“Providing as much clinical information for patients”

MFDS Director Kim Jeong-mi “Securing competitiveness by tightening safety control”

Need to shift negative bias on clinical trial, trying to enhance review system for early stage trials

Director Kim Jeong-mi of Clinical Trial Management Division

Since the end of last October, the Korean Ministry of Food and Drug Safety (MFDS) has expanded scope of information on approved investigation new drug’s (IND) protocol uploaded on its website.

 

Previously, only the names of clinical trial, sponsoring client, IND, targeting disease and clinical trial institute were publicly disclosed, but now more information, including comparison drug, contact information of the institute, subject selection and exemption standards are also uploaded online.

 

Anyone can now check a company’s R&D progress in detail on the website, and patients can search information and actively participate in a clinical trial by contacting the clinical institute directly.

 

At a press conference held on Dec.

 

3, Director Kim Jeong-mi of Clinical Trial Management Division at MFDS explained, “Although clinical trial information has been disclosed since 2007, we’ve been thinking that we are not meeting the patients’ expectation.

 

We recognized the need to publicly provide similar level of information as other countries, so we formed a consultative body for clinical trial system development to specify expansion of the provided information.” “Our principle is to disclose as much information as the U.S.

 

or EU.

 

But the update has been slow as double-checking accurate information is taking more time than we expected,” Director Kim added.

 

Expanding provided scope of clinical protocol information is expected to support patient’s right to know and their active participation in clinical trials.

 

Revealing contact information of the healthcare institute was to meet the existing demands of patients seeking opportunities to participate.

 

“These days, patients have gotten sophisticated so much to actively look for related information and to get highly knowledgeable in particular medicines.

 

Naturally, they are curious about contact information of clinical institute and doctors in charge.

 

Some are even eager to transfer the hospitals to participate in clinical studies”, Director Kim elaborated.

 

Disclosed clinical protocol information has been expanded partially, but the website still lacks in system stability and promotion.

 

Particularly because MFDS’ Drug Information System website (www.nedrug.mfds.go.kr) provides a vast amount of information on drugs, searching for IND approval status on the website takes a long time.

 

Moreover, many people still do not realize the website provides IND information.

 

The director said, “We still need to contemplate on how to provide the information with easier access.

 

Also we are considering on making information search easier for IND developers and researchers.” In August, MFDS announced the Five-year Master Plan on Developing Clinical Trial System.

 

The five-year plan aims to strengthen safety control over clinical trials and enhancing international competitiveness.

 

Director Kim commented, “We have had a lot to ponder as transnational clinical trials have been stagnating recently and we want to create an advanced clinical environment and protocol review system in Korea attractive enough for Korean companies to develop global IND.

 

The five-year plan has details of strengthening safety management and international competitiveness, communicating better of clinical trials and shifting public’s bias.” One of the highlights of the plan was making drug safety update report (DSUR) mandatory.

 

The director explained, “Unlike late-phase clinical trials, earlier-stage trials have more prevalent risk of safety issue and adverse reaction.

 

And to promote the earlier stages of trials, the ministry plans to tighten evaluation on trial sponsor and safety control on trial conductor.

 

DSUR has been filed by multinational pharmaceutical companies, but we are also asking Korean companies to file them with the amendments.” Review on early phase clinical trials would be strengthened as well.

 

By forming Innovative Early-phase Clinical Trial Review Team, MFDS plans to conduct overall review not only for INDs, but also on pharmacology test, quality, and statistics.

 

“Without removing negative bias on clinical trials, Korea would struggle to acquire clinical competitiveness.

 

We are planning to extend communication channel and to raise better awareness of clinical trials by working closely with Korea National Enterprise for Clinical Trials (KONECT) and consultative body for clinical protocol review,” Director Kim said.

 

Nevertheless, the director stressed, “In other countries, clinical trial participation is considered as a ‘volunteer service’ with a side of treatment opportunity.

 

But in Korea, clinical trials are regarded negatively rather than necessary.

 

When the majority of the public can agree clinical trial is essential to the society, the need of new drug development and industrial benefit of drug development could be emphasized.”