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Too Many Trials, Too Few CRAs: Closing the Capacity Gap in Clinical Trials

Too Many Trials, Too Few CRAs

The clinical trial industry has experienced 5.8% annual growth year over year–but the growth in Clinical Research Associates (CRAs) and research sites isn’t keeping up. 

To accommodate the number of trials predicted in 2030, Florence estimates that Contract Research Organizations (CROs) will collectively need to add 18,000 research sites to their networks. But as they add more sites, CROs will also need to add more CRAs–up to 20,000 more. 

How can we close these capacity gaps, when most sites already have more trials than they can handle and there are ongoing CRA shortages? We must innovate.

Keith Wright, MBA, CCRP, formerly of Indiana University School of Medicine and Eli Lilly, shared the following strategies for closing the capacity gap:

  • Make sites more efficient
  • Start up and manage frontier/community sites
  • Speed up CRAs’ workflows

Keep reading or check out our full webinar recording to discover how your Contract Research Organization can implement these strategies and become the CRO of choice for study sites and sponsors.

1. Make sites more efficient

CROs can reduce site shortages by making the sites they have more efficient. Sponsors often ask CROs and sites to work with limited budgets while maintaining:

  • Data integrity
  • Patient safety
  • Study speed
  • Operational transparency
  • Diversity of participants

Efficient, compliant site access software can help CROs constantly monitor their current sites and improve all of these areas. 

Data integrity

Site access software can cut down on data integrity errors through continuous monitoring. CRAs can view sites’ documents and data online every day instead of waiting for a site visit. This allows them to catch errors much sooner. 

Patient safety

If a Serious Adverse Event (SAE) occurs, the site can record it online and the CRO can review it and address it instantly. 

Study speed

Look for remote monitoring software that gives sites their own electronic Investigator Site File or electronic Trial Master File. Having this software at each site leads to 40% faster study start-up times

Operational transparency

Site access software provides real-time visibility into a site’s operations. If a site is falling behind, your CRO will know right away and can step in to intervene. 

Diversity of participants 

One way to improve the diversity of clinical trials is to expand the sites where trials are held. Remote access software gives CROs access to what we call “community” or “frontier” sites. 

Check out our full webinar recording to learn more about the importance of frontier sites.

2. Start up and manage frontier/community sites

Many CROs work with the same academic medical centers (AMCs) over and over again. These sites often have an experienced staff and abundant resources, which makes them reliable trial partners. 

But there aren’t enough large, experienced sites to manage the rapid growth of clinical trials. And many of these large sites can only serve patients who live nearby or can afford to travel. 

This leads to a lack of diversity in clinical trial participants, a major concern for many trials that became even more pressing with the FDA’s new diversity and inclusion guidance. One way to improve this lack of diversity? Bringing clinical trials to new, community sites near where underrepresented patients live. 

Frontier or community sites could be: 

  • Pharmacies
  • Local physicians’ offices 
  • Clinics
  • Labs
  • Homes (with home health services) 

Some CROs hesitate to work with less-experienced sites because they’re worried about data integrity or patient safety. This is why remote access software is so important. 

CROs can give eISF or eTMFs to new community sites. Then, the CROs can continuously monitor the sites, offer guidance and oversight remotely, and keep an eye on site operations. 

However, this strategy will only work if the software is easy for community sites to implement and use, even with limited staff. This is why sites should only invest in technology with proven site adoption and positive reviews from sites

To learn more about the right site access technology for your CRO, listen to our full webinar recording.

3. Speed up CRAs’ workflows

Increasing the efficiency of current sites and bringing in new frontier sites will help CROs overcome the site shortage. But how do they overcome the CRA shortage? 

The answer is simple: help the CRAs you already have do more work in the same amount of time. 

How can CROs pull this off? Keith Wright recommends three strategies:

  • Limit travel with remote check-ins
  • Provide all-in-one dashboards with alerts, tasks, and quality reports
  • Look for software CRAs already like to use

Limit travel with remote check-ins

Before the pandemic, CRAs spent roughly 20% of their time driving or sitting on planes. By cutting down on the time CRAs spend traveling, remote monitoring software can give CRAs back approximately 50 days per year. 

CRAs will still visit sites in person occasionally–but they can spend that time doing in-depth checks of the site’s safety and efficiency instead of sitting at a table and reviewing documents. 

Provide all-in-one dashboards with alerts, tasks, and quality reports 

Remote access software gives CRAs the ability to review regulatory documents and source data online. But it can also help CRAs do deeper work. 

CRAs deserve remote access software that includes “at a glance” dashboards. These dashboards can show upcoming tasks, urgent alerts, and quality reports for how sites are performing, all in one location. 

This clinical trial tech helps CRAs at busy CROs evaluate where to focus their attention each day instead of jumping from site portal to site portal. 

Look for software CRAs already like to use

Technology won’t always make CRAs more efficient. After all, most CROs already provide their CRAs with multiple technology systems, and all those systems can become overwhelming. 

That’s why it’s key to search for software that both sites and CRAs like to use. Look for CRA adoption rates and positive CRA reviews before choosing a remote site access solution. 

Florence estimates that with CRA-friendly technology, the number of needed CRAs in 2030 could drop from 300,000 to 150,000. 

If you’d like to hear more about CRA-friendly technology, watch the recording of our webinar with Keith Wright, MBA, CCRP.

Closing the Capacity Gap by Making CROs More Efficient

If all CROs stick to the way they’ve traditionally operated, it’s unlikely they’ll be able to generate enough additional sites and CRAs to handle the rapid increase in clinical trials. 

22% of Phase III clinical trials fail not because the drug is ineffective or unsafe, but because trials drag on for so long that sponsors run out of funding. If we can’t close the capacity gap for sites and CRAs, this number could continue to rise, depriving patients of life-saving treatments. 

The good news? We can use a variety of innovative strategies to speed up clinical trial timelines, from recruiting new community sites to making CRAs more efficient with remote access technology. CROs just need to try new ways of working with sites instead of relying on traditional, solely in-person methods. 

For more on how you can make your CRO more efficient, check out the full recording of our webinar on the CRO capacity gap.