2023-03-03
Taiwan CDE Consultation Preparation and Application for Phase 3 Clinical Trial Consultation
EffPha’s team of scientific and statistical experts are experienced in clinical study design. We always start with the end in mind and strive to deliver high-quality solutions that balance scientific rigor and pragmatism.
The Challenge
A prominent pharmaceutical company enlisted EffPha’s technical expertise in the design of a pivotal trial. The client’s objective is to develop a new indication for their generic drug in Taiwan. They believed the data from their Phase 2a clinical study, along with the published findings from animal studies, provided ample support to pursue the second indication.
The goal is to seek feedback and gain preliminary agreement on critical aspects of the proposed development program from the Center for Drug Evaluation (CDE) through their consultation service.
The Solution
After analyzing the data from the Phase 2a study and conducting a thorough review of relevant literature, the EffPha team engaged in strategic discussion with the client to determine the optimal approach, either a single Phase 3 pivotal study or a phased approach involving a Phase 2 study followed by a Phase 3 study.
Following careful consideration, the client decided to proceed with a single Phase 3 study. They then sought EffPha’s assistance in the development of the study protocol and the preparation of the briefing package for CDE consultation.
Our Statistical and Clinical Directors actively contributed to the process, providing valuable insights on crucial aspects such as endpoint selection, statistical analysis and, importantly, topics to be discussed with the Agency. The team then formulated clearly worded questions that are scientifically sound and aligned with regulatory requirements. Moreover, our scientists played a vital role in collecting and incorporating feedback from the investigators, ensuring their inputs were taken into account during the development of the study protocol.
All these preparations proved beneficial in securing CDE’s agreement on the proposed development program. The Agency also provided specific recommendations for the Phase 3 pivotal study in their written responses. These recommendations serve as valuable guidance for further optimizing the study design.
Results
As a result of these collaborative efforts, the development timeline was successfully shortened. The initial IND for the Phase 3 pivotal study was submitted without any delay. The submission underwent a smooth review process, receiving approval from the Taiwan Food and Drug Administration (TFDA) with only minor revisions required. The study is ongoing at 13 clinical sites in Taiwan.
The Challenge
A prominent pharmaceutical company enlisted EffPha’s technical expertise in the design of a pivotal trial. The client’s objective is to develop a new indication for their generic drug in Taiwan. They believed the data from their Phase 2a clinical study, along with the published findings from animal studies, provided ample support to pursue the second indication.
The goal is to seek feedback and gain preliminary agreement on critical aspects of the proposed development program from the Center for Drug Evaluation (CDE) through their consultation service.
The Solution
After analyzing the data from the Phase 2a study and conducting a thorough review of relevant literature, the EffPha team engaged in strategic discussion with the client to determine the optimal approach, either a single Phase 3 pivotal study or a phased approach involving a Phase 2 study followed by a Phase 3 study.
Following careful consideration, the client decided to proceed with a single Phase 3 study. They then sought EffPha’s assistance in the development of the study protocol and the preparation of the briefing package for CDE consultation.
Our Statistical and Clinical Directors actively contributed to the process, providing valuable insights on crucial aspects such as endpoint selection, statistical analysis and, importantly, topics to be discussed with the Agency. The team then formulated clearly worded questions that are scientifically sound and aligned with regulatory requirements. Moreover, our scientists played a vital role in collecting and incorporating feedback from the investigators, ensuring their inputs were taken into account during the development of the study protocol.
All these preparations proved beneficial in securing CDE’s agreement on the proposed development program. The Agency also provided specific recommendations for the Phase 3 pivotal study in their written responses. These recommendations serve as valuable guidance for further optimizing the study design.
Results
As a result of these collaborative efforts, the development timeline was successfully shortened. The initial IND for the Phase 3 pivotal study was submitted without any delay. The submission underwent a smooth review process, receiving approval from the Taiwan Food and Drug Administration (TFDA) with only minor revisions required. The study is ongoing at 13 clinical sites in Taiwan.