The World Health Organization (WHO) has proposed a master protocol for companies and institutions that aim to test therapeutics against SARS-CoV-2, the novel coronavirus that causes the respiratory disease, COVID-19. The WHO’s plan, which is part of its COVID-19 R&D Blueprint, borrows from similar designs in oncology and other outbreaks, such as Ebola.
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This question seems particularly appropriate in the midst of the coronavirus pandemic, given Dr. Anthony Fauci’s expressed support for a more rigorous investigational approach in response to a question about the published results of an open‐label non‐randomized clinical trial involving the use of hydroxychloroquine and azithromycin in treating patients with COVID-19. While neither anecdotal evidence nor observational research alone can justify the unquestioned endorsement of a novel interventional agent (based upon preliminary evidence of efficacy), the situation we face today does prompt us to ask the question that we at Worldwide often ask: Might a nontraditional but nevertheless methodologically rigorous approach to study design offer advantages compared to a conventionally structured clinical program, particularly for patients with significant unmet medical need?
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Please find below a message from Worldwide Clinical Trials’ President and COO, Peter Benton on COVID-19. In these challenging times, Worldwide Clinical Trials’ core mission – to work with passion and purpose every day to improve patient lives – has never been more important. As the spread of COVID-19 continues as a concern across the world, I want to assure you that Worldwide is taking all measures necessary to protect your corporate goals and objectives while safeguarding the welfare of patients, the investigative research centers that serve them, our partners and the health and well-being of our employees and your research teams. We recognize that things are changing rapidly now. But our team is rising to the occasion, and I am encouraged by the trust and resilience of our customers and partners as we face this challenge together with flexibility, creativity, contingency planning and constant communication. As part of our business continuity plans, Worldwide has activated a COVID-19 executive council comprised of leadership from all functional areas across the globe. This team meets daily to discuss and proactively plan for the impact of global, country, state and local updates, including: Guidance and updates from the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and the European Centre for Disease Prevention and Control (ECDC), among...
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The following blog explores Worldwide’s recommendation of six key strategies that can be adopted by CROs and sponsors to effectively manage patient and trial metrics using new data streams.
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Advancements of artificial intelligence into pharma research present opportunities for more efficient recruitment and enrollment processes for clinical trial stakeholders, while at the same time giving patients and caregivers greater access to research treatment options. Worldwide Clinical Trials, in its new partnership with Deep Lens, is pioneering efforts in AI-driven patient recruitment in oncology research.
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Worldwide Clinical Trials has partnered with SISCAPA Assay Technologies, a biotech company specializing in products and services supporting protein biomarker and target quantitation, to offer a fully automated immunoaffinity mass spectrometry workflow. This novel approach enables quantitation and characterization of proteins and peptides, bringing together aspects of mass spectrometry and immunoassays to enable precision measuring of proteins in less time and at lower cost than conventional immunoassays or LC-MS assays.
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