Risks To Sponsors Developing And Running Their Own DCT Technology

It is almost cliché now to mention that the COVID-19 pandemic was the proving ground for Decentralized Clinical Trials (DCTs) – the perfect catalyst to accelerate their development and adoption. With site and participant experience backing the benefit of DCTs, there is an understandable push by sponsors to scale remote research among their portfolio of clinical trials. To keep up, many sponsors are considering building their own, purchasing, or licensing DCT technology.

Both the DCT technology and the manner in which it is operated and configured should be carefully considered to ensure DCT technology meets the requirements of the International Council for Harmonisation-Good Clinical Practice (ICH-GCP, or GCP for short) guidelines, privacy laws/regulations and applicable clinical trial regulations.

Indeed, the stakes for getting DCT right are high. For example, although not the focus of this paper, handling personal data of residents of the European Union (EU) in a manner that does not meet the General Data Protection Regulation (GDPR), Regulation (EU) 2016/679 standards for processing personal data of residents of the EU could result in penalties ranging from warnings to fines, as well as loss of reputation and damage to business relationships. Failure to conduct the trial in accordance with GCP and/or clinical trial regulations could result in data that is not adequate to support applications to regulatory authorities. This article discusses those considerations and how a sponsor can ensure it exerts appropriate control over the DCT technologies that support their DCTs in compliance with ICH-GCP, the GDPR and similar laws, regulations and guidelines.

As sponsors look to conduct more studies remotely, some may consider creating their own DCT platform, known as a “homegrown” system, or licensing a DCT technology directly for the purposes of running their DCTs. Many technologies offer “Software as a Service” (SaaS), whereby the sponsor licenses online access to a technology, to use and deploy under its own processes. With SaaS, the sponsor may use the licensed technology to run its own studies internally or contract with service providers to manage and execute the studies, or a combination of both.