Wondering what’s next in the world of clinical research? Catherine Gregor, Florence’s Chief Clinical Trial Officer and the former Director of Clinical Research Administration at Vanderbilt, gathered this list of key trends in clinical research she noticed at ACRP 2022.
Keep reading to discover 4 trends you need to know about to prepare for the future of clinical trials:
1. Workforce turnover continues to be an issue.
The clinical trial industry has suffered from high turnover rates for years. A 2021 study found that Clinical Research Associates (CRAs) consistently have turnover rates between 21% and 29%. Research sites’ turnover rates are also skyrocketing: WCG said that many sites reported turnover rates of 50% in 2021.
The conversations at ACRP 2022 proved that staffing shortages won’t go away anytime soon. Many ACRP attendees talked about not having enough staff to start trials successfully. And in a separate article, Jessica Moehle of Huntsman Cancer Institute told WCG CenterWatch that sites often had anywhere from 30-50 trials in their backlog.
Why are turnover rates so high? Possible causes include:
- Heavy workloads
- Lack of recognition for skills
- Too little training or professional development
- Not enough opportunities for promotion
Fortunately, sites, sponsors, and CROs are all looking for creative ways to solve this problem. Some options brought up at ACRP include:
- Offering remote work where possible
- Training a new generation on the potential of careers in research
- Providing training through organizations like ACRP and SOCRA (and Florence!)
- Offering user-friendly, intuitive technology
- Setting up standardized paths for promotion and career growth (though it’s still unclear what these would look like)
To learn more about workforce turnover in clinical research, check out these articles:
2. Tech is here to stay.
Most ACRP attendees agreed that tech now plays a vital role in clinical research. But they also agreed that the clinical research market is being inundated with tech solutions from all sides, with dozens of companies competing for business from sites, sponsors, and CROs.
This buildup of technology creates additional work for clinical research professionals. 42% of research sites say they have to log into 5 or more electronic platforms for an average study.
ACRP attendees agreed that sites, sponsors and CROs need to work on seamless data flow, but couldn’t agree on what that means. For example, some tech vendors argued that standardization of the eISF is the key, while other argued for greater customization of the eISF.
Tech vendors also don’t agree on whether a sponsor-focused, “site portal” model or a more site-friendly “eISF with remote access” model works best for sites and sponsors. (Florence favors the second model.)
Long-term, technology vendors need to provide integrations so clinical research professionals can log into fewer systems while still successfully completing their work.
We cover more about site, sponsor, and CRO tech in these posts:
3. Trials need to become more patient-centric.
Another sentiment nearly everyone at ACRP agreed with: clinical trial teams need to take research to patients instead of making them come to us. This will mean focusing on novel, patient-friendly tech, but it will also mean bringing clinical trials to more patients’ communities.
Clinical trials have very low consumer satisfaction scores, as low as the scores of utility companies, Internet service providers, and health insurance companies. This low customer satisfaction leads to slow recruitment and problems with patient retention. 45% of UK sites and 80% of US sites need extensions to meet their recruitment goals.
So how can we make clinical trials more appealing to patients? Research leaders and patient advocates at ACRP suggested the following strategies:
- Creating patient advisory boards to provide input on protocol design
- Seeking participant feedback throughout the trial
- Making sure all participant technology (wearables, ePRO, eDiaries, eConsent) is intuitive and accessible
- Holding trials at local sites closer to patients’ homes, like pharmacies and clinics
Since 42% of patients avoid clinical trials because of the inconvenience of travel, incorporating at-home technology or moving visits closer to patients’ homes could make a tremendous difference in patient recruitment and retention.
Bringing clinical trial sites to underserved communities could also make trials more diverse. Many patients, especially low-income patients, can’t afford to take off work or pay for childcare to travel to research sites hours away from their homes. They may also rely on public transportation, which makes it difficult to reach trials in other cities. Bringing trials to more people’s neighborhoods will make them more inclusive.
You can find more about participant engagement and patient-centric trials here:
4. Data privacy and regulations remain top of mind.
Clinical research professionals always care about compliance, and that held true at ACRP. But clinical research organizations are also becoming more concerned about data privacy as an issue separate from compliance.
Laws like HIPAA, GDPR, and CCPA have made cybersecurity a vital component of clinical trials. Clinical trial sites, CROs, and sponsors need to have a data security plan created in cooperation with each other, technology vendors, and IT staff. They may also want to look for vendors with third-party data security reports, such as SOC 2.
When it came to regulations, the most popular topics at ACRP were:
- The FDA updates encouraging remote monitoring and replacing over-the-shoulder access for monitors with remote access (already in effect at ACRP)
- The new EU Clinical Trials Regulation (recently in effect as of ACRP)
- The proposed UK clinical trial regulations (not yet in effect as of ACRP)
For clinical research professionals striving to keep up with constantly changing regulations, it’s important to regularly check data privacy and compliance resources. Check out the following Florence resources if you’re thinking about data privacy:
And consider these resources if your team is more worried about regulations:
- FDA eSource and eRegulatory guidance
- FDA 21 CFR Part 11 guidance
- Are Clinical Trial Teams Prepared for ICH E6(R3)?
- 9 Facts to Know About ICH E8(R1) If You Run Multicenter Trials
- How the New EU Clinical Trials Regulation Will Impact Sites and Sponsors
- What do the proposed changes to UK clinical trial regulations mean for you?
The good news? Though all of the regulations can feel overwhelming, most of them are aimed at making trials more efficient by streamlining protocols and emphasizing international collaboration. In theory, this should allow sponsors and sites to complete trials more quickly and get more approved treatments to market.
Carrying ACRP 2022 Trends Into the Real World
While it’s easy to get excited about trends while at a conference with like-minded people, it’s harder to carry that excitement back to your daily, often overwhelming workload. So how can clinical trial professionals keep what they’ve learned at ACRP alive?
We can start by setting aside a little time each day to brainstorm. How do we reduce burnout? What kind of technology do we need and what kinds do we not? How can we make trials more convenient for patients? What do new regulations mean for our plans to embrace technology, think about patients, or use remote monitoring?
By staying curious and continuing to learn about clinical trials, we’ll all become better–and more impressive!–members of the clinical research community. And speaking of trends, you can sign up for the Florence newsletter if you’d like to stay on top of the latest trends we’ve noticed.