As the world looks at various improvements and challenges everyday on a wide array of subjects, improvements in technology is what catches everybody’s attention in no time. Technology – in terms of developing new devices and machines, or improving the functionality of existing devices and machines, and writing new computer codes – has influenced the life of humans. Do these technological advances or changes affect the way a clinical research in carried out?
Yes! The influence of technology is already evident in shifting from paper-based monitoring to computer based monitoring of ongoing trials. Advances in available technology have been found to ease the research monitoring cost, improve quality of data as well as patient safety. Patient engagement into a clinical trial and site adoption are the two most cumbersome processes of any clinical research. They have been currently eased with the use of clinical grade wearables including mobile sensors and devices which help in monitoring patients from the comfort of their home and at any time. Smartphone applications, interactive voice response systems (IVRS), computer vision, and cloud computing such as electronic trial master file (eTMF), electronic source documentation (eSource), and risk-based monitoring (RBM) are the other developments which have made clinical trials more patient-centric.
Technology is set to turn the tables in favor of ease of conducting clinical trials as well. Cloud computing in particular has enabled single interface to collect and transmit clinical data across multiple systems in different locations. It is estimated that the use of technology in clinical trials could lead to about 30% decrease in personal site monitoring. The overall improvements have made it possible for stakeholders in clinical trials to track up-to-the-minute progress in the ongoing trial, which was earlier a tedious task.
Data collection, analysis and management on ongoing trials, on a real-world basis, would help in gathering information at an increased speed, demonstrate the ability of each patient to be a part of a research, and also increase the speed at which a patient is recruited for a study. Availability of large data also facilitates discovering innovative therapies, identifying sub-groups of patients who can be provided right kind of treatment, grouping patients so as to identify biomarkers for a particular medical condition.
Not far behind are the breakthroughs in the field of biotechnology which has enabled development of molecules targeting a particular genetic sequence to cure the disease or disorder.
The main drawback in adapting technologies into practical application is the lack of regulatory encouragement. Drug regulators who lag in upgrading their skills to scientific developments could prove to be hard to convince on the records maintained. Other drawbacks envisaged include truthful and reliable responses from participants such as on consumption of the test drug; access to computers and technology; accountability to any variables in studies; and application of technology to all clinical studies.