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Clinical Trial News

India Modernizes Clinical Trial Process with Digital System and Mandatory AV Consent Recording

  • India's Central Drugs Standard Control Organisation (CDSCO) launches new IT-enabled system to streamline clinical trial applications, improving transparency and efficiency in trial registration process.
  • Mandatory audiovisual recording of informed consent has been implemented across 90% of Indian trial sites, addressing previous concerns about participant protection and ethical standards.
  • The initiatives aim to bridge the gap between Indian and international clinical trial standards, leveraging India's vast treatment-naïve population of over a billion people across 500+ sites.

Smoking Poses Heightened Health Risks for HIV Patients, Studies Show

  • Recent studies reveal that people living with HIV who smoke lose more years of life from smoking than from HIV itself, with 50-70% of HIV-positive individuals being smokers.
  • Smoking significantly increases HIV patients' risk of opportunistic infections, cardiovascular disease, and medication complications, with up to 60% higher mortality rates observed in smokers.
  • Public health initiatives like Stoptober and e-cigarette adoption are being promoted as harm reduction strategies, with evidence showing e-cigarettes carry only 5% of tobacco's health risks.

FDA Draft Guidance Clarifies Requirements for Confirmatory Trials Under Accelerated Approval

  • The FDA has issued draft guidance on accelerated approval, focusing on when confirmatory trials must be 'underway'.
  • This guidance interprets 'underway' and details factors the FDA will consider before granting accelerated approval.
  • The guidance aims to ensure timely completion of confirmatory trials, as mandated by the Consolidated Appropriations Act of 2023.
  • Stakeholders can submit comments on the draft guidance until March 10, 2025, for consideration by the FDA.

Fulvestrant Shows Overall Survival Benefit Over Anastrozole in First-Line Advanced Breast Cancer

• A phase II trial (FIRST) comparing fulvestrant 500 mg to anastrozole 1 mg in postmenopausal women with ER-positive advanced breast cancer showed a statistically significant improvement in overall survival (OS). • Patients treated with fulvestrant 500 mg had a median OS of 54.1 months compared to 48.4 months with anastrozole, representing a 30% reduction in mortality risk (HR 0.70, P=0.04). • The OS benefit with fulvestrant was generally consistent across pre-specified subgroups, and no new safety concerns were identified during the follow-up period. • These findings suggest fulvestrant 500 mg could be considered as a first-line treatment option for ER-positive advanced breast cancer, especially where access to other therapies is limited.

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

NCT01740427CompletedPhase 3
Pfizer
Posted 2/22/2013

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

NCT01602380Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/17/2012

NICE Provisionally Approves BioMarin's Vimizim for Ultra-Rare Morquio Disease with Real-World Data Requirements

• NICE has issued a provisional approval for BioMarin's Vimizim (elosulfase alfa), priced at £395,000 per patient annually, for treating the ultra-rare Morquio disease affecting 88 patients in England.
• The approval is contingent on implementing real-world data collection and establishing a price cap, marking NICE's innovative approach to managing high-cost rare disease treatments.
• The MPS Society welcomes the decision while expressing concerns about further delays in the approval process, as patients urgently await access to this life-changing therapy.

FDA Approves Two New Ustekinumab Biosimilars, Bringing Total US Biosimilar Count to 65

Monoclonal AntibodyDrug Approval
  • The FDA has approved Biocon's Yesintek (ustekinumab-kfce) and Celltrion's Steqeyma (ustekinumab-stba) in November and December 2024, expanding treatment options for autoimmune conditions including Crohn's disease and psoriasis.
  • Of the 65 FDA-approved biosimilars, 14 have received interchangeable designation, allowing pharmacists to substitute them for reference products without prescriber intervention, enhancing patient access to more affordable treatments.
  • The biosimilar landscape continues to evolve with products spanning five major classes: insulin, granulocyte colony-stimulating factors, monoclonal antibodies, TNF-alpha inhibitors, and VEGF inhibitors.

Ropeginterferon Alfa-2b Shows Promise in Polycythemia Vera Treatment

  • Ropeginterferon alfa-2b demonstrates a high overall response rate of 90% in polycythemia vera (PV) patients, including complete and partial hematologic responses.
  • The study found no dose-limiting toxicities with ropeginterferon alfa-2b, supporting its favorable safety profile and potential for long-term use.
  • Treatment with ropeginterferon alfa-2b led to significant reductions in JAK2 V617F allelic burden, indicating molecular responses in PV patients.
  • The research suggests that ropeginterferon alfa-2b could effectively normalize blood cell counts and prevent thromboembolic complications in PV patients.

Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera

NCT01193699CompletedPhase 1
AOP Orphan Pharmaceuticals AG
Posted 8/1/2010

Europe Emerges as Leading Hub for Precision Medicine Innovation and Implementation

  • Europe's healthcare systems are rapidly adopting genomic medicine and personalized therapies, driven by collaboration among providers, payers, and pharmaceutical companies across the continent.
  • The convergence of advanced diagnostics, genetic analytics, and companion diagnostics has created a mature ecosystem for precision medicine delivery in everyday clinical practice.
  • European institutions' willingness to share platforms and data while maintaining security standards positions the continent to potentially surpass the US in precision medicine commercialization.

AstraZeneca Expands Immuno-Oncology Portfolio with Three Strategic Partnerships

• AstraZeneca secures rights to Inovio's INO-3112, a DNA vaccine targeting HPV-related cancers, in a deal worth up to $727.5 million, planning combination studies with durvalumab.
• MedImmune partners with Heptares on adenosine A2A receptor antagonist HTL-2071 for $510 million, aiming to enhance T-cell anti-cancer activity.
• A collaboration with Mirati Therapeutics will explore combining durvalumab with HDAC inhibitor mocetinostat in non-small cell lung cancer trials starting next year.

India Revamps Clinical Trial Regulations to Align with Global Standards

  • India has significantly reformed its clinical trial regulations, extending SAE reporting timelines from 10 to 14 days to match international standards and streamlining the approval process.
  • The regulatory framework now requires trials to be evaluated based on risk-benefit assessment, innovation value, and unmet medical needs in the country, ensuring greater transparency.
  • New draft standards for accreditation of sites, investigators, and ethics committees have been introduced by CDSCO, aiming to enhance operational standards across clinical research.

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