"Who Monitors Patient Safety During the Trials? "

Sponsors of each clinical trial must have a Data and Safety Monitoring Board (DSMB), as outlined by federal requirements.  This board consists of independent reviewers who analyze the incoming statistical data of patients actively on trial to insure the trial is stopped if its final objectives are met early, or if an arm of the study experiences safety concerns.  A popular misconception is that the pharmaceutical companies are intentionally withholding unfavorable toxicity data while a trial is underway to protect proprietary interests.  The DSMB has the independent authority to protect patient safety by reviewing data as it is collected in order to minimize risks and confirm data integrity.   Large phase III trials may employ an independent statistician who is the only one that can “unblind the code” to determine which study arm is superior.  A steering committee of oncologists that report to the DSMB may have access to the data to ensure safety and analyze adverse events.   If the trial proceeds safely, then the results may remain blinded until the objective goals of the trial are met.   Pharmaceutical sponsors often discover the trial results via an independent statistician, sometimes on the same day of a medical conference presentation (in order to reduce the opportunity for insider trading). 

            Throughout the trial enrollment period, the sponsoring pharmaceutical company sends a Clinical Research Associate (CRA) also known as a monitor for monitoring site visits.  Monitors serve as a liaison between the pharmaceutical sponsor and the trial site.  The monitor’s duty is to confirm that the trial is being conducted according to protocol with appropriate documentation of toxicity and adverse events by Good Clinical Practice Guidelines.   During the monitor visit to a trial site, source documents (medical chart) are referenced to case report forms (CRF) to confirm integrity and accuracy of the collected research data.  CRA/Monitors also meet with the Clincal Research Coordinators (CRCs) and investigators to discuss any wrinkles in the logistics of the protocol.  Pharmaceutical drug development teams and CRAs do not meet directly with patients.  That ensures the sponsor and monitor are effectively isolated from the patient to maintain confidentiality and objective data collection/interpretation.  Behind the scenes, CRCs and CRAs spend many hours compiling and analyzing data to confirm that it was obtained according to protocol and federal regulatory guidelines.