Clinical Trial Descriptors Trends Insight

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Clinical Trial Descriptors Trends Insight Report Overview

Trial descriptors are specific trial designs that have been grouped within the clinical trials database on the pharmaceutical IC. The Clinical Trial Descriptors Trends Insight report provides a review of different clinical trial designs derived from GlobalData’s Clinical Trials Database. The report aims to provide analyses of these trials and assessment of trends in the data.

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Key Trials ·       Umbrella Clinical Trials

·       First-In-Human Clinical Trials (FIH)

·       Adaptive Design Clinical Trials

·       Pivotal/Registration and Post-Marketing Commitment Clinical Trials

·       Basket/Bucket Clinical Trials

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Clinical Trial Descriptors Trends Insight

Umbrella Clinical Trials: Umbrella trials are clinical trials with a master protocol design that is designed to evaluate multiple treatments or interventions for a specific disease or condition. These trials are mainly conducted in Phase II, which is the stage where the safety and effectiveness of a treatment are further evaluated. In Phase II, researchers aim to gather more data on the potential benefits and risks of different treatment options.

Number of Umbrella Clinical Trials, by Geography

Number of Umbrella Clinical Trials, by Geography

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First-In-Human Clinical Trials (FIH): FIH trials are the initial stage of human clinical trials for a new drug or treatment. These trials involve testing the investigational product on healthy human subjects or patients with the target disease or condition.

Adaptive Design Clinical Trials: Adaptive design studies allow modifications to the study design and/or statistical procedures based on accumulating data during the trial. Unlike traditional fixed design studies, adaptive design studies allow for flexibility and adjustments based on interim data analysis. The main goal of adaptive design studies is to improve the efficiency and effectiveness of clinical trials by making real-time adjustments in response to emerging data.

Pivotal/Registration and Post-Marketing Commitment Clinical Trials: A Pivotal/Registration trial, which is usually in Phase III, is a clinical trial that provides the evaluation of therapeutic safety and efficacy. It can be used, alone or with other pivotal or non-pivotal trials, to support regulatory approval. The Post Marketing Commitment trials, which usually are in Phase IV, help assess the safety, efficacy, and effectiveness of an already approved therapeutic. This can also aid real-world evidence studies in assessing efficacy data.

Basket/Bucket Clinical Trials: Basket/Bucket studies are clinical trials in which patients with different types of cancer or genetic changes are grouped based on a specific mutation or biomarker. In these trials, all patients receive the same treatment that targets the specific mutation or biomarker found in their indication. Basket studies are often conducted in Phase II because this phase allows researchers to gather preliminary efficacy data and evaluate the drug’s effectiveness in treating specific targeted diseases.

Scope

  • This report provides an overview of various clinical trial descriptors captured in the GlobalData Pharma Intelligence Center until September 3, 2023.
  • This report provides a review of different clinical trial designs derived from the GlobalData’s Clinical Trials Database. This report aims to provide analyses of these trials and assessment of trends in the data.

Reasons to Buy

  • Understand the global clinical trial landscape for different trial descriptors.
  • Identify key analysis of main features within several different trial descriptors.

Table of Contents

Tables and Figures

Executive Summary

Introduction

Examining Trial Descriptors

Key Findings

Appendix

Table

Table 1: Count of Clinical Trial Designs

Figures

Figure 1 & 2: Number of FIH clinical trials, by phase and trial start year

Figure 3: Number of FIH clinical trials, by therapy area

Figure 4: Number of FIH clinical trials, by geography

Figure 5 & 6: Number of FIH clinical trials, by sponsor

Figure 7 & 8: Number of adaptive design clinical trials, by phase and trial start year

Figure 9: Number of adaptive design clinical trials, by therapy area

Figure 10: Number of adaptive design clinical trials, by geography

Figure 11 & 12: Number of adaptive design clinical trials, by sponsor

Figure 13 & 14: Number of pivotal/registration & post marketing commitment clinical trials, by year and sponsor type

Figure 15 & 16: Number of pivotal/registration & post marketing commitment clinical trials, by therapy area

Figure 17: Number of pivotal/registration clinical trials, by geography

Figure 18: Number of approved drugs with post marketing commitments clinical trials

Figure 19 & 20: Number of pivotal/registration clinical trials, by sponsor

Figure 21 & 22: Number of post marketing commitment clinical trials, by sponsor

Figure 23 & 24: Number of basket/bucket clinical trials, by phase and trial start year

Figure 25 & 26: Number of basket/bucket clinical trials, by therapy area and indication

Figure 27: Number of basket/bucket clinical trials, by geography

Figure 28 & 29: Number of basket/bucket clinical trials, by sponsor

Figure 30 & 31: Number of umbrella clinical trials, by phase and trial start year

Figure 32 & 33: Number of umbrella clinical trials, by therapy area and indication

Figure 35 & 36: Number of umbrella clinical trials, by sponsor

Frequently asked questions

  • What are umbrella trials?

    Umbrella trials are clinical trials with a master protocol design that is designed to evaluate multiple treatments or interventions for a specific disease or condition.

  • What are FIH trials?

    FIH trials are the initial stage of human clinical trials for a new drug or treatment. These trials involve testing the investigational product on healthy human subjects or patients with the target disease or condition.

  • What are basket/bucket trials?

    Basket/bucket studies are clinical trials in which patients with different types of cancer or genetic changes are grouped based on a specific mutation or biomarker.

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