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Genomics-Driven Trials Built To Be Fast And Flexible

 
• By Bridget Silverman

Pioneering enrollment strategies are coupled with adaptive statistical designs in the next wave of basket trials from NCI, ASCO and Novartis.

Drug candidates aren't the only innovations being tested in a wave of trials using new "basket" designs. Three large-scale basket trials are gearing up that will be crucial tests of a paradigm-shifting approach to clinical trial conduct and enrollment.

The trials – the National Cancer Institute-MATCH study, Novartis AG's SIGNATURE program, and the American Society for Clinical Oncology's...

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EMA Mapping RWD Landscape To Bridge Evidence Gap For Duchenne Drugs

 
• By Vibha Sharma

A new EU study will assess the potential of existing Duchenne muscular dystrophy patient registries and other real-world data sources to address regulatory questions for emerging therapies.

US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

In Partnership with FDA

CDER Center for Clinical Trial Innovation (C3TI)

Discover how FDA’s C3TI is advancing clinical trials and creating new opportunities to shape the future of drug development.

Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

 
• By Neena Brizmohun

Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.

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Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

Rese-Cel CAR T Therapy Secures EMA PRIME Designation

 
• By Neena Brizmohun

Cabaletta’s rese-cel is among the latest investigational drugs that have won a place on the European Medicines Agency priority medicines scheme. Meanwhile, 11 products were denied PRIME designations.

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

The Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.