About Clinical Research
Different Types Of Studies:
For the very first dosing to humans (First In Man), typically, there will be about 5 to 6 groups of people dosed at escalating levels. Example: The lowest dose may be a fraction of the highest dose given to a lab rat (animal). The second and each additional dose will be tripled, until reaching a dose that is beyond what a human would normally take. Typically, each group will consist of 6 to 10 people depending on the objectives of the study. Most times, studies involving the first human does will be single doses and will last 2 to 4 days.
Once the initial doses have been completed, longer studies are conducted. These studies may last from several days to several weeks with the subjects taking the drugs every day. Most times drugs are administered for periods of 1, 3, 5, 7, 10, 14, 18, 21, 24 or 28 days. You may see some other variations depending on the type of drug and the objectives of the study.
Study drugs may be taken in combination with marketed drugs to see how one affects the other. This may be done in several ways but the most prevalent protocol is 3 periods which may have a wash out period in between, sometimes not. You may take one drug for 7 amount of days, then have 7 days off, then take the other drug for 7 days, another 7 days off, then you take both drugs together for 7 days. This is not to be confused with bioequivalence studies. In these studies, a generic version of a marketed drug is tested to make sure it performs the same ways as the original. You’ll take one drug for one period and then the other for the second period.
Drugs may be administered in several ways. The most common ways include pill, liquid, intravenous, skin patch, injection and suppository.
Many studies will include the use of placebos or non-acting substances. The purpose of giving a portion of the volunteers placebos is to create a benchmark or control. This is done for many reasons but the most important reason is to help ensure that research subjects are reporting adverse effects.
Contrary to popular belief, you will know what drug you are taking (with the exception of a blind study where some people receive a placebo). It’s not a mystery concoction they hand you. The clinic will provide as mush information as they have available about the study medications.