Transparency on trial

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Interview: The evolution of data management in clinical development

By Liza Laws

Gen Li is president and founder of Phesi, and OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and...

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Five decentralized clinical trial organizations raising big VC cash

By Jonathan Smith

Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture capital...

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FDA approval expands Welireg to patients with renal cell carcinoma

By Jonathan Smith

The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).

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Europe launches initiative to transform clinical trials

By Rachel Arthur

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.

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FDA lead calls for independent inquiry into Biogen drug approval

By Jane Byrne

Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....

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FDA update on COVID-19 actions and advisements

By Jenni Spinner

Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.

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Judge: Feds must open trial data access

By Jenni Spinner

A judge has ruled in favor of parties seeking to broaden access to federal clinical trial information, helping close a long-standing loophole.

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The potential of blockchain for clinical trials

By Ben Hargreaves

Due to the imperative for secure communication between stakeholders organizing clinical trials, a recent report suggests that blockchain technology could be a ‘perfect’ solution.

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