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P223: The Benefit of Bridging Study Strategy Consultation in Taiwan CDE

Poster Presenter

Chiao Fu Lai

Project Manager
TFDA/Center for Drug Evaluation
Taiwan

Objectives

Taiwan Center for Drug Evaluation (CDE) has provided Bridging Study Strategy Consultation service since 2018. The purpose of this analysis is to follow up the regulatory status of the cases which received Bridging Study Strategy Consultation and evaluate the benefit of consultation services.

Method

All Bridging Study Strategy Consultation cases between 2018 and 2022 were collected and the regulatory status of clinical trial submission (IND), bridging study evaluation (BSE) and new drug application (NDA) were followed up by using CDE E-management Database.

Results

Between 2018 and 2022, there were a total of 21 Bridging Study Strategy Consultation cases. These cases can be divided into 3 categories depending on the drug development status: 1.CCDP (complete clinical data package) is finalized, before for BSE submission 2.CCDP is not finalized, for example, a phase III study design (including the number of Taiwanese) is under discussion 3.A bridging study(BS) non-waiver is issued by Taiwan FDA(TFDA) There were 10 cases in the first category. CDE helped the applicants perform adequate analysis to evaluate whether ethnic difference existed between Taiwanese and foreign population during consultation. The analysis included pharmacokinetics, pharmacodynamics, clinical efficacy and safety. Seven of these 10 cases took CDE’s advice to prepare their bridging data package, 5 cases submitted BSE to TFDA and received BS waiver smoothly, later 3 of them got NDA approval by TFDA. In the other 2 cases, issue of ethnic difference was reviewed during NDA, no further query about bridging was requested and approval were granted by TFDA. Four of the 5 BS waiver cases (80%) didn’t receive information request letter from TFDA and saved 40% of review time. Between 2018 and 2022, for those BSE cases without prior Bridging Study Strategy consultation, only 8% didn’t receive information request letter from TFDA. There were 8 cases in the second category. CDE provided suggestions on number of Taiwanese, endpoint chosen, subgroup analysis in pivotal studies during Consultation. Four of these 8 cases followed CDE’s suggestions to modify the protocol, set number of enrolled Taiwanese. These clinical trials were approved by TFDA and are currently ongoing. There were 3 cases in the third category. CDE explained the deficiency of bridging data package and assisted the applicants in designing bridging study during consultation. One of these cases took CDE’s advice to adjust the protocol, this bridging study was approved by TFDA and is currently ongoing.

Conclusion

ICH E5 and E17 were implemented by TFDA in 2009 and 2021, respectively. If Taiwanese(Asian) could be enrolled early in the drug develop stage, that would be very helpful in understanding the impact of intrinsic and extrinsic ethnic factors and provide valuable information during BSE to understand whether treatment effect is similar between Taiwanese and overall population. In Bridging Study Strategy Consultation, CDE can help the applicants to design pharmacokinetic study in order to understand whether intrinsic ethnic difference exists, and to evaluate the pharmacokinetic results between Taiwanese (Asian) and Western population. CDE can provide suggestions on the number of Taiwanese, subgroup analysis in clinical trials in order to understand whether ethnic difference exists. CDE can also help to prepare adequate bridging data package which could facilitate bridging study evaluation process. BSE cases with prior Bridging Study Strategy consultation had apparently lower chance to receive information request letter from TFDA compared to those BSE cases without prior consultation (20% vs 92%). The analysis of the 21 Bridging Study Strategy consultation cases showed that early consultation can streamline the following regulatory process, including IND, BSE and NDA.