How tech is driving health care
Medical research starts in the lab. New treatments, including drugs, are tested thoroughly before they move onto the next stage—the clinical trial. In order to ensure new treatments are safe and effective, they must be tested on people. These tests, called clinical trials, are conducted in stages, and each one of them is important.
In this gallery, we look at what clinical trials are, how they work, and explain each stage. Click on for more.
Clinical trials are conducted after thorough testing in the lab. Every treatment must be tested on humans before it can be used. Without clinical trials, these treatments would be a lot riskier, and, some, potentially fatal.
Clinical trials test new treatments. These can involve various things, including new drugs, vaccines, procedures, and diagnosis methods.
Clinical trials are conducted by a research team composed of medical professionals.
These are funded by a variety of people and organizations, from academic ones to private pharmaceutical companies, among others.
Clinical trials are usually divided into four stages. All clinical trial phases are important and must be considered.
How far a treatment is tested will increase as stages progress. This means that the earlier the stage, the less a treatment has been tested.
New medical advances usually go through the minimum of three main phases (one to three) to make sure the treatment is apt to be used in healthcare.
There are a number of things all clinical trial phases have in common. One of them is that tests are conducted on people.
In the case of randomized control trials, people are selected randomly and divided into two groups. One group is administered the actual treatment or the actual drug being tested.
The other group is given either no treatment (or a placebo drug), or they undergo a treatment that the new trialed treatment can be compared with.
The location, time, and circumstances of these clinical trials change, so people who participate in them can have very different experiences.
For example, these trials can be conducted in a ward, similar to those of a hospital. As for duration, they can take hours, weeks, or longer.
People might be either isolated or have contact with others. All this varies, depending on the trial in question.
The phases of a clinical trial build on each other. Each one essentially answers different questions, so a phase cannot be skipped.
For example, during a phase one clinical trial, a treatment may be tested for any side effects in the short term. A phase four trial would consider these side effects and test for the safety of long-term use.
During phase 0, low doses of a treatment are administered. Indeed, the doses are too small to measure if a treatment may or may not work. This initial phase is usually tested in groups of up to 20 people.
The main goal of a phase 1 clinical trial is to test if a treatment has any side effects on people. This is the first time the treatment is properly administered to people, so it’s a very important phase.
Phase 1 is all about determining the right dosage and best administration techniques and test for side effects.
This phase is usually conducted in a group of up to 50 people. It usually starts with small doses that may be increased, especially if no side effects are reported.
While phase 1 trials are conducted on healthy people, phase 2 clinical trials are all about testing the treatment on people who actually suffer from the condition the new treatment is aimed at.
With the minimal safety indicators guaranteed, phase 2 tests both safeness and effectiveness in people who may actually benefit from the treatment.
Phase 2 also tests for possible short-term effects. It involves a larger number of participants.
Phase 3 is when treatments are tested on a larger scale. This may mean testing it on thousands instead of hundreds of people.
Phase 3 clinical trials also last for considerably longer periods of time. These can run for over a year.
The variety, severity, and likelihood of side effects is tested on a large sample of people, and the results can be compared to those in the placebo group.
Phase 4 is usually the final stage of clinical trials. The goal is to assess the long-term benefits or risks of the treatment.
This is the case of drugs people have been taking regularly for years. A phase 4 clinical trial will look at how effective it was and any problems that may have arisen.
Phase 4 clinical trials take place after a treatment has been approved and available on the market. While not all treatments will undergo a phase 4 trial, those that require long-term use will.
Sources: (Patient.info) (The Royal Melbourne Hospital)
What are the phases of a clinical trial?
From zero to four
HEALTH Medical research
Medical research starts in the lab. New treatments, including drugs, are tested thoroughly before they move onto the next stage—the clinical trial. In order to ensure new treatments are safe and effective, they must be tested on people. These tests, called clinical trials, are conducted in stages, and each one of them is important.
In this gallery, we look at what clinical trials are, how they work, and explain each stage. Click on for more.