Breo Ellipta is associated with a lower rate of exacerbations in real world Salford study, but some analysts question whether it's too late to turn performance around in a highly competitive, highly price-conscious market.
GlaxoSmithKline PLC's Salford Lung Study of its Relvar/Breo Ellipta inhaler in chronic obstructive pulmonary disease breaks new ground as a prospective, randomized, controlled trial in everyday health care practice started prior to launch, though analysts question the commercial impact.
The Phase IIIb Salford Lung Study was designed as a real world safety and efficacy study of the once-daily product,...
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
