Whenever clinical drug development or medical research studies need to be done, all drugs, interventions, and treatments have to go through a clinical study or clinical trial. Clinical drug development trials generally have four stages, labeled I-IV. Each phase has a different purpose, and each phase is critically important to establishing if a drug or treatment is better than existing treatments. A typical clinical trial in 1999 lasted for 460 days. Today, they last nearly twice as long. This is to ensure the safety of all treatments and drugs.
When asked, 46% of people agree that taking part in clinical drug development is as valuable a contribution to healthcare as donating blood. But when someone is asked to take part in a clinical trial, they are not just asked so that drugs can be trialed, but so they can also be helped as well. The American Psychological Association’s Ethical Code demands clear informed consent for anyone taking part in medical research studies. If you or someone you love has the opportunity to take part in clinical drug development, it can be helpful to understand the different phases and what is happening in each.
Phase I Trials
During a phase 1 clinical trial researchers are testing a drug for the first time. The purpose of this phase to decide if the drug is safe and if it has any unanticipated side effects. It’s also important to decide the best way to administer a new drug. These trials usually use small groups of people to do testing.
Phase II Trails
During the second phase of clinical drug development, more people take part: usually between 100 and 300 people. This phase determines if a drug works in the way it’s supposed to be working, and there are further evaluations of possible side effects.
Phase III Trials
In this stage, large groups of people take part to confirm that a drug is effective and safe. Both the effectiveness of the treatment or drug and its side effects will be compared with any standard treatments already being used. During this phase, researchers also collect more information about the safest and most effective way to use the drug.
After the third phase of clinical drug development, all the information is sent to the FDA for evaluation. If they determine the treatment is safe and effective, it will be made available to all patients. Currently, an average of 5,000 to 10,000 drugs enter testing every year, but only five of those will make it to clinical trials. Of those five, only one is typically approved in a year.
Phase IV Trials
This trial involves many people and is conducted after FDA approval. Its main purpose is simply to watch carefully for any longer-term side effects that may have been missed in previous trials.
Clinical drug development is crucial to responsible health care, advancing world health, and finding the cure for our worst diseases and disorders. Without the clinical study, most of the best treatments we already have would not be available. Scientists, doctors, researchers, volunteers, and the government will continue to cooperate into the future to make sure that medical research studies go forward and help us all.