Since the COVID-19 pandemic, decentralized clinical trials (DCTs) are becoming a tendency as technology, infrastructure, and knowledge have developed to support their use. DCTs can be defined as trials executed through telemedicine, healthcare providers and/or mobile technologies.
They can recruit participants from anywhere, potentially resulting in accelerated enrollment and more diverse participants. Moreover, measurements can be more frequent or even continuous because they are not restricted by scheduled site visits. Examples of decentralized trial elements include:
- recruitment via social media,
- shipping study drugs directly to participants,
- data collection through digital platforms,
- and telemedicine visits to integrate trial participation into participants’ daily lives by reducing the need to physically attend on- site visits.
In a PPD decentralized clinical trials survey report (2021) 63% of the companies interviewed were actively using digital and decentralized trial options. According to the therapeutic focus in the research pipeline, oncological, rare diseases, and immunology along with rheumatology where areas were hybrid designs are gaining an interesting growth with 57%, 61% and 44% respectively of trials under this design.
Despite the potential benefits of DCTs, adoption has been slow and variable. Some limitations may be related to an immature digital infrastructure, limited experience with the approach and the perception of regulatory barriers with implementing and using data from DCTs.
What has been your experience with decentralized clinical studies? What limitations, in addition to those mentioned above, might be encountered?
