What Constitute The Phase 1 Clinical Trial Research Studies

During medical research studies, doctors conduct different levels of clinical trials to analyze a particular treatment or a possible medical intervention and these clinical trials include four phases of research. With the early phase looking at the safety of a drug and its side effects, it’s in the later stage of this phase where a sample size is increased and tests conducted for more information on a trial drug.

The types of phases involved in clinical research are Phase 1 , Phase 2. Phase 3 and Phase 4.
What is involved in Phase 1 Clinical trial?
In this phase of clinical drug development, a clinical trial is conducted to test a new drug or treatment. It incorporates a small group, a small sample size in its trials to determine the research efficacy. This group is administered with small quantities of the drug under test, and the later groups will receive an increased amount of that drug, that’s if the first group responded well to the dose they were administered to. The mode in which doses of the new drug is gradually increased across the different test groups is known as, dose escalation study.

Here, the goal is to establish the right dose that will work efficiently without causing drastic side effects on the sample size. Several tests are conducted in order to achieve the desired test result. In this phase, doctors administer the new treatment through a vein or by mouth, and it’s when they’ll collect data on how the body responds to the test drug. They’ll check on drug absorption, drug utilization and how it spreads in the body. Since this phase of clinical study involves small sample sizes and test group, it takes significant a long time to complete and so often it last up to a year.

However, in phase 1 clinical trial, there are some circumstances when a clinical patient condition worsens after the administration of the test drug, most common cases are patients ailing from terminal cancer or HIV. Doctors have to remedy the situation using alternative drugs. Test and monitoring of patients are done around the clock with patients receiving a 24-hour medical attention. Volunteers who are the trial groups are paid according to the length they took research. The idea is to cater for any inconvenience caused to them.

There are also three kinds of phase 1 clinical trial and they include Single ascending dose, multiple ascending dose, and food effects. Basically, these are progress levels conducted in the entire phase 1 clinical trial. From this phase, the new test drugs can move to the next stage which is phase 2 clinical trials.