Did you know that it often takes 15 years for a new drug to get through the medical research studies and hit the pharmacies for use by the general public? Modern medicine is an incredible tool that we are fortunate to have, but the powerful ingredients used in medication might have include devastating side effects, that are sometimes worse than the illness they are even treating. The rigorous clinical drug development process is designed protect the integrity of the pharmaceutical industry, so that patients can have confidence in the medication they take.
The primary mission of the clinical study process is to answer these three questions:
- How effective is the medication for accomplishing its intended purpose?
- What dosage provides the maximum benefits with minimum side effects?
- Is the medication safe for consumption?
So what is involved in the 15 years it takes to answer these questions? Generally, clinical trials are broken into three phases:
- Phase 1 Clinical Trials
The main purpose of phase 1 clinical trials is to establish that the drug or treatment is safe for human use, and to determine the ideal timing and dosage of it. Phase 1 clinical trials begin after the drug has been tested and exhibited positive results in animals. The patients who participate in the phase 1 clinical trials are often the first humans who are exposed to the new medication or medical treatment that is being tested.
The doctors who conduct phase 1 clinical trials usually approach it with a process called “escalation.” Escalation means that the new drug is introduced in low doses, and gradually increased. If the first group of participants do not have many side effects, the second group will be given a larger dose, until the best results with the least side effects are achieved.
During phase 1 clinical trials, doctors also try to determine the most effective way to administer the new drug. For example, perhaps a drug works best when it is administer intravenously. Sometimes inhaling it, or taking it orally is the most effective solution.
Phase 1 clinical trials usually last several months to a year and involve a small group of a dozen or two participants. Many times, the patients who are willing to be the first human test subjects for a new drug do so because the medical condition they have has not improved their symptoms.
- Phase 2 Clinical Trials
Phase 2 clinical trials delve deeper into the safety of the drug treatment, and the effectiveness of it. This is also the phase in which doctors go into the specifics of the type of medical issue that is treated. For instance, if a medical treatment for cancer were being tested, it is during the phase 2 clinical trials that the particular type of tumor that it is effective for treating would be tested.
Phase 2 clinical trials typically last a lot longer than phase 1 and involve more people. The typical phase 2 clinical trial lasts about 3 years, and involves as little as 30 people, and up to several hundred.
A common approach to phase 2 clinical trials is a randomized testing method. Perhaps they’ll use a control group who goes through a conventional treatment for the medical issue, and then another group who uses the treatment going through clinical trial. Afterwards, the results of the two treatments are compared for effectiveness.
In order to progress to phase 3 clinical trials, doctors must establish that the medication is effective and at least as safe as conventional treatments.
- Phase 3 Clinical Trials
Phase 3 clinical trials are also randomized, but are designed to show whether or not the results from the medication being studied are better than conventional treatment plans. This might involve several different test groups that are given several different treatments.
The test groups are also much larger than in phase 2. Phase 3 clinical trials involve several hundred to several thousand participants. It is important for each randomized group in include a variety of patients of different ages, genders, and ethnicity, to ensure the data isn’t skewed if one subset has more of one demographic that respond better to the particular treatment than others (for example, younger patients might recover quicker because of their age and not the treatment).
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