An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Developing new medicine and health solutions and
improving patient health currently rely on the successful execution of
clinical trials, which generate relevant safety and efficacy data. For
their success, recruitment and retention of participants are some of the
most challenging aspects of protocol adherence. Main barriers include:
i) lack of awareness of clinical trials; ii) long distance from the clinical
site; iii) the burden on participants, including the duration and number
of clinical visits, and iv) high dropout rate. Most of these aspects could
be addressed with a new paradigm, namely the Remote Decentralized
Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has
highlighted additional advantages and challenges for RDCTs in
practice, allowing participants to join trials from home and not
depending on site visits, etc. Nevertheless, RDCTs should follow the
process and the quality assurance of conventional clinical trials, which
involve several processes. For each part of the trial, the Building
Blocks, existing software and technologies were assessed through a
systematic search. The technology needed to perform RDCTs is widely
available and validated but is yet segmented and developed in silos, as
different software solutions address different parts of the trial and at
various levels. The current paper is analyzing the availability of
technology to perform RDCTs, identifying gaps and providing an
overview of Basic Building Blocks and functionalities that need to be
covered to support the described processes.