As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards ...

Regardless of a study’s prespecified protocol deviation reporting procedures, investigators should report protocol deviations in a way that highlights important protocol deviations.

Clinical Protocol Activation Process Navigating the Clinical Protocol Activation Process for Industry-Written and Sponsored Clinical Trials The flowchart and steps below outlines the best practice for ...

Clinical Trial Protocol is the basis for all clinical trials and it gives detailed information about the trial.

In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes.

BioVie has blamed "protocol deviations" at a number of clinical trial sites for the failure of a potential Alzheimer’s disease drug.

Approval for the Phase III protocol of LAE002 Plus LAE001 come as a result of posiive Phase II data, which showed promising benefits for metastatic castration-resistant prostate cancer (mCRPC) ...

A protocol is the detailed plan of a trial. It outlines how the trial will be run. A group of people who are not involved with the trial should review and approve the protocol. When research teams ask ...

The Callisto Protocol is the latest game to join the PlayStation Plus trials program, granting subscribers unfettered access to Striking Point Studios' horror game for an hour before buying.

Introduction Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI ...