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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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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.
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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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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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A maturity model for Clinical Trials Management Ecosystem.

Shruti Sehgal1, E Chris Pua2, Svetlana Rojevsky3

  • 1Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

Journal of Clinical and Translational Science
|March 7, 2025
PubMed
Summary

A new Clinical Trials Management Ecosystem (CTME) maturity model (MM) was developed to assess institutional capabilities. The model identified study and investigational product management as mature, while reporting analytics and dashboards require improvement.

Keywords:
Clinical Trials Management Ecosystemclinical and translational researchclinical trialsinformaticsmaturity models

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Area of Science:

  • Clinical research informatics
  • Maturity modeling
  • Healthcare management

Background:

  • Clinical trial management is complex, requiring integration of human resources, technology, compliance, and operations.
  • Assessing and improving Clinical Trials Management Ecosystem (CTME) capabilities is crucial for research organizations.

Purpose of the Study:

  • To develop a multi-axial maturity model (MM) for evaluating Clinical Trials Management Ecosystem (CTME) capabilities.
  • To provide a framework for institutions to identify best practices and areas for growth in clinical trial management.

Main Methods:

  • A working group of research informaticists developed the CTME MM, defining 11 axes and five maturity levels.
  • A REDCap survey was created based on the model and administered to assess institutional maturity.

Main Results:

  • The CTME MM was developed with 11 axes, including study management, regulatory affairs, financial management, and data analytics.
  • Self-assessments across 22 institutions indicated high maturity in study and investigational product management.
  • Reporting analytics and dashboard capabilities were identified as the least mature areas.

Conclusions:

  • The CTME MM offers a structured framework for research organizations to evaluate their clinical trial management maturity.
  • The model aids in identifying specific areas for improvement and strategic development within CTME capabilities.