Clinical trials save lives, millions of them. They are the method for determining safety and effectiveness of prescription drugs, medical devices and therapies. Treatments that survive the gauntlet of a clinical trial have been proven safe and effective using the best methods available.
That’s why you need to know more about clinical trials.
Four phases, designed with you in mind
First, safety. That’s what a Phase I clinical trial is all about. Once a therapy has proven safe in the lab, it is administered to a small, carefully selected group of patients in strictly controlled settings, solely to determine if it is safe in humans. Any doubt whatsoever and all further work ceases; the therapy is abandoned.
Then comes effectiveness. In Phase II, curative powers are tested on a somewhat larger patient group. Again, these trial subjects are carefully selected and intensely monitored, and the outcomes scrutinized by highly trained medical personnel. Phase II asks: Will it work? The answer must be at least ‘probably’ or the treatment is out.
Now it’s time for the acid test, Phase III. Here, the therapy is tested on a still-larger patient group to confirm lingering questions such as proper dosage, method of administration, safety, efficacy and more. Only after Phase III is deemed a success may the therapy go on the market.
But there’s still Phase IV to go. Now the therapy is out in the world, where things can go wrong despite the most rigorous tests. During Phase IV, this hopeful cure is being watched by thousands of eyes to make sure it fully meets its Phase III promise.
How we can all help in this time of great need
WCG plays a role at every stage of a clinical trial. It helps recruit patients, subjects and volunteers. We support doctors, researchers and analysts during each and every clinical-trial phase. It operates Independent Review Boards to provide outside oversight. These IRBs are made up of experts not associated with sponsors of the trial, parties who conduct it, or any other entity that stands to benefit from it.
Clinical trials are especially important as everyone works to slow the progress and blunt the dangers of COVID-19. There are things all of us can do to help the effort, and to give frontline healthcare workers and therapy developers vital breathing room to do their lifesaving work. The more you understand, the more you can help.
We are in this together. WCG will do its part, providing critical services to researchers, drug developers and hospitals, in the battle to develop new medicines and therapies to address novel diseases and disorders. This work is about patients. It always will be.