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Updated: Oct 12, 2025

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
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Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials

Raimondo Di Liello1, Maria Carmela Piccirillo2, Laura Arenare2

  • 1Oncologia Medica, Dipartimento di Medicina di Precisione, Università degli Studi della Campania "Luigi Vanvitelli", Via S. Pansini 5, 80131 Napoli, Italy.

Life (Basel, Switzerland)
|November 27, 2021
PubMed

Insights

Personalized medicine in oncology requires new clinical trial designs. Master protocols, including umbrella, basket, and platform trials, offer innovative approaches for targeted therapies.

Area of Science:

  • Oncology
  • Clinical Research Methodology
  • Genomics

Background:

  • Randomized clinical trials have historically driven oncology drug development.
  • Molecular and genomic profiling have shifted cancer treatment towards personalized, biomarker-driven therapies.
  • This paradigm shift necessitates evolving clinical trial methodologies.

Purpose of the Study:

  • To review innovative clinical trial designs for personalized medicine.
  • To describe master protocols (umbrella, basket, platform trials).
  • To discuss the opportunities and limitations of these designs in targeted therapy development.

Main Methods:

  • Review of emerging clinical trial designs.
  • Description of master protocol structures.
  • Analysis of their application in personalized oncology.

Main Results:

  • Master protocols represent a new standard in clinical trial methodology.
  • These designs efficiently evaluate multiple treatments and patient subgroups.
  • Umbrella, basket, and platform trials address unmet needs in targeted therapy development.

Conclusions:

  • Innovative trial designs are crucial for advancing personalized cancer medicine.
  • Master protocols offer flexibility and efficiency in evaluating targeted therapies.
  • Further exploration of master protocols is needed to optimize their use.
Keywords:
clinical trialsindividualized treatmentmethodologypersonalized medicine

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