According to Pharmaceutical Research and Manufacturers of America, it takes a new drug an average of 10 years to get from concept to approval, in large part because of the amount of testing it must undergo. This testing, called clinical research or clinical trials, is generally done in various phases. These phases are commonly called “Preclinical” to “Phase 4” which encompasses all of the pre-trial preparations through launch and continued monitoring.
What is it like to participate in a trial?
As a participant in a Phase 1 trial, you will help research staff understand the way the particular treatment interacts with the body at various doses and, depending on the study, how that’s altered by things like diet or interactions with other drugs. Generally, healthy volunteers will be included in these studies and monitored for a few days by research staff. Some studies are longer or require one or more follow-up visits.
DaVita Clinical Research conducts both Phase 1-2a in-patient trials as well as Phase 2b-3 outpatient trials. Each study is different, but the Phase 1 trials usually involve relatively small (sub-therapeutic) doses of treatment to determine safety to move forward to Phase 2 testing. In most Phase 3 trials, therapeutic doses of the drug are given to patients with the condition being studied, to monitor both safety and efficacy; these trials are usually done on an outpatient basis. Safety is the biggest priority for DaVita Clinical Research meaning that studies are carefully monitored, all information is given to participants up front, and a professional medical staff is constantly involved to monitor participants.
How you directly impact drug development
All phases of drug development are important for the development of new drugs with potentially life saving benefits. With your participation in early phase trials researchers get a better understanding of the trial treatment and its effect on the body in lower doses so that they can proceed to test it in later trials. In later phase research, researchers get a better understanding of how the drug works in actual patients.
Without the participation of these research volunteers, the treatment would never make it to the public to help those in need. Find out more about how you can directly benefit drug development by contacting a DaVita Clinical Research recruiter.
Disclaimer: Phase 1 (in-patient) clinical trials are not intended to treat a disease or condition. Phase 3 (out-patient) clinical trials may help treat an existing disease or condition. The information presented in this blog may be referring to either a phase 1 clinical trial or to a phase 3 clinical trial or to both. If you contact us regarding a trial, be sure to speak with the recruiter about whether or not the trial is intended to treat a condition.