The Clinical Trial Journey

Published by Darron Toy on

The clinical trial journey is how a
medical intervention such as a drug, device, or procedure moves from an idea
into patient care. The beginning of the journey starts with DISCOVERY SCIENCE. In the lab researchers use computer, cells and animal models to answer basic
questions, like “How does DNA work?” and “How do cells talk to each other?”
After a great deal of work this effort is ready to be translated into clinical
research this is the FIRST TRANSLATIONAL MOMENT. As they move into PHASE 1 CLINICAL TRIALS, researchers begin looking for answers with the help of
volunteers. Here, researchers answer questions about safety, and how well
participants tolerate the medical intervention. These trials don’t include
many volunteers and they are short, usually only a few months long. With
information collected in phase one, they move to the next phase. PHASE 2 CLINICAL TRIALS, researchers ask, “Is what I’m studying effective for patients with
this health condition?” Are there any side effects?” “How does it compare to a placebo?” Phase 2 trials are usually done with a medium-sized group of volunteers. The
studies can last for several months two years. Now the thing is it is common for
phase 1 or 2 trials to DEAD END here. Funding disappears. Results are
inconclusive. The intervention fails. When that happens,
researchers go back to the drawing board and try again. But when it does work,
researchers go to PHASE 3 CLINICAL TRIALS. In this phase they set out to
confirm the results of previous trials in a larger study. They ask questions
like, how does it compare to other treatments? How effective is it with a
lot more people? Phase 3 trials need years to complete. Beyond Phase 3 US
Food and Drug Administration approval is the next critical stage. The FDA reviews
all the trial data, taking into account the intervention’s intended
use. It must decide if the benefits outweigh the risks. Once an intervention
gets approval, it is ready to become a treatment for patients. FDA approval
means the clinical trials journey has reached THE SECOND TRANSLATIONAL MOMENT. The intervention is no longer a science experiment. But the journey doesn’t end there. As it’s used by more and more people,
monitoring ensures the treatment is still safe and effective.

1 Comment

Dr. Mallak · October 23, 2019 at 1:54 pm

Very helpful.

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