• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• Journal of Society of Preventive Korean Medicine
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• v.17 no.3
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• pp.143-153
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• 2013

Objective : This study was done to define the treatment protocol of Traditional Korean Medicine for persistent allergic rhinitis, which might be necessary for conducting PRCT study. Methods : Data were collected by questionnaire from Korean Medicine doctors participated in the Conference of The Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology Society in October 2012. We investigated their treatment procedures for persistent allergic rhinitis in ordinary clinical settings. Their treatment patterns including annual treatment period, frequencies and treatment times were also investigated. Finally, we combined the national insurance covered or out-of-pocket treatments as treatment packages according to the response rates of each contents, and displayed them as treatment protocols for PRCT study. Results : 50 Korean medicine doctors described the informed consent and questionnaire. Response rates of each treatment procedure were listed in Table 2 to Table 5. Treatment periods, frequencies and treatment time of each visit were listed in Table 6. Finally, treatment packages which would be defined for PRCT were listed in Table 7 as treatment package 1(response rates were over 50%), package 2(response rates were over 25%), package 3(response rates were over10%). Conclusion : These results provide the rational background and preliminary sources of defining treatment packages for developing PRCT protocols.