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Related Concept Videos

Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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A Bayesian phase I/II platform design for co-developing drug combination therapies for multiple indications.

Rongji Mu1, Jin Xu2, Rui Sammi Tang3

  • 1Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Statistics in Medicine
|November 3, 2021
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Summary

This study introduces a Bayesian platform design for efficiently co-developing combination cancer therapies. The approach accelerates the identification of optimal biological doses by borrowing information across multiple indications.

Keywords:
Bayesian adaptive designimmunotherapyoptimal biological doseplatform trialrisk-benefit tradeoff

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Area of Science:

  • Oncology
  • Clinical Trial Design
  • Biostatistics

Background:

  • Combination therapies involving targeted or immunotherapy agents are increasingly used in cancer treatment.
  • Developing these combination therapies requires efficient and flexible clinical trial designs.

Purpose of the Study:

  • To propose a master-protocol-based, Bayesian phase I/II platform design for co-developing combination therapies (BPCC) across multiple cancer indications.
  • To enhance efficiency in dose-finding and decision-making for combination therapies.

Main Methods:

  • Utilizing a single master protocol to evaluate combination drugs concurrently or sequentially across indications.
  • Employing Bayesian hierarchical models to jointly model dose-toxicity and dose-efficacy relationships, enabling information sharing across indications.
  • Incorporating a utility function to quantify risk-benefit tradeoffs, especially for agents with non-monotonic dose-efficacy profiles.

Main Results:

  • The BPCC design allows for efficient indication-specific decision-making by borrowing strength across indications.
  • Interim analyses update toxicity, efficacy, and utility models, informing dose escalation/de-escalation and optimal dose identification.
  • Simulation studies demonstrate desirable operating characteristics and efficiency gains.

Conclusions:

  • The proposed Bayesian platform design (BPCC) offers an efficient strategy for accelerating the co-development of novel combination cancer therapies.
  • This approach facilitates robust decision-making by integrating dose-toxicity and dose-efficacy data across multiple indications.