The Clinical Trials Transformation Initiative, a public-private partnership between Duke University and the FDA, has created a list of four recommendations related to quality by design (QbD) for clinical trials.
The debate continues over how to optimize clinical trials, with some experts calling for incremental changes to combat inefficiencies while the FDA’s deputy commissioner says the industry is at a “tipping point.”
Quintiles subsidiary Novella Clinical and the academic research arm of the Cardiovascular Research Foundation (CRF) are collaborating to offer pre-clinical to post-market trial services to developers of cardiovascular drugs and devices.
The latest draft revisions of the Declaration of Helsinki (DoH) weaken protections for trial participants in low and middle income countries, Rafael Dal-Ré, director of clinical research at Universidad Autónoma de Madrid, and other researchers argue.
Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.
US eClinical firm Phase Forward has created the new executive role, “chief privacy officer,” to ensure it complies with the latest data protection and privacy regulations governing the trial sector.
