Clinical research organizations use a variety of technologies to monitor patient compliance during clinical trials. These include “smart pill packs”, portable devices that transmit data to centers, and remote monitoring and interaction applications that patients can use through smartphones or other devices. The key challenges of clinical trials facilitated by technology are faster recruitment and better retention, improved patient experience, improved patient data capture, access to non-traditional data sets, and remote patient monitoring. In addition, the challenges posed by the new normal caused by COVID-19 can be addressed with innovative technologies. In this perspective, I share my heuristic vision of the future of clinical trials and test generation and reflect on the main areas that need improvement in the areas of clinical trial design, clinical trial performance and test generation.
Clinical trial training must also be part of medical education, so that a diverse group of researchers and trained staff from across the healthcare enterprise can be available for clinical research. Over the next decade, the application of machine learning, deep neural networks, and multimodal biomedical AI is poised to revolutionize clinical research from every angle, including drug discovery, image interpretation, streamlining electronic medical records, improving workflow and advancing public health. The industry's leading clinical trial management systems are built through collaboration with top-tier research centers. New methods for generating evidence of clinical benefits can accelerate clinical trials and provide people with rare diseases with access to new therapeutic compounds. The COVID-19 pandemic has created an opportunity to look at how routine clinical care and clinical trials can work synergistically to generate evidence.
Patient data is critical to clinical trials as it informs research directions and final clinical results. To achieve this, traditional clinical research models should give way to cutting-edge ideas and trial designs. Innovation and growth have led to the increasing adoption of portable devices in the clinical sector and during the COVID-19 pandemic, the technology has proven invaluable for the continuation of vital clinical trials. Wearable devices and other types of sensors can also be useful as tools for assessing compliance with a study protocol. Regardless of the new treatment objectives, evaluation criteria and trial designs being used, what matters most to regulators is clinical importance. A Clinical Trial Management System (CTMS) is responsible for managing all operational aspects of a clinical trial from start to finish.
Novel and innovative technologies have advanced exponentially in recent years, and the clinical trial landscape is changing rapidly as trials become decentralized and include more remote elements. Real-world data and real-world testing are increasingly important for clinical trials, and the ability of portable devices and associated technologies to collect and store large amounts of patient data has proven invaluable to researchers. Supported by grants from the National Institutes of Health (NIH) of the United States (R01CA242845 and R01CA27316), the Department of Cancer Therapeutics in Cancer Research at MD Anderson is supported by the Texas Institute for Cancer Prevention and Research (RP110058), the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Oncology Therapy (1U01CA18096), NCATS (Center for Clinical and Translational Sciences) (UL1-TR00037) and MD Anderson Cancer Center (P30CA01667).
