Patient safety

Final Rule 'modernizes' protections for clinical trial participants

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The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.


Packaging design: how to ensure successful patient outcomes

Two more patients die in trial of Juno's JCAR015

Two more patients die in trial of Juno's JCAR015

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Teleflex recalls faulty nasal delivery devices used to administer opioid overdose meds

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Researchers question traditional efficacy trial model

Adaptive designs allow for modifications during a study, without compromising integrity or validity. (Image: iStock/Incrivelfotos)

Adaptive designs: patient value and commercial benefits

A draft of the revised guideline is expected to be published before the end of 2016. (Image: iStock/ALotOfPeople)

EMA proposing changes to FIH clinical trials, accepting comments

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Juno submits 'Complete Response' to FDA following 3 deaths in ph II trial

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Fatality in clinical trials: DIA panel discusses FIH trials

Improved patient understanding helps reduced risk in clinical trials. (Image: iStock/AndreyPopov)

'Industry-first' electronic consent platform reduces risk, says CRF Health

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