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What are clinical trials? -

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.

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What do clinical trials test? -

Clinical trials test new treatments. These can involve various things, including new drugs, vaccines, procedures, and diagnosis methods.

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Who conducts clinical trials? -

Clinical trials are conducted by a research team composed of medical professionals.

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Who funds clinical trials? -

These are funded by a variety of people and organizations, from academic ones to private pharmaceutical companies, among others.

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What are clinical trial phases? -

Clinical trials are usually divided into four stages. All clinical trial phases are important and must be considered.

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A staged approach -

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.

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Minimal requirements -

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.

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Common factors -

There are a number of things all clinical trial phases have in common. One of them is that tests are conducted on people.

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Control groups -

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.

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Control groups -

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.

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Experience -

The location, time, and circumstances of these clinical trials change, so people who participate in them can have very different experiences.

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Experience -

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.

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Experience -

People might be either isolated or have contact with others. All this varies, depending on the trial in question.

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Why are clinical trials divided into phases? -

The phases of a clinical trial build on each other. Each one essentially answers different questions, so a phase cannot be skipped.

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How clinical trial phases build on each other -

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.

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Phase 0 clinical trials -

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.

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Phase 1 clinical trials -

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.

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Phase 1 clinical trials -

Phase 1 is all about determining the right dosage and best administration techniques and test for side effects.

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Phase 1 clinical trials -

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.

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Phase 2 clinical trials -

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.

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Phase 2 clinical trials -

With the minimal safety indicators guaranteed, phase 2 tests both safeness and effectiveness in people who may actually benefit from the treatment.

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Phase 2 clinical trials -

Phase 2 also tests for possible short-term effects. It involves a larger number of participants.

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Phase 3 clinical trials -

Phase 3 is when treatments are tested on a larger scale. This may mean testing it on thousands instead of hundreds of people.

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Phase 3 clinical trials -

Phase 3 clinical trials also last for considerably longer periods of time. These can run for over a year.

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Phase 3 clinical trials -

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.

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Phase 4 clinical trials -

Phase 4 is usually the final stage of clinical trials. The goal is to assess the long-term benefits or risks of the treatment.

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Phase 4 clinical trials -

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.

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Phase 4 clinical trials -

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) 

See also: The impact of fake studies on scientific research

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