PATIENTS

WHAT IS DONE TO PROTECT PATIENTS DURING A CLINICAL TRIAL?

New product clinical trials cannot go forward without appropriate government approvals for the country in which they are being tested. Prior to giving approval, government health agencies require drug and device makers to submit safety data as well as any available data from earlier trials of the same product.

Likewise, before they can begin enrolling patients, doctors and hospitals involved with clinical trials must obtain approval on the way each trial has been designed and will be conducted. This approval must come from a local Institutional Review Board (IRB) or Ethics Committee (EC) which is made up of medical professionals and community leaders who are not involved with running the trial and are therefore unbiased. The IRB or EC also has responsibility for supervising the trial once it has started and, along with doctors conducting the trial, can stop it any time they feel patient safety is at risk.

Doctors who are enrolling patients in a trial are regularly monitored by outside personnel to ensure they are following the approved protocol and are properly gathering and reporting the needed data on patients before, during and after they are enrolled and are receiving or have received the product being tested.

An independent data monitoring committee (DMC) or data safety monitoring board (DSMB), which is made up of medical professionals and statisticians, regularly reviews data being reported for patients in the trial, and has the power to recommend the trial be terminated in the event patient safety becomes at risk.