Clinical Studies Defined
A clinical study (sometimes called a clinical research study, trial or protocol) is a way to determine if new medications are safe and effective. Medications being researched for safety and effectiveness are known as investigational drugs or study drugs.
Types of Clinical Studies
There are four types of clinical studies:
Phase I studies test a new investigational drug on humans for the first time, using a small number of volunteers to study best dosage and potential side effects.
Phase II studies test an investigational drug with a larger number of volunteers to learn more about side effects, how the body uses the drug, and how the drug helps the condition.
Phase III and IV studies use larger numbers of volunteers and may compare the investigational drug with a commonly used drug or a placebo (an inactive substance).
Clinical Study Participants
People who take part in clinical studies include:
Children and adults wishing to improve their own health. They may be patients with newly diagnosed medical problems. They may have had the problems over a period of time, or they may have a family history of a certain disease.
Healthy volunteers who seek to advance knowledge about causes, progress and treatment of disease also can participate in clinical research. They provide important medical information to researchers by helping them compare how healthy people differ in their response to an investigational treatment from those who have a specific disease.
Study participants must meet certain requirements, which are different for each study.
Costs of Clinical Study Participation
You do not pay a fee for study participation. In some circumstances, you may even qualify for financial assistance or reimbursement for travel and other expenses.
Your Rights as a Clinical Study Participant
An Institutional Review Board (IRB) approves and monitors all clinical trials to help ensure that the rights of participants are protected.
Informed consent is a process that educates potential study participants on all the key facts about a research study to help them decide whether study participation is in their best interest. Informed consent continues throughout the course of the study to keep participants abreast of important information. Study enrollment is not binding and participants may withdraw at any time.
Potential Benefits of Clinical Study Participation
- You play an active role by choosing standard healthcare or research.
- You will receive study-related medical care during the trial.
- The study medication, tests and exams are provided to you at no cost.
- You may help others in the future by contributing to medical research today.
Potential Risks of Clinical Study Participation
- The study treatment may not improve your condition.
- You may experience side effects.
- Your study doctor will discuss with you any other potential risks.
Before You Decide to Participate in a Clinical Study
To help you determine whether study participation is in your best interest, here are a few questions you may want to ask your personal physician:
About Your Condition…
- What caused my condition?
- How will this condition affect my health now and in the future?
- Should I watch for any particular symptoms and notify you if they occur?
- Is it possible to any lifestyle changes to lessen the progression of my condition?
About Study Medication…
- Why do researchers believe the study medication may be effective?
- What are the risks and side effects associated with the study medication?
- Has the study medication been used in human subjects previously? If so, what were the effects?
- How does the study medication differ from standard medications?
- Are there foods, drugs or activities I should avoid while I’m on the study medication?
- What should I do if I miss a dose of study medication?
About Your Study Tests…
- What do you expect to find out from these tests?
- When will I know the results?
- Do I have to do anything special to prepare for any of the tests?
- Do these tests have any side effects or risks?