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Oncology Sponsors Getting A Jump On Pediatric Study Requirements, US FDA Says

 
• By Sue Sutter

Beginning in August 2020, applications for some novel cancer drugs and biologics will have to include reports on molecularly targeted pediatric investigations; agency is already working with sponsors on pediatric study development plans and expects to issue two draft guidances soon.

Child patient with IV line in hand sleep on hospital bed with hands of mother or doctor holding together to support ill daughter.Medical palliation healthcare concept

The US FDA is helping sponsors get a jump on pediatric cancer study requirements that take effect in August 2020 and is close to issuing two new guidance documents explaining how those provisions will be implemented.

Under the RACE for Children Act provisions that were included in the FDA Reauthorization Act, applications for novel drugs and...

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Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

US FDA Rare Disease Hub RISEs After Slow Start

 
• By Michael McCaughan

The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
• By Manas Mishra

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

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UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
• By Anabel Costa-Ferreira

Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.