Over the past few years, the decentralization of clinical trials has gained much attention. Unlike traditional clinical research, decentralized trials use different technologies (i.e., wearable medical devices) and approaches (i.e., telemedicine) to recruit and retain participants and minimize barriers to participation by utilizing a more patient-centric perspective.
Digital transformation has become necessary for patient engagement and recruitment. It is directly linked to the rising costs of launching a new drug and the overall length of clinical trials, making them time and cost-consuming.
However, there seems to be little adoption. Clinical trials are taking baby steps when it comes to embracing modernization due to lagging global standards, and this is the main issue that must be addressed as soon as possible.
According to global data analysis research, the decentralized trial technologies (DLT), digital therapeutics, and much more must are opportunities to improve patient health.
A number of digital technologies can help the realization of the clinical trial management process, including:
However, clinical trial management teams must understand and negotiate numerous technical and ethical issues to incorporate these technologies into their processes and ask patients to trust them.
Are Patients and Clinicians Embracing Digitalization at the Same Pace?
Patients have long been reluctant to embrace digital technologies as part of clinical trials. They have been uncertain about the trustworthiness of these components and if they are used ethically. Fortunately, the situation is changing for the better. Consumer-oriented digital health products and services, such as wearable technologies, smartphone apps, and social media-based disease support groups, have started to change patients’ expectations of the healthcare industry.
A survey conducted by Deloitte in 2018 showed that 92% of 650 patients said the healthcare and life sciences industry should prioritize improving patient experiences (through innovative technologies), compared to 71% in 2017.
Wearable technologies demonstrate that patients are embracing digital technologies. This is what the numbers say:
Digital therapeutics, wearables, and other biosensors allow patients to take care of their wellness and health in a way they have never been able to do before. They offer benefits such as:
Despite all the advantages of using digital technologies and DCTs, it will take time until patients and clinicians fully accept them. Scientists and clinicians must evaluate which healthcare technologies should be trusted and integrated. However, to address and eliminate these uncertainties in the application and technology, clinical professionals and patients must work together to develop global industry standards.
One might question the importance of global technical standards and their role. They ensure seamless global connectivity, and once established, there would be no doubt whether that technology is validated, whether it will protect a patient’s privacy, and whether it will be compatible with clinical trial databases. However, it will take some time until it becomes a reality.
Therefore some clinicians turn to policy and regulatory bodies for guidance regarding integrating digital health tools into clinical trials. Others turn to global standards development organizations (SDOs) that bring together experts to develop solutions cooperatively.
Standards are essential for addressing many ethical concerns regarding patient data governance, securing data from the device to the cloud, and protecting patient privacy. All stakeholders – clinical professionals, technologists, contract research organizations, and patients – must be involved in building consensus and developing global standards.