There are 2 main types of studies:
In-Patient studies are conducted at a Clinical Research Facility. Studies will last between one and thirty nights or more. The study may have one period or there may be multiple stays. In order to participate in an In-Patient study, you must be available to stay at the facility without leaving for the entire duration of the stay and or stays. That means you are at there 24 hours a day! In addition to the In-Patient stay, you may also be required to come in for one or more Out-Patient visits. These visits usually pay between $50 to $100 and are factored into the payment.
Here is a chart to give you a good idea of what payments to expect for the amount of days spent in a study. These are broad and most clinics will be in the middle of the range. The payment depends on the amount and intensity of the procedures you will be required to complete during the study. This chart is based on total payment based on number of days spent in the clinic and any potential Out-Patient visits. This chart is for reference only as there is no standard for clinics to base their pay on.
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Out-Patient studies are consists of one or more visits to a Clinical Research Facility. Most visits last from one hour to three or four depending on the nature of the visit. While some healthy studies are done solely with Out-Patients, you will see far more patient studies done this way. Patient meaning people with the symptoms that the drug is meant to treat. Unfortunately, most Out-Patient studies will not pay nearly as much as In-Patient studies. Typical pay ranges from $50 to $200 per visit and depending on the study, you may receive a completion bonus after the study is done.
After you have determined whether you want to participate in an In-Patient or Out-Patient, you must decide what you want to test.
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This is the most common type of study you will see. You will take one or more doses during your stay or Out-Patient visits.
The first time a drug is given to human test subjects, it will more than likely be done as a "Double-Blind" Placebo controlled study. What this means is that not all of the test subjects will receive the study drug. If there are 10 subjects, 6 to 8 will receive the study drug and the remainder will receive a placebo, or inactive substance. "Double-Blind" means that neither you or any of the nurses or technicians will know who is getting the real drug and who is getting the placebo.
Some studies will be done as "open-label" which means that everyone will get the study drug. You will know exactly what you are getting. Typically these are late Phase 1 studies.
Some studies are "bio-equivalency" to compare a generic drug to the brand name drug. You will typically come in for two stays of equal length and take 1 drug during the first stay and the other drug during the second stay with a period in-between for "wash-out".
Multiple drugs may be tested at one time. You may take one drug for one period and then take another drug for a second period and then take both drugs during a third period. Or you might take one drug for a few days and then add a second drug.
As you can see there are many different dosing scenarios. Be sure to pay attention to the informed consent form. This will outline in detail the drug(s) you will be taking, how they will be administered, how much and when.
Drugs are administered in several ways. The most common are in pill, liquid (oral), skin patch, injection, suppository and intravenous infusion. |
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Mass Market Drug: These are drugs that are already on the market. Occasionally, studies are done with these drugs to study the effects of the drug with a certain variables like alcohol or diets. This is done to determine how something like alcohol or a certain diet affects the drug. |
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Radio-Label Drug: Some drugs are tested with a radioactive element which allows the drugs to appear better in blood, urine and stool collections. The radioactive element is carbon 14 and is given to you in a low dose, usually in a less dose than environmental radiation. The FDA regulates how much radiation can be administered to human test subjects. When you participate in a radio-label drug, you will take one or more doses of the drug without the radioactive element and then one dose with the radioactive element. On this day, you will have multiple blood draws (pk). At this point, you will stop dosing and start urine, stool and daily blood collection. Once the clinic has determined that the drug has been completely excreted from your system via blood, urine and stool, you will be released from the clinic. The amount of days you will spend in the clinic will depend on your body's metabolism. Each radioactive study is different. The amount of radiation you will receive will vary. |
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Medical Device: You will see many of these studies as Out-Patient visits. These can range from testing simple things like latex gloves to brain imaging scanners. |
The sponsor is the company that is requesting the drug trial. You will hear this term a lot while your signing up and doing a study. Don't get this confused with the company conducting the clinical study. For the most part, the sponsor is a pharmaceutical company that is developing an investigational drug. There are non pharmaceutical companies that sponsor trials as well. You'll see the majors like Pfizer, Glaxo-Smith-Kline, Bristol-Myers-Squibb, Astra Zeneca and so on. You also see smaller companies you've never heard of and everything in-between.
The sponsor makes all of the final decisions during the study. They can change or cancel the study at anytime, for any reason. The sponsors will not know who you are except by your medical information. Study participants are generally given a number or their initials are used as identifying information.
Every aspect of the study is predetermined by the sponsor. This includes the lab values for blood, diet consumed, visitation, whether or not subjects can go outside and many other conditions.
