Dr Urvisha Ram

Various concepts can describe decentralized trials as decentralized means to distribute administrative or operational functions. In clinical trials, decentralized clinical trials can be referred to by multiple ideas, such as user processes and technologies differing from the traditional method of clinical trials. The goal is to make clinical trial activities easier for patients and researchers.

The decentralized trial does not mean performing the trials without any human touch or in the absence of any healthcare personnel. Instead, DCT is looking at areas and solutions where technologies and other concepts can be identified to take a hybrid approach to clinical trial activities, providing an alternative to current clinical trial designs.

We have seen numerous challenges faced by researchers and even participants; a decentralized clinical trial represents an opportunity to rethink the traditional method of clinical trial activities and how all those challenges can be overcome. DCT can be considered the essence of a patient-centric approach to clinical trial design.

At the time of the pandemic, all that changed now, and we are anticipating a new path for the future of clinical trials. To Continue the progress, the team need to encouragingly support decentralization as they need to be sure they can implement it.

When it comes to trial decentralization, additional challenges or barriers may be faced:

Some of the critical challenges associated with decentralized trials are: 

Coping with digital innovation integration may be smoother than I thought. Increased complexity can add complication to trial completion. When systems are designed as per trial needs, the growth in data sources can be improved, leading to errors and extended timelines. 

In some cases, there comes a situation where participant comfort with the digital system still needs to be achieved. Having Access to broadband is also a significant challenge.

Planning the decentralized clinical trials with regulatory guidelines in place is more of a challenge, requiring careful detailing and planning and all the team members and departments at the same pace.

Benefits of Decentralized Clinical Trials:

It will accelerate patient recruitment, making it easier and less burdensome for CRO/Sponsor. Technological integration helps in designing the trial in such a way that it reduces the burden for participants. Once the system and data are in place as per trial needs will help in capturing the real-time data to be integrated with the EDC system.

Automated systems with notifications and reminders to participants help to increase compliance, which helps to complete the study quickly.

Using a hybrid model, virtualizing the site activities allows the team to serve more patients across multiple regions.

Conclusions:

Decentralized Clinical Trials are not only one solution for some trial activities; an approach to a hybrid model will be necessary, and the traditional site-centric model needs to evolve. Decentralized clinical trials will shape the trial process and its policies. With all those challenges, there comes an opportunity which is certainly needed. A successful plan and its execution can transit traditional clinical trials into decentralized clinical trials.

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