Drug trials are called Phase 1, Phase 2 or Phase 3.
Phase 1 trials only study safety. More trials cannot take place unless Phase I trials show a drug to be reasonably safe when given to humans. People in a Phase I trial are closely watched for any sign of harm caused by the drug. Because safety is the question, Phase 1 trials are small but they also allow researchers to start understanding how the drug will work in people. At this point in testing, no one even knows if the new drug will do what it is designed to do. Phase I trials are the most dangerous for patients.
Phase 2 trials confirm that a new drug is safe enough for more people to try, and show whether a drug is effective over the short-term. Phase 2 trials also help decide what doses will be used in Phase 3 trials. Phase 2 trials are usually placebo-controlled and double-blinded. Neither the patient nor the doctors know if a patient is getting the drug or a placebo . These trials are larger than Phase I trials and take longer. There is still significant risk because only a small group of people has tested the drug for safety so far.
Phase 3 trials prove or disprove the effectiveness and safety of a drug over the "longer" term. They are usually double-blinded and placebo-controlled. They can involve hundreds or thousands of patients over months or years. Although the number of patients can be large, risks for patients are smaller because of all the earlier testing. The large scope of these trials lets researchers observe benefits and overall safety of the drug as well as identify less common side effects. Phase 3 trials are incredibly expensive and only drugs which look very profitable make it to this type testing.
The Functional Assessment Rating Scales - FARS for adult behavioral health functional assessment (John , Jr., . & Michael G. Dow, ., 1994, 1996, 1997, 1998) & CFARS for child or adolescent behavioral health functional assessment (J. Ward, M. Dow, T. Saunders, S. Halls, K. Musanta, K. Penner, R. Berry, & N. Sachs-Ericcsson, 1996, 1997, 1998) are ways of documenting and standardizing impressions from clinical evaluations or mental status exams that assess cognitive, social and role functioning. The FARS and CFARS (adapted from the Colorado Client Assessment Rating Scales - CCAR) were developed for use in Florida to evaluate the Department of Children and Families (DCF) behavioral health outcomes for children and adults receiving state supported services.
I have suffered from being cold my entire life. I’m now 47. Several years ago I started my quest to see if there was any help for my symptoms which are as follows. Severely cold most of the time. Extremely cold hands and feet. Go to bed freezing and wake up in middle of the night drenched in sweat and of course back to freezing. Tired regardless of how much sleep I get, never feel energetic in the morning. I look at food and gain weight, so when I do eat I barely eat, I don’t smoke and rarely drink. Been tested for pre-menapasul, not it. Been blood tested for Thyroid and told all came back normal. Even had a Endocrinologist ask my why I was there and then they prescribed me Prozac, as if I was making this all up. It is so upsetting to look around a room of people who are so comfortable and I’m bundled up because I’m cold, or to be at the pool with my children the outside temp is 78 and it’s too cold for me to get in the water with them. Took my temp mid afternoon the last 2 days and it is . Is this normal? Is there any help?