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Generalized strategy for early clinical development – integrated scientific and operation solutions
2021-05-25Return>>
At 2021 DIA China Annual Meeting, Dr. Jun Shi systematically elaborated eight main strategies for accelerating clinical development in the early clinical development stage, and proposed that under the need for ensuring quality, improving the efficiency of clinical development, and accelerating the process of globalization are the key to the development of innovative drugs. The acceleration space is mainly in the early clinical development, which can lay a solid foundation for later confirmatory clinical research.


The key strategies are as follows:
First, find out the difference (resolution) between new and old molecules at the early clinical stage, and predict the possibility of new drugs beating old drugs in clinical Phase 3 H2H comparison (mainly as a differentiated development strategy for me-better compound);

Second, based on the technical support of modeling and simulation, the dosage and administration schemes should be optimized. Starting from the modeling and Simulation of translational PK / PD, the first "learn confirm cycle" was constructed at the interface of preclinical to clinical stage, which was continuously enriched and updated by real-time modeling and simulation in the clinical stage;

Third, the application of biomarkers should be considered for patient stratification (enrichment design and precision medicine strategy), dose optimization or efficacy prediction;

Fourth, in the early stage of clinical development, the strategy of combination treatment should be explored to increase the success rate of drug development and reduce toxicity for which single molecule is inadequate;

Fifth, adoption of novel clinical trial designs (Bayesian adaptation, enrichment, umbrella, basket and platform design) can improve the efficiency of clinical development and reduce the cost of development;

Sixth, the choice of indications can improve the regulatory approval process. Thus rapid market entry requires careful assessment; In addition, the indication expansion strategy can be simplified for fast followers relative to the complicated cycle of "first in class" drugs, and even adopt parallel design in phase 3 for several different indications;

Seventh, an one-stop service of hospital, CRO and SMO should be built to achieve excellent clinical operation and execution;

Eighth, scientific and systematic assessment of ethnic sensitivity should be carried out to formulate global development strategies in the early clinical stage.

As a new generation of global clinical CRO, dMed-Clinipace, provides customized service or one-stop service, paying equal attention to strategy and implementation, scientific driving and focusing on quality. We advocate an one team approach, making it an "extension arm" and "empowering hand" for our clients. In particular, we have an international professional team for early clinical development and registration, providing services to all kinds of customers, helping innovative companies adapt to the regulatory environment in China and major regions of the world, integrating resources, and laying a solid foundation for confirmatory clinical trials.

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