Data Integrity

Compromise Near on EU Trial Regulations

With EU lawmakers and the European Council expected to reach a compromise on the Clinical Trial Regulation before Christmas, pharma, researchers and patient groups are pleading with them to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More

FDA Relaxes Avandia Restrictions

Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More

GSK’s Heart Drug Flops in Phase III Clinical Trial

GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More

AZ Faces DOJ Probe Into Brilinta Trial

The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More

Patients Would Get Data ‘Erasing’ Powers Under EU Proposal

A proposal moving through the European Parliament to centralize data protection across member states would grant clinical trial participants the ability to demand that their trial data — including data shared between regulators and other entities — be effectively “erased.” Read More

FDA Pressuring Sponsors to Go Digital in Case Report Forms

The FDA is leaning on sponsors to convert from paper to electronic capture of clinical trial source data, saying the change should help eliminate unnecessary duplication of data and transcription errors and promote real-time access to data for review. Read More