Representatives of the sponsor are usually present during the first dosing and may come in at various times throughout the study. They do not speak to subjects, only research staff. Due to confidentiality and for the validity of the study results, is not appropriate to carry on any conversation about the study with the sponsor unless they speak to you.
Some pharmaceutical companies such as Pfizer, Abbott and Bristol-Myers-Squibb (BMS) have their own "in-house" clinics but they still out-source a portion of their studies to research clinics.
This is the company that is conducting the clinical study for pharmaceutical companies. There are dozens of commercial companies in the US as well as around the world. Universities and hospitals also conduct clinical studies. Clinics carry out the study according to the needs of the pharmaceutical companies. Clinics are responsible for recruiting volunteers like you to participate in studies. Clinics provide accommodations during the studies. Accommodations vary from clinic to clinic but will generally include a place for you to sleep, recreation (games and entertainment, not workout stuff!) and dining area. The clinics will provide meals according to the requirements of the study.
The Food And Drug Administration closely monitors drug studies and must approve phase of the study. The FDA also has the power to intervene with a study if they feel there is a safety concern. This may be as simple as modifying the protocol to include more testing results or more severe as in postponing or even canceling a study. Ultimately, it is the FDA who will decide whether a drug is safe for the public or not.
Every Clinical Research Facility is required to use an Institutional Review Board. The purpose of the IRB is to protect you, the volunteer. They approve every aspect of the clinical studies based on how the patient will be treated and according to the FDA Human Subjects regulations. If you have any concerns about the study or clinic, you are allowed and encouraged to contact the IRB. Contact information will be with the Informed Consent.
This is the first thing you will see when you arrive at a Clinical Research Facility. Read this carefully! It will disclose everything you need to know about the drug(s) you will be testing and any possible or known side-effects which you may experience. It is important to note that some or all side-effects may not be known due to the fact that few if any humans have tried the drug. This form will describe how the drug will be administered, how many times and what time of the day.
When you sign the form, you are giving the company permission to administer the study as they seem fit, which is always going to be in the best interest of your health and welfare.
Feel free to ask any questions you may have about the study. The recruiter will answer them the best that they can and usually can get the answer if they don't have it.
You may withdraw your consent at any time for any reason. This does of course mean, that you will not be able to complete the study and may receive a reduced compensation.
Compensation will vary from study to study. For the most part, compensation is based on the amount of procedures you will be subjected to and the length of stay. This includes blood draws, ECG's, 24-Hour Heart Monitoring, urine/stool collection, vitals and any other procedures that is necessary for the study. Compensation is also determined based on the risk factor of the drug. Investigational studies will pay more than bio-equivalency studies as the risk of an investigational drug is greater than a drug that has been on the market for years.
You will be informed up front of how much you'll be compensated based on completing the entire study. If you leave early on your own accord, you will typically receive a pro-rated amount based on the amount of time to spent at the clinic. In the event that you have adverse side-effects and the study doctor dismisses you, you will typically receive the entire compensation for the study, though this policy varies from clinic to clinic.
This is the most common question people have.
Is it safe to participate in a clinical study?
The answer is yes and no.
You will be taking an experimental drug that few or no humans have taken before. So, yes. There is a chance that you may become ill, have adverse side-effects or possibly die. But the risks can be greatly reduced if you are honest when signing up for a study. Don't lie about your medical history! Your only going to increase the risks. Also, you must follow all the directions that the clinic gives you. Failure to follow the directions will increase your likelihood of having complications.
The clinical research facility will minimize the risks by informing you about the drug, the intended use, the known side-effects as exhibited in lab animals and any other information they have. They will also have qualified medical staff on hand in case something does go wrong. The clinic is obligated to pay for any medical treatment due to a adverse affect as long as you have followed all of the study procedures. Examples: You experience rashes from taking a medication. The clinic will likely have you see a dermatologist or may even bring one in. any medication necessary to heal your skin will be provided. Let's say you decided to sneak in some cough medicine and this in combination with the study medication cause you to become ill. More than likely, the blood work will show an unknown substance and you will be kicked out of the study with a bill for any medical treatment rendered. So, it's very important not to do anything that is strictly prohibited in the informed consent form.
It should be emphasized that making a decision to participate in a research study is serious and can have ramifications even when the study is conducted properly.
It is up to you to be honest, responsible and ethical when participating in clinical research studies.
In the end, the only way to eliminate the risk of doing a clinical study is NOT TO PARTICIPATE!
Whether you have bad reactions to a drug or not, your results are a vital part to the development of drugs that can help improve the lives of millions of people.
Discovering possible side effects is a vital process of clinical research. Many drugs can be used for multiple conditions based on the side effects. A popular male erectile dysfunction drug was redeveloped from a drug originally designed for high blood pressure.
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Updated on 9/5/08
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