The goal of clinical trials is to make them more patient-centered, and new technologies such as portable devices, remote monitoring, and virtual clinic visits are helping to achieve this. Intervention trials aim to learn more about a particular intervention or treatment, and a computer classifies people into different treatment groups for comparison. Representatives from biomedical research, regulatory companies, pharmaceutical companies, academia, and other sectors have gathered to discuss the challenges that prevent clinical research from being carried out. The COVID-19 pandemic has provided an opportunity to see how routine clinical care and clinical trials can work together to generate evidence.
Digital approaches have improved the design and implementation of clinical trials, but their translation from clinical practice to clinical practice is still lagging in most areas of medicine. Over the next decade, machine learning, deep neural networks, and multimodal biomedical AI are expected to revolutionize clinical research from all angles, including drug discovery, image interpretation, streamlining electronic medical records, improving workflow, and eventually advancing public health. Five years ago, there were few Institutional Review Board (IRB) guidelines for researchers related to the use of technology in research studies. Disruptive innovation should make every clinical center a research center with all the necessary quality controls and research as part of the standard of care.
This combined with the inefficiencies and deficiencies affecting the healthcare system is causing a crisis in clinical research. Prior to the COVID-19 pandemic, clinical research had remained virtually unchanged for 30 years and some of the norms and rules of trial conduct were unquestionable. Digitalization, virtualization, and decentralization are not the cure for clinical research crises but they can generate efficiencies that can have a significant subsequent and long-term impact. This document provides an overview of the use of digital technologies in clinical trials and other clinical research over the past five years and lays the foundations for their application by interested researchers.
Data standards have been established by the Clinical Data Exchange Standards Consortium (CDISC) which created definitions, models, and specifications for data representation in research. Better clinical research should take advantage of knowledge acquired in each specialty to achieve a collaborative model that allows for multidisciplinary high-quality care and continuous innovation in medicine.