. 

Yet, when it comes to patient recruitment, many sponsors would go to the less experienced site if this means exploring a new patient pool. 

As long as your clinical trial strategy makes sense and you can back up your site selection (something, by the way, TrialHub’s country advisors can help you with), only the most conservative or risk-averse sponsor will outright turn you down.

New sites don’t always stay in business long enough

A recent LinkedIn conversation sparked my curiosity. Why is it that, though new faces are needed, so many sponsors seem to be reluctant to give new investigators a chance?, Tammy Tate-Beaty asks in her post. 

The commenters share her observations that it is difficult for new sites to get involved in research, despite the industry’s need to reach new patients. 

“It seems that studies having problems with recruiting might later pick up less experienced sites if they’re desperate, but always seem to cling to the “tried and true” in their therapeutic area. It doesn’t seem fair. I’m a CRA and have spoken to my study teams in the past and recommended sites that were new but competent and reputable,” says Christine Sears, MSW.

Another comment expresses the hope that if sponsors start including less experienced sites in their studies, in time those sites will be comparable to popular ones. 

However, it might not be as simple as that. 

Maya Zlatanova (FindMeCure’s CEO) points out that running a site is “a complicated business which is not for every doctor and practice”. The balance between resources invested and ROI can be tricky and so quite a few sites decide to quit before they get the experience to truly compete with the big stars. 

Decentralization could be an alternative

Still, if you and your sponsor are committed to bringing the trial to new patients in order to 1) improve recruitment rates and 2) help patients with no previous access to treatments in research, there are a few other avenues. Decentralization could be one of them. 

And when I say decentralization, I don’t just mean VCT components like eConsent, ePRO, and remote monitoring devices. Decentralization can also mean the empowerment of local practices to participate in clinical research without necessarily becoming sites. 

This approach can be especially powerful in rare disease trials where patients are located all over and traveling to the site (even if reimbursement is offered) can be a huge obstacle to participation. 

Think of the protocol on a jobs-to-be-done basis. Are there exams that can be performed at the nearest clinic to the patient? Can you still find a way to comply with regulations and have the patient give blood samples in the lab near their home instead of the site? Is there a place near your remote patient that can offer ultrasounds? Or a hospital, other than the site, where regular check-ins are possible? 

If so, then you can design and amend the protocol around the eligible patients, not trying to recruit eligible patients around the protocol. It is a different way of conducting research and depending on your location(s) and circumstances might require more paperwork. But isn’t timely recruitment and helping patients the goal?

The rest can be figured out and hopefully, made easier by regulatory bodies. 

Site networks can diversify patient populations

Other than offering convenience by connecting a trial to multiple sites with a single point of contact, site networks can also diversify the study’s patient pool. How? By supporting new sites.

If new sites = new patients, yet running a site is a challenge that stops many, then relieving some of the burden on new sites can be a great solution. Site networks do this by providing resources, training, and even personnel so that new faces can have an equal opportunity to participate in research – and bring their patients along. Not only that but they also offer some credibility to less experienced sites. 

“This is the niche where I’m seeing site networks pop up and solve this gap for sites considered too ‘naive’ for whatever reason to satisfy big pharma,” says Edye Edens, Senior Research Compliance Consultant. 

Still, as a sponsor or a CRO pitching the idea, you need to have an answer to the question: Other than working with new sites, why should I go with a site network? After all, if new sites are what you’re after, there are other ways to discover them – KOLs, TrialHub’s network of country advisors, etc. 

Global site networks can give you access to multiple experienced sites through one central entity, which saves costs (and hassle) by reducing the total number of sites used.  

In conclusion

New, less experienced sites may be overlooked by big sponsor companies, despite their big advantage – providing access to new patients seeking treatment, thus helping them and supporting recruitment. The burden of running a site may be especially heavy on practices that are new in the space leading them to quit before gaining experience. 

Still, there are ways to take treatments in research to patients that because of their location have had no previous access. One possible avenue is decentralization where local practices are empowered to participate in research without becoming sites. Another approach is partnering up with site networks that often support new sites and provide the convenience of a single point of contact. 

If you are trying to discover new sites and reach new patients, our global network of local advisors can recommend organizations based on your protocol and priorities.

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