RWD is useful for shortening new drug's approval period

Seoul National University research team cuts drug safety verification period by half with data

(From left) Professor Hyungki Lee & Ph.D student Yoomin Jeon

Opinion was raised that the use of RWD (Real Word Data) owned by The HIRA could accelerate and improve domestic drug development and new drug approval.

 

Prof.

 

Hyung-ki Lee and Ph.D student Yoo-min Jeon published their contributions in the HIRA Big Data Brief on the subject of 'The possibility of utilizing HIRA big data for efficient design, simulation, and pre-prediction of clinical trials.' The research team said that deriving meaningful RWE (Real Word Evidence) from high-quality RWD through appropriate analysis 1 method shortens the process of drug development as well as new drug approval, but the HIRA's RWD can be usefully used.

 

As a result of reproducing the CAROLINA clinical trial, which compared cardiovascular safety for diabetes treatments, Professor Patorno of the UK said that the group receiving 'Linagliptin' had more cardiovascular system than the group receiving 'Glimepiride'.

 

The risk was reduced by 9%.

 

While it took six weeks to analyze this data, it took a pharmaceutical company eight years to obtain the results of the Carolina clinical trial, and even including the four years it took to accumulate billing data, RWE is effectively used to reduce research costs and time.

 

It is the opinion of the research team that it can be done.

 

In particular, the HIRA's RWD has recently been emphasized in the epidemiological evaluation of the COVID-19 disease and monitoring the efficacy and safety of drugs.

 

The research team said, "The HIRA has released clinical data in a large-scale open source format for the first time in order to analyze COVID-19 test and medical bill data using a common data model (CDM)." It will be the basis for linking the hospital billing data with the HIRA, and by connecting the RWD possessed by the HIRA to the EMR that contains specific clinical information and test results of individual patients, the scope of domestic RWD use can be further expanded." However, in order to actually introduce the HIRA's RWD into domestic drug development and new drug approval, it suggested the need to approach short-term, mid-term, and long-term utilization plans.

 

First of all, it provides the basis for prescription and approval of over-licensed (off-label) drugs in therapeutic orphan groups such as children, the elderly, and pregnant women with RWD previously held as a short-term plan.

 

And they asked for help in the development process for rare disease treatments.

 

Lastly, the HIRA's RWD is used as a prototype of a national research cohort for the implementation of precision medicine, and a long-term use plan is needed to accelerate the process of developing innovative new drugs for new targets.

 

The research team said, "The HIRA has already revealed that it is a domestic leader in the field of RWD and RWE through the healthcare big date platform." And the research team then emphasized that "It is necessary to establish an action plan by driving the momentum of success in the initial stage, and to pursue it strategically after consulting external experts." Developed countries have been preparing guidelines and legislation to actively use RWE in regulatory decision-making for many years.

 

The US is focusing on securing RWD and RWE after the emphasis on developing patient-specific medicines through the '21st Century Remedial Act' in 2016 and the'Regulatory Science Strategy for 2025' in the UK this year.

 

As 'Data 3 Act' (Personal Information Protection Act, Credit Information Act, and Information and Communication Network Act) was implemented in Korea, the HIRA, the NHIS, the Korea Disease Control and Prevention Agency, and the National Cancer Center integrated health care big data.

 

It is now possible to use pseudonymized data.