Another resource offered by the U.S. National Library of Medicine is the database of interventional and observational studies that can be found at http://www.clinicaltrials.gov. Interventional studies are also commonly called clinical trials, while observational studies do not involve any sort of intervention or treatment. Studies in all stages are listed on the website for anyone to view. At the time this issue went to print, there were 44 returns to a search for clinical trials with the keywords “Cushing’s Disease”. If there was a way to search for every instance of cortisol-related issues, that number would be in the hundreds. If you are interested in finding out if a particular type of trial might be available in your area, there is an advanced search option under “Find a Study” where you can get as specific as you want with your parameters. Even if you don’t find an exact match, you can tweak your search terms and probably change the outcome of the search. Along the way you will be offered many links to studies with titles that give you a glimpse into the world of science and proof that “someone” is most definitely “doing something”!
Trials occur in phases, or stages, based on study objectives, participants, and other factors (observational studies do not operate in phases):
- Early Phase 1: exploratory studies conducted before the traditional trials begin, involve very small doses of the drug and make no claims of therapy or diagnosis of any disease
- Phase 1: studies focused on the safety of a drug, usually conducted with healthy volunteers, main goal is to study adverse events, their frequency, and how the body breaks down and gets rid of the drug
- Phase 2: studies focused on gathering preliminary data in patients with the disease, frequently involve some patients receiving a placebo, measuring safety and adverse events still a priority
- Phase 3: studies that receive the benefit of data from the first few phases of trials and involve more participants across specific populations at different dosages, measuring safety and efficacy of the drug still a priority
- Phase 4: trials that occur after FDA approval of the drug that continue to gather safety and effectiveness data to ensure optimal use of the drug