Following the Phases of Clinical Trials

New drugs presented to the market for patient use are heavily tested and regulated before they can ever reach a patient’s hands. The reason these trials are completed is to ensure that drugs and treatments are safe for patients, regulating the drugs and understanding any side effects that might appear during the use of a drug. This clinical research — Alzheimers research studies or paid depression studies — is essential for the long-term testing of drugs, seeing whether it is beneficial in treating diseases, and how effective it is across large populations of studied individuals.

Research-based pharmaceutical companies spent nearly $150 billion on research and development in 2017. While this might sound like a great deal of money spent, it comes at a good cost. Thanks to the pharmaceutical industries research and ingenuity, new drugs and treatments are presented, most of which help to prevent and cure deadly diseases (such as Hepatitis C). The benefit to this research is that not all drugs reach the market.

While this might sound strange, considering that you would want the highest rate of positive research, the upside is that only the best drugs end up reaching the market. Clinical trials usually only have a probability of success (POS) of just over 20%, while oncology drugs have a POS just over 3%. This means that patients are receiving drugs that have been heavily tested and researched, guaranteeing that they are safe as treatments, all with little to no side effects. So, in that case, what are the stages of clinical trials?

Phase 0 Clinical Trials

Sometimes skipped during clinical trials, these are small group research trials (only 10 people) in which the oral bioavailability and half-life of the drug is tested and determined.

Phase 1 Clinical Trials

This is the stage in which the drug is tested on healthy individuals to understand dosage. This will determine whether or not the drug is safe for patient use, checking for basic efficacy dependent upon dosage. The drug is usually on used on 20 to 100 people at this time.

Phase 2 Clinical Trials

Now tested on approximately 100 to 300 patients, the drug is tested to see if it has any efficacy on patients health. The drug, at this point in time, is not considered to have any effectiveness, so it is watched closely by researchers to track the possible effectiveness of the drug, along with any side effects that might arise.

Phase 3 Clinical Trials

Phase 3 clinical trial drugs are tested once again, but now on a much larger pool (approximately 300 to 3,000 people with specific diseases). These phase 3 clinical trial drugs are still being researched for their efficacy on humans, but rather than testing just for side effects they are now testing the phase 3 clinical trial drugs for long-term effectiveness and safety. At this point in the study, phase 3 clinical trial drugs are determined to have some sort of effectiveness, but they are particularly being tested for their therapeutic effect.

Phase 4 Clinical Trials

Following the testing of phase 3 clinical trial drugs, clinical researchers move the drug onto its last stage of research. This is the final stage of clinical research, where the drug is tested under postmarketing measures — watched under public use. Anyone who wishes to test the drug can choose to do so with their doctor, and clinical research centers will continue to watch the drug’s effectiveness, now for the long-term.

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