Clinical research trends include increased emphasis on study design: Advarra
The past several years have been dynamic for the clinical research industry, with changes and evolution in technology, regulation, increased emphasis on patient-centricity—to say nothing of the impact that COVID-19 has had. As vice president of research and strategic consulting with Advarra and an industry veteran with decades of experience, James Riddle has a unique perspective, which he shared with Outsourcing-Pharma.
OSP: Could you tell us a little bit about your work/role at Advarra and any accomplishments you’d like to brag about since you joined Advarra?
JR: As the vice president of research services and strategic consulting at Advarra, I am responsible for our biosafety (IBC), data monitoring (DMC/DSMB), endpoint adjudication (EAC), and GPS comprehensive IRB Office management services. I also work hands-on with our consulting clients on numerous projects.
What I’m most proud of during my time at Advarra is our smart and dedicated team of top talent who come together and provide comprehensive research oversight and services that make research smarter, faster, and safer. In the last year, we added the capacity for independent Data Safety Monitoring Boards and Endpoint Adjudications Committees. Advarra is no longer just an IRB company and it’s been such an exciting journey to get to this point.
OSP: What are some of the key milestones in the industry you’ve noticed during your career?
JR: Having worked in human research protections since 1998, we’ve seen a lot. Notably, over that time, there has been a shift to more centralized review and oversight of research. Be it single IRB (sIRB) mandates from NIH, or FDA guidance encouraging the use of independent central IRBs, acceptance and utilization of a more efficient review process have increased.
North America has one of the most efficient clinical research oversight systems in the world, and Advarra, whose focus on partnering with organizations to advance cures to market as quickly and safely as possible, plays a big part in that.
We are also finally seeing digital transformation take full effect with the last of paper-based processes being replaced by more efficient and accurate decentralized clinical trial methods. The industry has come a long way from filling out case report forms by hand on carbon copy triplicate forms.
OSP: If you could, think back to the industry in the months just before COVID landed. What were some of the key developments and concerns in the industry?
JR: Evaluating how best to incorporate real-world evidence and decentralized trial methods were top of mind just prior to the pandemic. COVID accelerated our adoption and trust in decentralized methods. From tech-enabled solutions like eConsent, ePRO, and other remote collection tech to improved use of telehealth and in-home visits during the clinical trial, the pandemic significantly allowed the industry to move the needle and demonstrate we can switch to decentralized clinical trials without sacrificing participant safety or data integrity.
We also validated what many in the industry felt was true for a long time – that moving to where the patients are, both physically and technologically, improves inclusion and participation in clinical trials. Incorporating virtual trial methods means we can now reach folks in more rural settings or those whose work schedules are not conducive to traveling to a research site.
Now we can do a televisit with remote collection and monitoring on the person’s own device and send a mobile clinical research nurse to their home when it is convenient for them. This change alone will significantly increase the diversity and access to research as we reach more people.
OSP: Please tell us what trends people should expect to see in the year ahead, regarding changes in study design
JR: Study design is going to be a huge focus in the year ahead. We're going to see continuing innovation from sponsors in how to make their trials friendlier for decentralized clinical trial technology. his is going to be the year we see changes in how studies are thought through, developed, and implemented. There will also be a big focus on increasing participant engagement and making clinical trials more accessible to all. While 'decentralized clinical trials' was the buzzword of 2021, this year will be about consolidating and focusing on participant-centricity.
OSP: What about siting of trials—do you expect an increase in studies located in the US and other areas offering diverse patient populations?
JR: This is the year sponsors will start to bring research back to North America. North America has the best and most well-defined regulatory framework for conducting human clinical trials. Combined with the overall increased interest in clinical trials, the US is a lot more appealing for research than it was even two years ago.
OSP: Then, please talk about public awareness. Specifically, positive press about vaccine trials has increased civilian awareness of trials; how do you see that developing going forward?
JR: There’s a responsibility scientists have in 2022 to continue spreading awareness about clinical research and encouraging the public to ask questions and get involved. When more people are aware and interested in participating in research, it makes these trials more effective and powerful.
It’s time to really bring participants into the conversation and ask what makes research accessible to you and then refine our processes from there. It’s so exciting to see people (even the younger generation!) much more engaged and knowledgeable about what’s going on inside research. It helps improve people’s general attitudes toward what this industry does.
OSP: Could you tell us how you see consolidation trending, and do you think entities like CVS’ clinical trial services will have an impact?
JR: In the last decade we’ve seen a lot of consolidation of health systems merging to create larger systems under a common administrative framework. In 2022, we can expect to see similar consolidation within clinical research sites. It’s also great to see that many of the clinical trial site networks forming have a very strong centralized administrative apparatus, which for someone from an IRB perspective or study startup perspective, this will result in faster startup and more consistent operations across the board.
OSP: Anything you’d like to add?
The future of research is very encouraging. It will be exciting to see what the next few years have in store and the team at Advarra is looking forward to continuing to support the clinical research enterprise to advance human health.
