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Clinical Trial News

Risk-Based Monitoring Revolutionizes Clinical Trial Quality Management

  • TransCelerate Biopharma's Risk-Based Monitoring Initiative is transforming clinical trial oversight by shifting from traditional on-site monitoring to a more targeted, data-driven approach.
  • The initiative provides comprehensive tools and frameworks for implementing RBM, including updated risk assessment tools and guidelines for source data verification and review.
  • Implementation of risk-based monitoring strategies aims to enhance patient safety, improve data quality, and potentially reduce costs across clinical trials.

New Research Reveals Key Strategies for Identifying and Engaging Pharmaceutical Industry's Rising Stars

  • Key opinion leaders emphasize that identifying rising stars should focus on innovative research and novel approaches rather than just publication counts or academic credentials.
  • Cultural and geographical factors significantly influence rising star development, with emerging markets like Brazil, India, and Turkey showing particularly strong potential for new talent.
  • Pharmaceutical companies are advised to implement specific strategies including dedicated advisory board positions and targeted support programs for emerging markets and underrepresented groups.

EMA Launches PRIME Initiative to Accelerate Access to Breakthrough Medicines in Europe

• The European Medicines Agency has introduced PRIME (PRIority MEdicines), a new fast-track program designed to match the FDA's Breakthrough Therapy Designation and expedite access to promising new drugs.
• The initiative offers enhanced scientific support and early dialogue with developers, aiming to reduce both development and regulatory approval times for medicines addressing unmet medical needs.
• PRIME will run parallel with ADAPT SMART program, incorporating early engagement with health technology assessment bodies to address pricing and reimbursement challenges in European markets.

Lenalidomide Approved as First-Line Therapy for Multiple Myeloma

  • The FDA approved lenalidomide (Revlimid) in combination with low-dose dexamethasone as a first-line treatment for multiple myeloma in 2015.
  • The approval was based on the Phase 3 FIRST trial, which demonstrated improved progression-free and overall survival compared to melphalan, prednisone, and thalidomide (MPT).
  • Lenalidomide is an oral immunomodulatory agent that inhibits proliferation and induces apoptosis of hematopoietic tumor cells, enhancing T-cell and NK-cell immunity.
  • Common adverse reactions associated with lenalidomide plus dexamethasone include diarrhea, back pain, asthenia, and rash, with warnings for hematologic toxicity and thromboembolism.

VIPER Trial: Evaluating Surgical Strategies for Pseudophakic Retinal Detachment

  • The VIPER trial investigates the efficacy of adding an encircling band to 20G vitrectomy for pseudophakic retinal detachment (PRD).
  • The study also explores whether 23/25G vitrectomy is non-inferior to 20G vitrectomy without an encircling band for PRD treatment.
  • The primary endpoint is the absence of any need for additional retina re-attaching surgical procedures during the follow-up period.
  • The trial uses a multi-center, randomized design to compare different surgical approaches for managing PRD.

FDA Grants Breakthrough Therapy Designation to Adaptimmune's T-Cell Therapy for Synovial Sarcoma

  • The FDA granted Breakthrough Therapy designation to Adaptimmune's affinity-enhanced T-cell therapy targeting NY-ESO for synovial sarcoma, expediting its development.
  • The designation was based on Phase I/II trial results showing a 60% response rate in patients receiving the target dose of engineered T-cells.
  • Adaptimmune's therapy targets HLA-A201, HLA-A205, or HLA-A*206 allele-positive patients with inoperable or metastatic synovial sarcoma.
  • The company plans to initiate pivotal studies with the NY-ESO-targeting T-cell therapy around year-end 2016, exploring its potential in other cancers.

Tetanus Shot Enhances Survival in Brain Tumor Immunotherapy

A study led by Duke Cancer Institute researchers reveals that a tetanus booster significantly improves the effectiveness of a vaccine therapy for glioblastoma, a lethal brain tumor, by enhancing the immune system's response. This innovative approach has shown to dramatically increase patient survival rates, with half of the treated patients living nearly five years or longer.

Study Evaluates Intra-arterial Tenecteplase Following Endovascular Therapy for Acute Stroke

A new clinical trial, ATTENTION-IA, is investigating the efficacy and safety of intra-arterial tenecteplase after successful endovascular therapy (EVT) in patients with acute posterior circulation large or medium vessel occlusion. The trial aims to improve outcomes for stroke patients by addressing persistent distal hypoperfusion and microcirculatory obstruction, common issues even after successful EVT.

Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation

NCT05684172CompletedPhase 2
The First Affiliated Hospital of University of Science and Technology of China
Posted 1/24/2023

Phase 1b Trial of Dostarlimab Combinations Shows Promise in Advanced Solid Tumors

A phase 1b clinical trial, IOLite, evaluated the safety and efficacy of dostarlimab in combination with niraparib or carboplatin–paclitaxel, with or without bevacizumab, in patients with advanced solid tumors. The study found these combinations to be safe and tolerable, with promising antitumor activity. The trial established recommended phase 2 doses for each combination and observed no new safety signals. Tumor response rates were encouraging, particularly in combinations involving bevacizumab, suggesting potential for further investigation in larger, randomized phase 3 studies.

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

NCT02657889CompletedPhase 1
Tesaro, Inc.
Posted 4/15/2016

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

NCT03307785Active, Not RecruitingPhase 1
Tesaro, Inc.
Posted 10/12/2017

FDA Approves Three Novel Therapies for Relapsed Multiple Myeloma

  • The FDA approved daratumumab (Darzalex) as a monotherapy for multiple myeloma patients who have undergone at least three prior treatments.
  • Ixazomib (Ninlaro), a proteasome inhibitor, was approved for relapsed multiple myeloma patients after one prior treatment, showing improved progression-free survival.
  • Elotuzumab (Empliciti) received approval for patients with one to three prior therapies, demonstrating extended progression-free survival when combined with lenalidomide and dexamethasone.

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