With increased pressure on medical research studies to develop and implement new drugs, the amount of clinical trials performed ever year continues to increase. Although only a very small number of clinical trials result in the widespread distribution of a new medication, there are millions of investors hoping that they pick the right biotechnology startups. Clinical trials are comprised of four parts, and as new medications pass each section of review, the chances of the project coming to fruition increase.
The first step of clinical trials is referred to as Phase I or a Phase 1 clinical trial, and research teams administer an experimental medication to about 75 people. They are trying to evaluate the medication for safety and side effects. Of course, many drugs that make it to market have a list of side effects, but consumers should know that those side effects are usually rare and are confined to a small sub-section of the testing populace. Once a drug passes Phase I, it moves on to Phase II, where it is given to a larger trial group of about 300 people for a clinical study. Researchers are still investigating side effects, and one of the down sides of medical trials is that it is difficult to study the long-term effects of a particular medication before it is approved. There are millions of consumers who are taking psychiatric medication, for example, and the long-term effects are, as yet, unknown.
Phase III trials test new medications’ safety and side effects, and medications are given to more than 3,000 people for testing at this phase. Researchers are attempting to see whether their medication is more effective than its competitors and whether there are any serious side effects that become apparent once the control group is larger. Recent attempts to develop a male contraceptive largely failed when study groups reported high levels of depression and anxiety. Since there are many varieties of female contraceptives that are available, the push to deliver a male version is less urgent than with other medications. Cancer and diabetes treatments continue to be high priority for American clinical drug development firms.
In the final stage of clinical drug development, referred to as Phase IV, researchers are allowed to submit an application for approval for widespread distribution of their medicine. Surprisingly, there are more than 10,000 new medications that undergo the process of clinical drug development each year. Only five will pass the first three phases, and only one out of every 10,000 new medications will be approved by the FDA. It is essential to rigorously monitor new drugs before they are approved, and biotech investors have no guarantee that the medicines and treatments they invest in will make it through all stages of clinical drug development and then to the pharmaceutical marketplace.
Nowadays, clinical trials last longer and more effort is put into awareness of potential side effects. If you take a medication, it has been approved by the FDA. There remains a high percentage of counterfeit medications that are distributed around the world, but newer tracking technology is working to combat the criminals who manufacture and distribute fake medication. The dangers of taking a drug that has not been approved and vetted by the FDA are serious: people should only obtain medications from their local pharmacies. Drug development is big business, but there are safeguards in place that allow developers the time to test medications before they are widely used.
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