A clinical trial is a research study involving a select group of people who have volunteered to try an intervention — such as a drug, device, vaccine, or other therapy or procedure — under close medical monitoring.
Each clinical trial is carefully designed by medical scientists to give the most information about how a drug works using different doses under different conditions and in different groups of people. The design of the trial is outlined in a “protocol.”
All subjects are carefully selected, and each gives his/her informed consent to participate in the clinical trial.
The study answers researchers’ questions about the safety and/or effectiveness of the intervention. Before reaching the clinical trial stage, new interventions typically have been studied in the laboratory (in nonclinical studies) and in animals (in preclinical studies).
Below are frequently asked questions about clinical trials and observational studies. To learn about specific studies that are enrolling at Rainier Clinical Research Center, visit Current Studies, where you can view all our enrolling studies.
Clinical trials for treatments and vaccines typically have four phases, each of which is designed to answer different research questions. The phases are:
If an intervention is successful in one phase, it may move on to the next phase. Each successive phase typically has a greater number of participants. Sometimes two phases are combined. In a Phase 3 study, each participant is randomly assigned to one of two groups. Only one group will receive the new intervention being studied; the other will receive the standard treatment for that disease.
Every effort is made to ensure the participant’s safety during the study. The ethics and laws that govern medical practice also apply to clinical trials. Clinical trials come with certain risks. New interventions being studied in a clinical trial may or may not be as effective or safe as standard treatments and care. Indeed, in early clinical studies, the safety, side effects and effectiveness of the intervention are still being ascertained. In randomized studies, patients cannot choose which group they are assigned to; in blinded studies, patients do not know which intervention they are receiving (or, in some cases, whether they are receiving a placebo).
Many measures are taken to protect the safety of clinical trial participants, including careful study design, oversight by institutional review boards and periodic monitoring of study data by independent experts. Participants also receive close medical attention and observation. Researchers must inform participants of any new risks, benefits or side effects they discover.
Participation in a clinical trial may involve diagnostic tests, treatments, procedures, doctor visits or hospital stays that are not part of standard care. Preventive studies may involve making changes to diet, exercise, or other aspects of lifestyle. Some observational studies involve minimal effort, such as agreeing to share certain test results, maintaining a diet or exercise log, or filling out questionnaires.
Placebos, which do not contain any known active ingredient, may be used in clinical trials, but not if it would mean putting participants at risk by denying them effective therapy. This is particularly true for cancer and other serious illnesses, where placebos are rarely used. You can find out in advance if a study you are considering might involve a placebo.
Costs for studies at the Rainier Clinical Research Center are covered in full, and there is no association with the participant’s health insurance. You can ask the study staff to explain how costs work. Most of our studies also provide the participants with a stipend for participation.
The descriptions of clinical trials clearly spell out who is potentially eligible. Criteria may include age, gender, ethnicity, type and stage of disease, or other characteristics. Many studies also spell out medical conditions that may exclude a person from eligibility. The recruitment coordinators can review eligibility with you to see if you are qualified to participate in our studies.
Each study will specify how to enroll — such as by contacting the recruitment coordinators or researchers via telephone, email or filling out an online form.
The recruitment coordinators and researchers will review each person’s information to determine eligibility and may ask prospective participants to come in for a screening visit or take part in a phone interview.
Yes, most trials offer compensation. Typical studies at the Rainier Clinical Research Center pay anywhere from $75 to $4,500. This will be spelled out clearly in the study description. Compensation depends on the number of clinic visits and the duration of the study.
A study participant can withdraw from a clinical trial for any reason and at any time. The study team may ask to continue monitoring that person for a period of time to assess any long-term effects of the treatment received in the study.
- Brittany, study participant