When experimental drugs and treatments are presented for the first time, they must go through clinical trials to determine whether they are beneficial towards humans, or whether they have any averse side effects. Medical research studies and clinical studies are important because they can help researchers determine the effectiveness of a drug and treatment before it is used en masse. 46% of people and researchers agree that its benefits are valuable to the health care system, sometimes making it as important as giving blood, as it can provide future treatment options for diseases currently either untreated or not treated effectively.
If you are interested in becoming involved in medical research studies and clinical trials — of which 96% of people state they have never participated in before, you should know a bit about how the trial will unfold over time. Here’s what you should expect for a timeline towards clinical drug development:
Phase 1 Clinical Trial
In phase 1 of medical research studies, researchers will test experimental drugs and treatment methods on a relatively small group of people, usually ranging from 20-80 people. This will be the first time the drug and/or treatment has been given to people, used to evidently determine the safety of the medication and whether or not it has any side effects.
Phase 2 Clinical Trial
During the second phase of medical research studies, the drug/treatment will be administered once again, this time to a much larger group (ranging from 100 to 300 people). This will be done once again to determine how safe a drug/treatment is, along with the effectiveness of it on said condition. Further side effects will be determined, as well as the likelihood of ones found prior.
Phase 3 Clinical Trial
This stage of the clinical study will see the drug or treatment being administered to even more people, now being given to nearly 1,000 to 3,000 people. The effectiveness of the drug will be further confirmed, side effects will be monitored from start to finish, and the methods of treatment will be compared to similar forms of treatment. All of this information will be used to determine the overall safety of the drug for modern use.
Phase 4 Clinical Trial
Following this phase, this is when the clinical team will submit a New Drug Application (NDA) to determine if it is approved for the market. It is during this time that it will be determined whether the drug will go on to pre-clinical testing. The likelihood of such testing will be low, considering that out of the nearly 10,000 drugs submitting a NDA per year only 1 is approved by the FDA for consumer use.