Decentralized Clinical Trials: What You Need to Know

Published on April 14, 2023
Written by: Dora Harding
Decentralized Clinical Trials: What You Need to Know

Decentralized Clinical Trials FDA

Clinical research is hugely significant in drug development. Since the covid-19 pandemic, decentralized clinical trials FDA have been a huge step forward for research in a public health emergency.

Clinical studies have been around for years. How else would we have safe drugs and treatments?

But with a pandemic sweeping the country, it needed to be easier for patients to participate in these. This was without the need to travel or be in the same room as anyone else.

Clinical trials are rapidly increasing, so here is some information about them.

Benefits Of Decentralized Clinical Trials For Patients

As mentioned previously, the main benefit of these trials is that patients no longer need to travel across the country to a trial site to be able to participate in a decentralized clinical trial.

Registered studies can take place in the United States and the results database can be held elsewhere which is very useful. This also implies that you can improve data diversity if you get human subjects from multiple locations.

Trial design can be made to suit an individual to an extent to work around their needs. This means getting patients to sign up for studies will be easier and keep them interested/involved as the trial progresses. The less you have to say “put patients out” of their day-to-day lives, the better.

Benefits Of Decentralized Clinical Trials For Sponsors

Since the covid-19 pandemic, clinical trials have become even more important. With these decentralized trials, people don’t have to be in the same room as each other, resulting in less risk of virus transmission.

It also means that patients can take part in these clinical trials during their normal, day-to-day activities, potentially reducing the risk of “white coat syndrome”. So this will result in more reliable results for sponsors and better clinical practice overall.

Partial decentralized clinical trials can also occur if human subjects need drug administration as part of their trial. So this means that people can do most of their trials at home, which is even more helpful in the long run.

The U.S. Food and Drug Administration is (and has) changed its guidelines and wants more diversity in these trials. More diversity means safer studies and more research on minority groups. FDA guidance and FDA regulations help sponsors keep their studies safe.

Use of technology in decentralized clinical trials

Medical devices can be used in the home, rather than in a clinical setting to collect data about patients. Wearables can monitor patients from their living spaces.

Digital health technologies allow remote monitoring of trial participants in the US and beyond. But alongside this, informed consent needs to be used so that patients know what’s happening with their data collection beyond their day-to-day lives.