Day in and day out, scientists worldwide are working hard to develop new potential forms of treatment for the many medical ailments that face our society. As part of ensuring the safety of any potential treatment, it must legally undergo clinical trial testing. Many people have heard of clinical trials, but are unsure as to what they actually do.
These trials allow for the treatment to be tested on humans with a particular health condition to determine a drug's effectiveness and safety for the general population. Before the drug is ever introduced into human patients, it undergoes testing on animals so that scientists are able to be alerted of any major side effects.
What is a Clinical Trial?
As the medicinal world develops more ways to treat known health conditions, new medications are coming out daily. To ensure that new formulas are safe for use on humans, clinical trials are enacted. Clinical trials are defined as research of a treatment or test given to subjects. The researchers are essentially giving patients an experimental drug to see if it treats their known health conditions. Clinical trials can be done for all the following circumstances:
- To Test A Drug Not Yet Approved By The FDA
- To Test A New Use Of An Existing FDA-Approved Drug
- To Test Out New Ways To Administer A Certain Drug
- Innovative Tests To Find Or Track Disease Progression
All clinical trials must be approved by an Institutional Review Board (IRB). An IRB is composed of top health officials at a health care facility where patients will be subjected to the trial. Each IRB must consist of five members, including a scientist, a non-scientist, and a member that doesn't work at the health care center.
When is a Clinical Trial Held?
Before a new drug or test reaches the general public, it goes through clinical trials. These are to prove their effectiveness and safety. However, before any clinical trials are held with public participants, the drug goes through what is known as the discovery phase. This is where scientists test the compound on animals to check for any side effects or severe reactions.
If the treatment is considered safe and effective on animals, it moves to the human clinical trial phase. Once the IRB agrees to approve a clinical trial, it can get underway. The discovery phase can take about three to six years to complete. The proceeding clinical trial phase can take about six to seven years to complete. Therefore, any one drug usually takes a minimum of 10 years from the point of its discovery until it's approved by the FDA for treatment of a human condition.
The Phases of a Clinical Trial
Each clinical trial will consist of three main stages. All of these stages must be performed according to the Good Clinical Practice (GCP) guidelines set forth by regulators. These are intended to help protect the safety of patients who are participating in the clinical trial.
- Phase 1 - The first stage of any clinical trial is done with a small number of participants. Usually, most phase 1 clinical trials will have around 10 participants who are specifically chosen by the board. In this stage, medical experts are looking to see how the body reacts to the treatment or drug. This is the stage where they can be alerted of any severe side effects.
- Phase 2 - After phase 1 is successfully completed, the clinical trial will move into phase 2. At this point, the drug is considered relatively safe so that more participants can showcase the overall result of the treatment or test. This phase is performed on a larger group of participants, generally ranging from about 30 to 300 people. Phase 2 focuses on varying the dosage to determine what is the ideal dosage for the majority of the participants.
- Phase 3 - The last stage of a clinical study is carried out on a large number of participants, ranging from 300 to 3,000. This final stage is to determine the overall safety and efficiency of the drug or test. Oftentimes, researchers may prescribe other known medications for a particular condition to some of their testers to see how effective the new drug is against the other ones.