An Overview of the Clinical Drug Development Process

An Overview of the Clinical Drug Development Process

Health and Fitness March 23, 2017

Clinical study

Did you know that before a drug gets the go-ahead to be prescribed to patients by doctors, it goes through over fifteen years of medical research studies and costs an outrageous $2.6 billion? This might seem excessive, but the rigorous research and testing standards are in place to protect you.

Because of the testing standards that the Federal Drug Administration (FDA) has, you can have access to all of the information related to the side effects and risks that you’re taking when you take a medication. If you weren’t given this assurance, you might not have faith in the medical system, and might feel inclined to forgo medical treatments that you really need.

Other benefits of the FDA drug approval process include verifying that the medication does what it claims it does, establishing a shelf life in which it can be safely taken, and identifying conditions that compromise the effectiveness or safety of the medication.

So how does clinical drug development really work? We’re glad you asked. We’ve outlined the typical clinical study process below:

  1. Phase 1 Clinical Trials

    By the time a drug makes it to phase 1 clinical trials, it has already gone through the testing that can be accomplished without human involvement. This includes testing in a test tube and testing on animals. It has established that there is merit to the medical treatment, and human subjects are needed to study how the human body reacts with it.

    Phase 1 clinical trials utilize the smallest test group (usually less than three dozen people) and last anywhere from a few months to a year. One of the main questions that are answered during phase 1 clinical trials include the dosage that provides the greatest results, with the least amount of side effects. Other important information gathered in this phase include how the human body processes and utilizes the medication, since this is the first exposure to humans.

    Since there are so many unknowns at this point in the testing process, the subjects who participate in phase 1 clinical trials are taking the greatest risk. This is often worth it for them because they’ve exhausted all other medical treatments without getting the results they had hoped for. Additionally, many phase 1 clinical trials compensate their patients up to $2,000 for participating.

  2. Phase 2 Clinical Trials

    During phase 2 clinical trials, researchers analyze the safety of the medical treatment in question, and the effectiveness of it. In order to establish that the treatment is as effective or better than the standard treatments used for the same condition, doctors will conduct a randomized study. This means they’ll give several hundred patients either the treatment being tested, or one of a few conventional treatments. The effectiveness of the treatment in question is compared to the results that the other treatments achieved.

    This phase of testing lasts several years and involves as little as 30 patients and as many as several hundred patients. The drug must be proven to be as safe as conventional treatments and equal or better in effectiveness in order to move to the next phase.

  3. Phase 3 Clinical Trials
    The final round of testing is phase 3. If a drug makes it to phase 3 clinical trial, it means that it has shown itself to be effective for treating the condition it is meant to treat on a small scale. The point of phase 3 clinical testing is to gauge the effectiveness of the medication on a grand scale, for a longer range of time. While the previous phases are too narrow to include factors that could alter the results, such as age, gender, and ethnicity, phase 3 testing is broad enough to include these factors.

    As you can imagine, this phase of testing is the largest and longest phase in the drug development process. Phase 3 clinical trials often take several years to accomplish, and involve thousands of people. Since the patients who participate in phase 3 testing are taking a relatively lower risk by participating in the study, they usually are not compensated for their participation, but have access to an otherwise unavailable treatment for free, often at renown medical facilities.

Do you have questions? Please share in the comment section below!