FOCU.SE

FOCUSE is an initiative by Testbed Sweden Precision Health Cancer, founded by Vision Zero Cancer, Genomic Medicine Sweden and SciLifeLab, involving regulators, policymakers, payers, researchers, healthcare providers, patient advocates, and industry to drive the implementation of precision health in cancer care.

The Swedish Precision Cancer Medicine Trial FOCU.SE

Enhance advanced cancer care in Sweden with a nationwide Precision Cancer Medicine trial.

The upcoming trial, inspired by the Drug Rediscovery Protocol (DRUP) family of trials, utilizes a prospective, non-randomized Simon two-stage design. Patients are selected based on thorough molecular profiling and closely monitored for residual disease.

Building on Swedish expertise in multi-omics and drug sensitivity screening, we aim to discover novel predictive biomarkers and therapeutic targets, leading the way for the next generation of precision medicine and improving clinical outcomes

Figure: Clinical Trial Patient Journey

  • A national clinical study platform contributing to DRUP-like trials.

  • Increased opportunities for rare cancer patients to test promising therapies.

  • Implementation of a national Molecular Tumour Board (MTB).

  • A biomarker research engine for basic research and innovative clinical trials.

  • Elevating Sweden as a clinical trial leader in precision cancer medicine.

EXPECTED OUTCOMES

DRUG REDISCOVERY

Drug rediscovery studies have proved an effective means to help individual patients to novel treatments and add new indications to existing targeted therapies. The application of precision medicine in clinical trials also helps refine processes and establish infrastructure for diagnosis, treatment, and follow-up, contributing to the successful implementation of precision medicine.

SHARED DRUP CORE TRIAL DESIGN

SIMON TWO-STAGE MODEL

  • Eligible patients with identified actionable targets with matching drug from the study portfolio will be included in a cohort.

  • A cohort will consist of patients with same indication and the same actionable target.

  • Multi-step evaluation of response.

MULTI-STAKEHOLDER COLLABORATION

Precision cancer medicine requires expertise from various fields. FOCUSE is an initiative by Testbed Sweden Precision Health Cancer, founded by Vision Zero Cancer, Genomic Medicine Sweden and SciLifeLab, involving regulators, policymakers, payers, researchers, healthcare providers, patient advocates, and industry to drive the implementation of precision health in cancer care.

STAKEHOLDER VALUE

  • Society: Equitable access to precision cancer medicine.

  • Patients: Added diagnostic and treatment options.

  • Clinicians: Expanded treatment choices.

  • Researchers: Possibility for basic research and translation of results into clinical practice.

  • Pharma: Introduction of new precision medicine indications.

  • Medtech: Validation of diagnostics and devices.

  • Policy makers: Opportunity to learn from an implementation model.

  • HTA: Real-world cost-effectiveness.

  • Payors: Access to precision cancer medicine for patients.

DLCT COMMUNITY

FOCUSE is part of a family of independent, investigator-initiated, pragmatic clinical trials in precision medicine inspired by the design of the original DRUP protocol. 

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