How Can Disruptive Trial Models Help Us Meet Patients In The Real World?
By Bryan McDowell, global program lead, digital development, Novartis
When it comes to drug development, the pharmaceutical industry has long followed the same model for how we approach clinical trials. However, we are on the precipice of a new opportunity for the entire healthcare system in which emerging technologies can help us develop and deliver medicines to patients in more agile and efficient ways than ever before. Specifically, when it comes to clinical trials, we have a chance to reimagine the ways we study and develop new treatments, by leveraging new technologies to help us gather a better quality of data, while also designing more patient-centric models that can meet patients in the real world, where they are. It is time the industry begins to move toward new methods and more efficient practices. While there are many different tools and technologies being explored to enhance drug development, the implementation of novel trial models and settings will prove to be critical for continued innovation in the future.
These new “virtual” or “decentralized” trials utilize digital technology to enable some or all aspects of a clinical trial to be conducted outside the traditional clinical research center, at the participant’s home or in their local physician’s office. By using various decentralized trial models to bring an entire study, or the majority of its requirements, closer to a patient’s home environment, not only will a significant burden be lifted from the patient, but we also have the opportunity to democratize access to clinical trials like never before. And by doing so, we remove the largest exclusion criteria from our trials – the geographic barriers of clinical research centers -- thus opening the door to the 40 to 70 percent of patients who otherwise would not have access to traditional sites. While patient enrollment as a whole is a significant challenge, the industry has also struggled to reach specific populations such as older adults, minorities, and children. Through the use of remote participation models, there is much higher potential to reach these underserved and under-represented populations across the world. This could both increase access to potentially life-changing medicines for these patients and improve the quality of data we can secure, making our studies more representative of broader populations and helping us to learn more about the diseases and treatments we study.
This model has the potential to address some of the biggest challenges that currently hinder the performance of successful clinical studies. Take, for example, patient recruitment and enrollment numbers, which are at a critical low point. According to the Center for Information & Study on Clinical Research Participation (CISCRP), only 2 percent of the eligible population in the U.S. participate in clinical trials and 85 percent of clinical trials fail to retain enough patients in time to initiate the study. In addition, even when we do get enough patients enrolled to get our studies off the ground, participation in trials often requires approximately 11 visits to the trial site. This asks a lot of our patients in terms of the time and travel commitments they have to make in order to help further medical research.
In turn, these richer and more relevant data sets have the potential to further reshape the ways we design clinical studies. If we’re able to gain a deeper understanding of patient experiences and the effects of treatments using tech-enabled models, like real-time data capture available via sensors and apps, we can possibly reduce the number of patients required for a study. Designing clinical trials through this model will enable researchers to gather more high-quality data from a real-world setting in a minimally invasive manner. Further, researchers will be able to obtain insight into patients’ conditions as various symptoms or outcomes occur, which can allow researchers to provide medical oversight in real time.
At Novartis, we’ve seen the potential of decentralized clinical models through proof-of-concept trials in collaboration with Science 37. We’ve initiated early-stage studies using the virtual model for cluster headache, acne, and nonalcoholic steatohepatitis (NASH). From these early pilots, we’ve already seen ways to enhance the trial process from end to end. Through Science 37’s Network Oriented Research Assistant (NORA) platform, we’re able to expedite several aspects of trials, such as patient outreach, screening, electronic consent, randomization, and data collection.
We recently expanded our partnership with Science 37 to initiate up to 10 new trials over the next three years that will leverage varying degrees of decentralization, including a “meta-site” model. From this research, we hope to evaluate the impact decentralized trials can have on patients and the research process overall, while helping to scale up this technology into larger, global trials to evaluate the best ways of leveraging more decentralized methods.
Different barriers have caused nearly 80 percent of clinical trials to fail to finish on time, and 20 percent of these trials to be delayed for six months or more. Given there are so many factors that play a key role in a trial’s ability to be completed, there is a strong need to investigate how we as an industry can make improvements at every level of the process.
While there is still a long road ahead as we continue to search for the best ways to integrate technology into research and development, the use of decentralized trial models holds immense promise. Ultimately, the use of decentralized trials and other emerging technologies presents a major opportunity to enhance the industry’s ability to speed the traditionally lengthy, and at times tedious, drug development process and bring forward new innovative medicines to patients faster, while simultaneously improving the data we collect and the insights we can garner from a model more representative of the real world.
About The Author:
Since starting in the pharmaceutical industry over 20 years ago Bryan has held a variety of different roles across the Pharma landscape. Throughout this time, he has identified and pushed for the greater use of technologies to build solutions for smarter drug development programs and trials that reduce patient, site and sponsor burden while improving data quality and patient centricity, ultimately reducing development timelines to deliver innovative medicines to patients faster. His current position in Novartis as Global Program Lead for Digital Development brings him to the forefront of disruption innovation in clinical trial methodology. Bryan holds a bachelor’s degree in biotechnology from Dublin City University and an MBA from the University of Wales.