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Clinical Trial News

COVID-19 Trial Reporting Lags, Hampering Research Efficiency

  • A systematic review reveals that the majority of registered COVID-19 trials have not reported results, hindering research progress.
  • Most published trials focus on hospitalized patients, leaving gaps in outpatient and preventative treatment evidence.
  • Data sharing among COVID-19 trials is limited, impeding collaboration and real-time guidance for healthcare professionals.
  • Many trials face recruitment challenges, raising concerns about statistical power and the validity of study findings.

Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study)

NCT04342182TerminatedPhase 2
Erasmus Medical Center
Posted 4/8/2020

FDA Grants Fast Track Designation to Remestemcel-L for COVID-19 ARDS Treatment

  • The FDA has granted Fast Track designation to remestemcel-L for treating acute respiratory distress syndrome (ARDS) due to COVID-19, addressing a critical unmet need.
  • Clinical data from a pilot study showed that 75% of ventilator-dependent COVID-19 ARDS patients were successfully discharged after remestemcel-L treatment.
  • A Phase 3 trial is ongoing, evaluating remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS, with mortality as the primary endpoint.
  • Mesoblast has partnered with Novartis for the development, manufacturing, and commercialization of remestemcel-L, initially focusing on ARDS treatment.

Colchicine, a Gout Drug, Enters RECOVERY Trial as Potential COVID-19 Treatment

• Colchicine, an anti-inflammatory drug used for gout, is being evaluated in the RECOVERY trial for its potential to treat hospitalized COVID-19 patients. • The RECOVERY trial, the world's largest clinical trial for COVID-19 treatments, will assess colchicine's ability to reduce the risk of death after 28 days in approximately 5,000 patients. • Colchicine's anti-inflammatory properties may help combat the excessive immune response seen in severe COVID-19, potentially preventing lung damage and reducing the need for ventilation. • The RECOVERY trial has already identified dexamethasone as effective in reducing mortality in severe COVID-19 cases and has ruled out other treatments like hydroxychloroquine.

Technological Advances and Patient Partnerships Drive New Era in Rare Disease Drug Development

• Changing economics and technological innovations, including machine learning, are transforming rare disease drug development from an economic no-go area to a viable pharmaceutical investment.
• Patient group partnerships and early engagement in drug development are proving crucial for trial success and cost reduction, with companies like Pfizer and Healx leading collaborative approaches.
• The rare disease landscape shows promising developments with over 7,000 identified conditions, driven by regulatory flexibility and increased patient advocacy involvement in research direction.

Gilead's $27 Billion Oncology Transformation: Strategic Deals Reshape Company's Future

• Gilead Sciences has executed over $27 billion worth of strategic oncology deals in 2020, marking its most aggressive push yet to establish leadership in cancer treatment.
• Under new leadership, including CEO Daniel O'Day and CFO Andrew Dickinson, Gilead has acquired Immunomedics for $21 billion and made significant investments in multiple biotech companies focused on immuno-oncology.
• The company aims to balance its traditional antiviral portfolio with a strong oncology presence, highlighted by the acquisition of Trodelvy, while maintaining approximately $11 billion for future strategic investments.

Integrated CBTI and PAP Adherence Program Improves Sleep and PAP Use in Veterans with Comorbid Insomnia and OSA

A randomized controlled trial demonstrated that a structured, manual-based intervention combining cognitive behavioral therapy for insomnia (CBTI) with a positive airway pressure (PAP) adherence program significantly improved sleep outcomes and PAP use among middle-aged and older veterans with comorbid insomnia and obstructive sleep apnea (OSA). The intervention, delivered by a sleep coach with weekly supervision by a behavioral sleep medicine specialist, showed sustained improvements at 3 and 6 months follow-up.

Havas Health & You Launches Global Research Initiative to Track Healthcare Evolution Post-COVID

  • Havas Health & You has initiated 'Behind the Mask', a comprehensive longitudinal study combining qualitative and quantitative research to document healthcare delivery changes during and after COVID-19.
  • The research reveals significant concerns among healthcare providers, with 79% of clinicians anticipating a COVID-19 resurgence, up from 70% in earlier surveys.
  • The project aims to build stronger health brands by capturing authentic healthcare provider experiences through auto-ethnography, including real-time documentation from doctors after lengthy shifts.

Cyclarity Launches Human Trial for Atherosclerosis

Cyclarity Therapeutics has initiated its first human clinical trial for atherosclerosis, focusing on its primary candidate cyclodextrin drug, UDP-003, marking a significant step in longevity and aging research.

NIHR and Pfizer Launch Initiative to Enhance Patient Engagement in UK Clinical Trials Design

  • The National Institute for Health Research (NIHR) and Pfizer have established a collaborative framework to facilitate patient engagement in clinical trial design while maintaining compliance with ABPI guidelines.
  • The initiative addresses key challenges in clinical trials including patient recruitment, retention, and protocol amendments, becoming particularly relevant with the shift toward remote and hybrid trial models.
  • A new Patient Engagement in Clinical Development service has been launched to help pharmaceutical companies build stronger relationships with patient advocates and improve commercial research design.

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