Has the FDA fallen short with its new draft guidance for paediatric clinical trials?
While useful for some agency divisions and novice professionals in paediatric research, most of the points made in the draft guidance are already in practice.
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Urtė Fultinavičiūtė
Urtė Fultinavičiūtė is a healthcare reporter for Clinical Trials Arena. Urtė's coverage focuses on clinical data management and clinical strategy.
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Burgeoning blockchain pilots to prove value in clinical trials
Blockchain technology is becoming more relevant in the face of increasing patient-generated data and data ownership.
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Multiple monkeypox vaccine and antiviral trials are launching across the world
While clinical trial designs are tackling bigger picture questions, more detailed aspects will have to be tested eventually.
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Can AI remedy the growing pains of digital biomarker development?
AI implementation could be a useful tool to analyse generated data. Yet, regulatory approval hurdles are in sight.
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Rough diamonds: hiring Gen Z to become future clinical trial experts
Millennials and Gen Z can bring in fresh ideas but time and investment from hiring companies is required.
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Hepatitis B: can GSK’s bepirovirsen deliver functional cure?
GSK’s antisense oligonucleotide is looking to further prove its value in disrupting viral replication via a Phase III test.
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Arcellx shares Phase III CAR-T design plans in earlier line multiple myeloma
While a Phase II CART-ddBCMA trial in later-line multiple myeloma has yet to start, Arcellx is already planning a…
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No time to delay: sponsors need to act fast ahead of CTIS deadline
With all new clinical trial applications expected to go through the new system from January 2023, CTIS uptake is…
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Cullinan Oncology previews Phase IIb NSCLC trial planned for end of year start
CMO Jeff Jones shares Cullinan’s blueprint for an upcoming Phase IIb trial recruiting non-small cell lung cancer patients with…
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