We seem to be entering a new phase of our world as we start the process of returning to normalcy from COVID-19 and enter an uncertain geopolitical future with the current conflict in Ukraine. One thing that is for certain is that healthcare (the way we know it) is rapidly evolving and advancing. Who could have imagined that we would have vaccines with mRNA technology developed, approved, and administered to billions of people in a few short years.
This evolution holds true for clinical trials as well. The recent trend of decentralized clinical trials has captured the industry by storm and holds a lot of promise. According to Mckinsey, more than 70% of potential participants live more than 2 hours from a potential clinical trial site. Decentralized clinical trials can allow people to participate without traveling to the site, expanding access and enabling more diverse recruitment for clinical trials.
However, it is important that we consider the patient experience through this process. One thing we have learned at Leapcure is the importance of clear, consistent, and reliable communication to build trust through the clinical trial recruitment process. As the Mckinsey article highlights, clinical trials are already unfamiliar for many people, and conducting clinical trial procedures virtually may not be successful due to differing levels of comfort with technology and clinical trials. These are also current challenges that we observe with clinical trials as well.
Patient education and support tools will be key to mitigating these challenges, now and into the future. Clinical trial sponsors and sites should focus on creating systems that focus on patient support, education, and building patient trust through human connection because this will be the key to creating more effective clinical trials.
Diversity, equity, and inclusion in clinical trials is an important challenge that will continue to be an area of focus in the future. As the industry explores decentralized trials, access and comfort with technology has most likely improved with the COVID-19 pandemic lockdowns but can vary greatly across the age and socioeconomic background of the patient. Relying more on technology to facilitate clinical trials without providing the proper access, support and training will continue to exclude certain groups from clinical trials and perpetuate systemic exclusion. Therefore, it is important to understand how the future of clinical trials will look from an equity perspective to ensure that the disparities observed in clinical trials can be corrected in the future.
It is a truth universally acknowledged that one cannot have clinical trials without patients willing to participate in them. Processes, regulations, technologies are all going to evolve and adapt as we go into the future. One thing that will remain constant is the need to focus on educating and supporting diverse communities of patients on clinical trials to create a future of better, more effective, and equitable clinical trials.
One thought on “The Future of Patient Centered Clinical Trials”
Working as a certified mobile research nurse, I see the positive affects of the decentralized clinical trial model. I had a patient yesterday told me that she has been requested to be in multiple studies over the years and that the one I was a part of which involved me traveling to her to conduct the visit at her home, was the only one that she agreed to continue participation in. This highlights the importance of the patient experience, as you note. From communication and education in recruitment, screening, enrollment as well as while the study is occurring, a focus on subjects’ needs is a crucial piece of conducting a successful trial. I believe a decentralized model with the focus on patient satisfaction markedly increases compliance and is a crucial piece of the puzzle toward conducting a successful clinical trial.