New technologies and innovative companies within our industry have created an interrelated ecosystem that connects sponsors, patients, and research sites like never before. Our Krystle Buntemeyer sat down with Advarra’s Randall Hein and asked him questions about industry trends and the importance of strengthening that dynamic network across the industry.
What are the benefits of developing and strengthening an ecosystem that connects all these clinical trial aspects?
To be able to best serve the patients and achieve study endpoints and objectives, it is clear that stronger connections and transparency need to be a priority between the sites, study participants, and the trial sponsor. Ultimately, efficiency is driven by access to the data itself — how it’s gathered at the sites that are conducting the studies, how it’s monitored during the trial, and ultimately how it is accessed and reported from study startup through conduct to post-study analysis. As an industry, we are also becoming more sophisticated in how we use data before we even begin a trial. Real-world patient data, lab data, and social and behavioral data are being used to help design successful protocols, improve study planning and site selection, and accelerate the drug development roadmap to improve treatments and quality of life for patients.
What are some of the trends that are in sight — the ones that are either beginning to take hold or will very soon?
Obviously, trends are being shaped and accelerated as result of COVID-19, particularly in areas such as patient identification, enrollment and retention, safety, regulatory, operational oversight of studies, and the increased need for flexible or hybrid study designs that include aspects for both decentralized and traditional study conduct.
Just to take one example: One of the limiting factors to trial efficiency is the lack of use of consistent research technology and the challenges associated with interoperability and data exchange between disparate systems. Let’s say you have a study with 50 sites. Ideally, all 50 sites would use the same research technology and systems. This would enable greater accuracy and consistency in study setup, enhance transparency in overall study progress, allow for increased opportunities for intelligent trial monitoring, and improve regulatory compliance. However, in reality, many of these sites will use homegrown research technology — or no technology at all — which leads to inconsistencies and inefficiencies across the board.
To drive wide-scale adoption, research technology solutions need to be designed with the research site in mind. Systems that work for sponsors or CROs are often not site-centric and do not consider the specific challenges sites face, nor the nuances in the workflow of how sites actually conduct research. Also, while there have always been niche solutions that address certain aspects of clinical trial technology, newer systems are emerging that tie together tools such as the CTMS, eSource, eReg, and payment components into a holistic system. This integrated approach is likely to garner more adoption over the long term than one-off components pushed to the site on a per trial basis.
What else are you seeing as general trends?
One of the more important emerging trends I see is a move toward true patient engagement. Let’s face it, no new treatment can be realized without the generosity and selflessness of those who participate in clinical trials. Just as it is important to be site-centric in the research tools that we use, it is critical that we become patient-centric in our design and conduct of clinical trials. This means actively taking into account flexibility in study design and on-site requirements, implementing easy-to-use, patient-focused ePRO and eCOA research tools, as well as closer collaboration with and inclusion of the patient’s preferred medical provider in the clinical research process. Also, we need to make it easier for patients to find, enroll, and engage in clinical trials. As an industry, we have an obligation to do a better job of reporting outcomes and results to the patients participating in clinical trials and to actively share this information on social media and in partnership with patient advocacy groups.
How can organizations position themselves to be part of the emerging trends in research today and not be left behind?
Most importantly, be part of the solution. For example, Advarra has taken a very active role in compiling and sharing research and regulatory guidance in light of COVID-19. We’ve made our eReg Lite tool available for free to existing customers through the end of the year to assist with remote data access and we continue to refine our services and technology offerings to best serve the needs of our customers to accelerate and enhance clinical research.
While we are all specialists in the services we provide, it is important to recognize the value and importance you’re bringing to the overall research ecosystem. How can you streamline and make your offerings easier to use and more efficient for researchers and patients? How can you better contribute to the research ecosystem through data exchange or partnership with companies offering adjacent services? Get your message out there in a strong, clear way to make it easier for your customers to identify how you can best work together.
Where is the industry headed?
Certainly, and sadly, we’ve already seen what kind of changes need to take place to begin this transformation. At the beginning of 2020, we had no idea that COVID-19 was about to transform our world — and clinical research — the way it has. But in the long run, that change is going to be good for this industry. It pushed us toward innovative solutions like decentralized trials, better solutions for intelligent monitoring, and changed research in ways that are going to ultimately benefit patients. And that’s who we’re really doing this for anyway.