About Clinical Research
What is Clinical Research?
Before any new prescription drug reaches the market, the drug must first undergo dozens of successful Clinical Research Studies to prove it’s safety, tolerability and effectiveness. Long before any human will test a drug, rats and other animals are used extensively to assess the drug. Once the drug studies in animals are completed, the long process of Human Clinical Research Studies will begin. On average, only 1 in every 10 drugs that start human research trials will ever reach the consumer market. Also, bringing a new drug to market does not happen overnight. From concept to approval by the FDA to your medicine cabinet may take 7 to 10 years at a cost of several hundred million dollars or more.
Below is a typical life cycle of a Clinical Research Study. This is not to be viewed as the way all studies are done, but just as an example.
|Wikipedia||Phase I||Phase IIa||Phase IIb||Phase III||Phase IV|
|Type of Subjects:||Normal Healthy||Patients||Patients||Patients||Patients|
|Number Tested:||20 - 100||25 - 75||50 - 200||300 +||1,000 +|
|Value of Study:||Kinetics|
|Proof of Concept||Confirm mechanism of action||Confirm Effectiveness||Market Expansion for new uses|
|Time Frame:||1 - 1.5 years||1 year||1 - 1.5 years||3 - 6 years||1 - 2 years|
After each study, the drug must be cleared by the FDA to continue to the next step. Between Phase III and IV, there is typically a 1 to 2 years delay for FDA approval. The drug will typically be marketed once this approval is granted and Phase IV is used for assessing long term effects and for finding additional uses for the drug.
People who participate in Phase I studies are generally healthy, normal people who do not have the disease or condition that the drug is being developed to treat. The purpose of Phase I studies is to determine how long it takes the medication to enter and leave the body. At this time, side effects are recorded and the maximum dosage amounts are determined. This is also known as Pharmakinetics (PK). Many drug companies are also studying genotyping, understanding why a particular drug affects different people in different ways. Again, with Phase I, the volunteers are not seeing if the drug works, just how it passes through and affects the body.