In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.
Researchers have published new international guidelines for the inclusion of patient-reported outcomes in clinical trial protocols with the goal of providing high-quality evidence and enhancing patient care.
Massachusetts biopharma companies received $2.9bn in venture capital investment in 2016 – and as pressure continues to accelerate the drug development process, manufacturers will continue to turn to CROs and CMOs, says MassBio.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.