'Korea should introduce decentralized clinical trials for post-pandemic drug development’

The Korean government should improve the regulatory regime to introduce decentralized clinical trials (DCT) to cope with the new environment for developing drugs, as seen during the Covid-19 pandemic, foreign experts said on Wednesday.

Medidata’s co-founder, Glen de Vries (left), and Marcello Damiani, chief digital and operational officer at Moderna, shared their experiences and insights concerning decentralized clinical trials in an online meeting organized by Medidata on Wednesday.

Medidata, a company leading the digital transformation of life sciences, organized an online conference.

The meeting was designed to discuss the need to introduce DCT when clinical trials are shifting from institution-centered studies to remote research by adopting electronic consent forms, telemedicine, and drug delivery in the post-pandemic world, a company official said.

DCT applies to patient recruitment to diagnosis using mobile or wearable devices, clinical data collection, remote monitoring, and prescription. The concept emerged as a global trend with the rising need of companies to see rapid clinical results due to the Covid-19 pandemic. The U.S., Japan, and China allowed companies to use DCT platforms, but the regulations for the studies are still rigid.

Marcello Damiani, the chief digital and operational officer of Moderna, shared how his company used DCT in developing its Covid-19 vaccine.

According to Damiani, Moderna recruited 30,000 participants to conduct clinical trials in 12 weeks to develop an mRNA vaccine under the unfavorable circumstances of Covid-19. The company succeeded in shortening the development period from 10 years to less than a year by using Medidata's DCT platforms, including Rave EDC, eCOA, and Detect for the studies.

Damiani said that the company made decisions based on real-time data and reflected external datasets to identify the most at-risk patient groups and countries in clinical trials, believing that the data management systems and integration have led to the success of clinical trials.

"We have 37 programs now, and 22 are clinical trials. Digital is becoming a key in analyzing and capturing data to make the best out of the clinical trials," Damiani said. "Clinical data is sometimes personalized when it comes to tailored cancer vaccines which we are working on, and the data environment needs to be maybe 10 times more intensive than the one that we have today."

Damiani also pointed out that all the external data collected from the healthcare system, hospitals, or any other health environment are a key element in the studies, saying, "The collected data could drastically help improve what companies can do in clinical trials to achieve drugs to help cure any disease," he said.

Some sophisticated technologies help companies curate the data and get insight from the data where the human mind could not achieve, Damiani said.

"We believe DCT is a very powerful tool, and this is where we are trying to go to help build the future of drugs and medicines and deliver them to the world."

Scott Gottlieb, former chief of the U.S. Food and Drug Administration, pointed out that FDA made flexible moves to adopt new methods promoting clinical trial systems based on data, such as electronic medical records (EMR), different from the existing ways of evaluating studies.

"This is because the FDA has speeded up the introduction of new regulations in various types of data collection methods, drug delivery, and self-injection after the pandemic," Gottlieb said.

He explained that there is a risk of criticism for the fast track designation as the nation has recently raised controversies regarding the approval of Alzheimer's treatments.

"The frameworks for related policies are also being considered to improve the quality of integrated data," Gottlieb said. "As electronic data collection has become the mainstream with more active communications from patients, we require a more rigorous verification of the data and a real-time investigation."