Understanding Clinical Trials
- What are Clinical Trials and Why are They Important?
- How are Clinical Trials Planned, Approved and Conducted?
- What are the Different Types (Phases) of Clinical Trials?
- What are the Benefits and Risks of Participating in Clinical Trials?
- What Should Patients Know Before Entering a Clinical Trial?
Depending on the type and purpose of the trial, the benefits and risks vary significantly. The following table summarizes possible benefits and risks that patients should carefully consider before enrolling in a clinical trial.
|Possible Benefits of Trials||Possible Risks of Trials|
Patients interested in participating in clinical trials should ask their physicians to thoroughly explain the trial, including its risks and benefits. Patients should learn:
- The purpose of the trial
- How many people will participate
- What type of tests and treatments patients must undergo
- How long the trial will last
- The potential side effects of tests or treatments
- What type of long-term follow-up care is provided
- Whether patients will have to cover any costs of the trial. If so, whether the patientâ€™s insurance cover the costs or if financial aid is available
The following terms may be helpful to patients who are considering participating in clinical trials:
|Protocol||The planned course of action for the clinical trial. The protocol is established prior to the start of the trial and states the number of participants, eligibility requirements, agents that will be used, dosages, duration, how data is collected, etc.|
|Investigator||A researcher in a clinical trial.|
|Sponsor||The party or parties responsible for funding the clinical trial.|
|Institutional Review Board (IRB)||An independent board of scientists, physicians, and nurses who review the clinical trial protocol to ensure patient safety.|
|Informed consent||A patientâ€™s decision to participate in the clinical trial after being informed of the potential benefits and risks of participation. Participants may withdraw their consent at any time and leave the trial.|
|Double blind||Term used to describe a clinical trial in which neither the patient nor the researcher knows which agents are being administered to which patients. This helps prevent bias.|
|Intervention group||The group of participants receiving the new preventive or treatment agent that is being evaluated in the clinical trial.|
|Control group||The group of participants receiving a standard treatment or placebo (see below) that is being compared to the new agent in the clinical trial.|
|Randomization||Assigning participants by chance to either the intervention group or the control group. Randomization is often done with a computer.|
|Placebo||An inactive substance that may be given to participants in a clinical trial. Sometimes called a sugar pill.|
|Follow-up||Monitoring of participants for a specified time after the clinical trial is completed.|
|Prospective study||A study of a group of patients that is conducted as they are undergoing a treatment or preventive measure.|
|Retrospective study||A study of a group of patients after they have already undergone a treatment or preventive measure. "Recall bias," unintentional inaccurate reporting of certain information, can sometimes influence a retrospective study.|
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Updated: August 2010