Clinical Trials

We are hearing a lot about clinical trials in the media at the moment. Trials underway to test new drugs are normally completed in four phases. Should a treatment be successful in the first stage, it will pass to phase II and so on followed by a study conducted after approval by regulators.

Pre-clinical phases of a drug or device involves testing on non-human cells that provide information about how effective it is, the problem of toxicity and how this impacts the drug or device.

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Phase I involves the testing of drugs on healthy human volunteers in a clinical trial, with small doses at first and subsequent increases in the dose further on but still at lower than the therapeutic dose. A small group of healthy volunteers will be invited to the clinic for clinical trials, so that they can be observed around the clock. Sometimes labs need to move where the funding is. For Lab Relocation Services, visit a site like Aport Global, providers of Lab Relocation Services.

Phase II involves the testing of a drug or device on patients to whom the compounds might benefit to assess the efficacy and possible side effects. These patients will receive what is known as a therapeutic dose.

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Phase III involves testing on patients to measure how effective it is and its safety. This phase involves a group of randomized patients to measure how useful this drug in everyday clinical practice. This measure is the part that takes the longest and is the most expensive of all the phases.

Stage IV is the stage after a drug or device has received approval by the regulatory board but continues to be monitored in the community.

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