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Related Concept Videos

Clinical Trials01:16

Clinical Trials

7.0K
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

Clinical Trials: Overview

3.2K
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...
3.2K
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.6K
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...
4.6K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

162
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
162
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

363
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
363
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

658
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
658

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Updated: Aug 26, 2025

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
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The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

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Applying implementation frameworks to the clinical trial context.

Kristian D Stensland1,2, Anne E Sales3,4,5,6, Laura J Damschroder4

  • 1Dow Division of Health Services Research, Department of Urology, University of Michigan, NCRC Building 16, 100S-12, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA. kstens@med.umich.edu.

Implementation Science Communications
|October 10, 2022
PubMed
Summary
This summary is machine-generated.

Clinical trials, vital for medical progress, often struggle with low enrollment. Adapting implementation science frameworks offers a structured approach to improve clinical trial design and execution for better patient outcomes.

Keywords:
Clinical trialsConsolidated framework for implementation researchDeterminantsImplementation mappingImplementation outcomesImplementation research logic model

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Area of Science:

  • Implementation Science
  • Clinical Trial Methodology
  • Evidence-Based Practice

Background:

  • Clinical trials are crucial for scientific advancement and patient care but frequently face challenges with participant enrollment and achieving endpoints.
  • Existing methods for trial improvement lack reproducibility and impact, highlighting the need for a systematic framework.
  • Clinical trials can be viewed as evidence-based practices that suffer from implementation deficits.

Purpose of the Study:

  • To adapt existing implementation science frameworks for application within the clinical trial context.
  • To develop a model for identifying and selecting strategies to improve clinical trial implementation.
  • To explore the potential of implementation science to enhance trial design, execution, and evaluation.

Main Methods:

  • Adapted Proctor's Implementation Outcomes Framework and the Consolidated Framework for Implementation Research for clinical trials.
  • Linked these frameworks with ERIC-based strategies and developed an inferential process model.
  • Illustrated the model's application with a case study of a trial with low enrollment.

Main Results:

  • The adapted frameworks provide tools for contextual assessment, outcome measurement, and intervention selection in clinical trials.
  • The proposed model facilitates the identification and application of targeted improvement strategies.
  • Demonstrated a systematic approach to address poor enrollment and enhance trial conduct.

Conclusions:

  • Implementation science offers valuable frameworks for improving clinical trial conduct, assessment, and outcome measurement.
  • Applying implementation science to trials can advance the field by providing 'test cases' and a platform for intervention development.
  • This approach fosters a shared vocabulary and systematic methodology for clinical trial improvement.