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Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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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.
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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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Correction to: Computer-Aided Colonoscopy Alert Fatigue and Its Effect on Adenoma Detection.

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Related Experiment Video

Updated: Jan 17, 2026

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Of Endpoints and Equipoise: Reforming Clinical Trials in Colorectal Polyp Resection.

Zachary L Smith1, Nauzer Forbes2, Srivats Madhavan3

  • 1Division of Gastroenterology and Hepatology, Wisconsin Institute for Research in Endoscopy (WIRE), Medical College of Wisconsin, 8701 Watertown Plank Rd, Hub 6th Floor, Milwaukee, 53226, WI, USA. zsmith@mcw.edu.

Current Gastroenterology Reports
|September 18, 2025
PubMed
Summary

Endoscopic mucosal resection (EMR) trial designs need updating. Innovations in outcomes and statistics can improve relevance and generalizability for colorectal polyp resection research.

Keywords:
Adenoma recurrenceClinical trial endpointsColorectal neoplasiaEndoscopic mucosal resectionHierarchical composite endpointStakeholder-informed outcomes

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Area of Science:

  • Gastroenterology
  • Clinical Trial Design
  • Medical Innovation

Background:

  • Endoscopic mucosal resection (EMR) has advanced significantly.
  • Traditional EMR trial designs lag behind procedural progress.
  • Existing methods limit relevance and generalizability.

Purpose of the Study:

  • Review and assess current endoscopic mucosal resection (EMR) trial designs.
  • Identify limitations of traditional EMR trial methodologies.
  • Propose an innovative framework for future EMR trials.

Main Methods:

  • Literature review of EMR trial design approaches.
  • Analysis of limitations in current methodologies.
  • Identification of methodological innovations from other procedural disciplines.

Main Results:

  • EMR trial designs often use binary endpoints and limited stakeholder input.
  • Innovations like ordinal classifications and proceduralist-aware models can enhance trials.
  • Generalized pairwise comparisons and win ratios offer advanced analytic strategies.

Conclusions:

  • Improving EMR trials requires a shift in architecture.
  • Integrating stakeholder priorities, advanced analytics, and bias mitigation is crucial.
  • A modern framework will yield more meaningful and generalizable evidence for colorectal polyp resection.