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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

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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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Pharmacokinetic–Pharmacodynamic Relationship: Dose to Pharmacological Effect01:28

Pharmacokinetic–Pharmacodynamic Relationship: Dose to Pharmacological Effect

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A drug’s dosage and pharmacokinetic properties determine how quickly it acts, how intense its effects are, and how long it lasts. Higher doses increase drug concentration at receptor sites, producing a hyperbolic curve when pharmacologic response is plotted against drug dose. Converting this scale to a log-linear format results in a sigmoidal curve, better representing dose–response relationships.For drugs following a one-compartment model, the pharmacologic response is directly...
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Pharmacokinetic–Pharmacodynamic Relationship: Duration of Dose-Effect Relationship01:14

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For drugs producing a quantal response, onset occurs when plasma concentration reaches a minimum effective level (Cmin). The drug's action duration depends on how long the plasma concentration remains above Cmin.Two primary factors influence this duration: dose size and the rate of drug removal from the action site. Both depend on the drug's redistribution to poorly perfused tissues and elimination processes. A larger dose promotes rapid onset and prolongs the effect's duration.Consider a...
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Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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In Silico Clinical Trials for Cardiovascular Disease
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dfpk: An R-package for Bayesian dose-finding designs using pharmacokinetics (PK) for phase I clinical trials.

A Toumazi1, E Comets2, C Alberti3

  • 1INSERM, UMRS 1138, Team 22, CRC, University Paris 5, University Paris 6, Paris, France.

Computer Methods and Programs in Biomedicine
|February 26, 2018
PubMed
Summary

This study introduces dfpk, an R package for Bayesian adaptive dose-finding studies that integrates pharmacokinetics (PK) and toxicity data. It facilitates designing early-phase clinical trials by estimating efficacy and suggesting optimal doses, improving drug development efficiency.

Keywords:
Dose-findingMaximum tolerated dosePharmacokineticsPhase I clinical trialsR package

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Area of Science:

  • Pharmacometrics
  • Clinical Trial Design
  • Statistical Software Development

Background:

  • Early-phase drug development relies on dose-finding and pharmacokinetics (PK) studies.
  • Combining PK and dose-finding in early human studies is complex and lacks readily available software solutions.
  • Previous work proposed Bayesian adaptive PK-based dose-finding designs for small populations.

Purpose of the Study:

  • To implement previously developed Bayesian adaptive pharmacokinetics-based dose-finding methods into a user-friendly R package named dfpk.
  • To provide a software tool that supports innovative dose-finding study designs integrating PK information.
  • To address the gap in available software for combined PK and dose-finding studies.

Main Methods:

  • Developed sequential Bayesian methods for dose-finding, utilizing Bayesian parameter estimation via the rstan package.
  • Integrated pharmacokinetics and toxicity data to recommend subsequent cohort doses, incorporating toxicity probability constraints.
  • Implemented stopping rules and used ggplot2 for visualizing toxicity and concentration data.

Main Results:

  • The dfpk package includes functions for estimating efficacy probability (nextDose) and suggesting next-cohort doses.
  • A function (nsim) is provided for trial simulations to aid in study design.
  • Example data simulation using a one-compartment PK model with linear absorption is included.

Conclusions:

  • The dfpk R package offers a user-friendly solution for designing advanced dose-finding studies.
  • It effectively integrates pharmacokinetic information into the dose-finding process.
  • The package is available on the CRAN repository, promoting wider adoption in drug development.