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Regulator allows easier access to clinical trial participation, inquiry

Lee Hye-seon  Published 2019.10.24  15:36  Updated 2019.10.24 17:45

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The regulator said it would allow patients and guardians to check with information about clinical trials for participation quickly.

The Ministry of Food and Drug Safety said it would open clinical trial information on the website at nedrug.mfds.go.kr on Saturday. Patients or guardians can find clinical trials information regarding diseases, hospital contacts, participation criteria, and progress, it added.

To date, the government has disclosed only simple information such as the title of the clinical study and medical sites. From now on, the website will offer detailed information such as contacts for hospitals where studies take place, the criteria for recruiting patients, and trial progress.

The ministry will release detailed information from clinical trials approved, from Saturday, and will expand the provision of information on studies approved before the opening of the trial information.

The provision of clinical trial information is part of the implementation of the “clinical trial information registration and disclosure system,” under the comprehensive five-year plan to advance clinical trials announced in August.

The food and drug ministry ran a pilot system on the website from Sept. 30 to Oct. 25 and improved functions to make it easier for people to check information. Before the pilot run, the ministry also distributed a guideline for registering and opening clinical trial information in September.

“The information disclosure will help not only patients wanting to participate in trials but researchers and companies to advance their research and development. We will continue to provide useful information to support socially vulnerable people such as patients with rare and intractable diseases,” the ministry said.

lhs@docdocdoc.co.kr

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