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. 

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. 

For the very first dosing to humans (First In Man), typically, there will be about 5 to 6 groups of people dosed at different 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.

Clinical Research Facilities are contracted by Pharmaceutical companies to test new investigational drugs.  The Clinics conduct studies according to the objectives of the company sponsoring the study.  The Clinic will recruit the necessary volunteers based on criteria outlined by the sponsor.  Once a panel of qualified volunteers are selected, the Clinic will carry out the study and then report it's findings to the sponsor.  These types of clinics are also known as Contract Research Organizations. 

While most studies are conducted by contracted Clinical Research Facilities, some Pharmaceutical companies have their own in house Clinical Research Facility where a portion of the studies are done.  Many Universities conduct Clinical Research Studies as well as hospitals.  Studies conducted by hospitals and Universities are generally out-patient and pay less than a contracted company.   

Volunteers are needed to test these new drugs!  Healthy volunteers are always needed!  For a few hours, days or weeks of your time, you can help make it possible for new drugs to reach the market.  Patient volunteers are always needed too!  Imagine participating in a study that may help improve your condition while getting some compensation at the same time.  The amount of time required will vary from study to study.  Some studies are out-patient and take up a few hours per visit.  Other studies require you to stay overnight at a clinic for one or more nights. 

When you participate in a study, you are volunteering to be there.  You may quit at any time for any reason.  If you feel that your health is at risk or your just not comfortable with being in the study, you can withdraw your consent at anytime.  Be aware that if you do quit early, your payment will be reduced.  You will only be paid for the time spent in the clinic. 

Wonder what you can expect to do all day?  Check out a sample schedule!

This is where the rubber meets the road.  Patient volunteers make up the bulk up the volunteers who test potential drugs.  Once the drug is deemed safe in a healthy person and known side-effects are discovered, the drug is tested for proof of concept.  People who have the disease or condition that the drug has been developed for are needed to see if the drug actually works.  Most of the early patient studies, late Phase I, will be done in-house at a clinic with subjects staying 1 or more nights.  These studies will pay relative to healthy in-house studies.  Most of the Phase II and III studies will be done as out-patient visits.  Commercial clinics, hospitals and community clinics will conducts these studies.  The pay will be significantly less as the main benefit of participating in a patient study is the possibility of better ways to manage or treat your condition. 

While this site is primarily geared towards healthy studies, there are some of the major patient clinics listed here. 

Volunteers come from all walks of life.  You have people who are in between jobs.  You have college students who do weekend studies during the year and long studies during breaks and over summer.  You have people who do studies full time, like a job.  You have people who do just one study.  You have people doing their 20th study.  Every study is an amazing melting pot of people from all over the country with backgrounds from former bus drivers to film makers.  Speaking of film makers, it is a well known fact that Robert Rodriguez partially funded his first film with money earned from clinical research.  And I used to be a bus driver.  Haha!  But seriously.  You never know who you might run into at a study.  And yes, I really was a city bus driver.