Bringing it home: The next generation of clinical trials
Presented by: Craig Lipset, Decentralized Trials & Research Alliance (DTRA)
Decentralized trials (DCTs) are a new form of trial in which the patient is placed at the center instead of the site
DCTs are defined by the presence of technology or processes that enable patient visits outside of a traditional research site
- Technology to include the use of digital tools to collect digital endpoint data and conduct virtual patient visits
- Personnel visits, local and central laboratories, access to products, and potentially a centralized principal investigator
The work of the DTRA was accelerated by the COVID-19 pandemic; however, the DCT concept existed long before 2020
- Pre-pandemic: tools were in development to improve recruitment, patient retention, patient access to clinical trials, and adherence
- Peri-pandemic: DCTs were implemented to provide trial continuity, facilitate data collection, and ensure patients had safe access to trial products and monitoring
- Post-pandemic: DCTs will likely remain because access issues will endure
It is likely that this shift – from traditional research site–based clinical trials to a model in which at least part of the data collection occurs within the patient’s home or in the office of a local primary care physician – will be a lasting change. With this knowledge, the DTRA is focused on developing recommendations to overcome four challenges:
- Definitions
- Best practices
- Gathering evidence
- Removing barriers
How can medical communications aid the DTRA initiative?
- Medical communications can raise awareness of DCT research efforts
- Publications can define more consistent and clear terms for this type of clinical research and normalize DCT, making the processes more familiar