2023-01-06
Taiwan CDE Consultation Preparation and Application for Phase 2 Clinical Trial Consultation
EffPha specialized in clinical trial design, particularly for early phase clinical trials in oncology. We offer greater flexibility for your drug development projects.
The Challenge
A global pharmaceutical company approached EffPha for assistance in preparing and submitting a consultation request to the Center for Drug Evaluation (CDE) in Taiwan.
The client intended to initiate a Phase 2a proof-of-concept (POC) study in Taiwan and would like to obtain the Agency’s feedback on the nonclinical data, clinical data and the design of the proposed Phase 2a study.
The primary challenge was to obtain the CDE's agreement on the new indication, dose, and endpoints proposed for the Phase 2a study based on the available data.
The Solution
The EffPha team analyzed the non-clinical and clinical study reports and determined that the proposed dose was safe for Asian population based on several Phase 1 or Phase 1/2 studies done in cancer patients in another Asian country.
In close collaboration with the client, the team formulated relevant questions and prepared a detailed briefing package for the CDE consultation. We made sure that the questions were clear and focused. Moreover, we gathered and integrated the investigators’ feedback into the Phase 2a study protocol.
The EffPha team also met with CDE informally following the submission of the consultation request to clarify the meeting objectives. After receiving CDE’s written responses, we facilitated further discussion between the client and the CDE to ascertain the recommendations. We also revised the study protocol according to the CDE’s recommendations.
Results
Acting as the client’s regulatory representative in Taiwan, the EffPha team prepared and submitted the IND dossier to the Taiwan Food and Drug Administration (TFDA). The study was approved at the end of the review period and EffPha is overseeing and managing this Phase 2a study across 6 study centers throughout different regions in Taiwan.
The Challenge
A global pharmaceutical company approached EffPha for assistance in preparing and submitting a consultation request to the Center for Drug Evaluation (CDE) in Taiwan.
The client intended to initiate a Phase 2a proof-of-concept (POC) study in Taiwan and would like to obtain the Agency’s feedback on the nonclinical data, clinical data and the design of the proposed Phase 2a study.
The primary challenge was to obtain the CDE's agreement on the new indication, dose, and endpoints proposed for the Phase 2a study based on the available data.
The Solution
The EffPha team analyzed the non-clinical and clinical study reports and determined that the proposed dose was safe for Asian population based on several Phase 1 or Phase 1/2 studies done in cancer patients in another Asian country.
In close collaboration with the client, the team formulated relevant questions and prepared a detailed briefing package for the CDE consultation. We made sure that the questions were clear and focused. Moreover, we gathered and integrated the investigators’ feedback into the Phase 2a study protocol.
The EffPha team also met with CDE informally following the submission of the consultation request to clarify the meeting objectives. After receiving CDE’s written responses, we facilitated further discussion between the client and the CDE to ascertain the recommendations. We also revised the study protocol according to the CDE’s recommendations.
Results
Acting as the client’s regulatory representative in Taiwan, the EffPha team prepared and submitted the IND dossier to the Taiwan Food and Drug Administration (TFDA). The study was approved at the end of the review period and EffPha is overseeing and managing this Phase 2a study across 6 study centers throughout different regions in Taiwan.