Screening For Participation
The earlier section discussed how Clinical Trials have protocols or study plans that describe what will be done in the study and how the study will be conducted. They are designed to safeguard the health of the participant as well as answer specific research questions.
To take part in a clinical trial there are specific criteria that must be met for participation. To ensure that all possible side effects as well as benefits of the drugs or treatments being proposed are thoroughly examined, study criteria must be adjusted.
Guidelines are developed by researchers to determine who can participate in a clinical trial. Some trials require participants to have specific medical conditions and some trials require healthy participants with no disease.
Guidelines that allow participation in a clinical trial are called "inclusion criteria" and those that disallow participation are called "exclusion criteria." It is important to choose participants who meet the requirements for the trial to establish adequate and reliable results.
How will I know if I am eligible to participate in a clinical trial?
Each clinical trial has eligibility criteria, which are requirements that patients must meet before they can participate. Eligibility criteria might include information about:
- Age and gender
- Type of cancer
- Stage (extent) of the cancer
- Previous treatments that you must, or must not, have had
- Length of time since you last received treatment
- Results of certain laboratory tests
- Medicines that you are taking
- Other medical conditions
- Previous history of any other cancer
- Other conditions that are specific to each clinical trial3
If you have found a clinical trial, you might qualify for, talk to your doctor, or contact the clinical trial's principal investigator or research nurse. A member of the study team will ask you questions about your medical history to see if you meet the study's eligibility criteria. These criteria are not used to reject potential participants, but rather to ensure safety. In addition, utilizing these criteria ensures the information obtained will answer the researcher’s questions.
The Research team consisting of doctors and nurses will explain the trials' purpose, procedures, risks and benefits. Informed consent must be obtained before you can participate in a clinical trial. This process allows potential participants to obtain all the facts on the study and make a well educated decision on whether to take part in the trial. The research team will provide you with an informed consent document that includes details of the study, purpose of the trial, duration or length of time the trial will run, and required testing such as lab work, scans and key contacts. Also included in the informed consent is an explanation of potential risks and benefits of the trial. Once informed, you may decide whether to accept or decline participation in the trial. Informed consent is not a contract. You have the right to leave the study at any time. By signing the consent you are not obligated to participate, you can always change your mind. If you choose to leave the study, your doctor will discuss other treatment options.
Understanding your rights through a clinical trial is important. You have the following rights:
- To understand all of your treatment options
- To know what is involved in the trial such as tests, risks and benefits
- To have the opportunity to discuss the trial with the investigator and research team
- To hear and read information in a language you can understand
- Having access to promising new treatment approaches that are often not available outside a clinical trial setting.
- The approach being studied may be more effective than the standard approach.
- Receiving regular and careful medical attention from a research team that includes doctors and other health professionals.
- Being the first to benefit from the new method under study.
- Results from the study may help others in the future.
- New drugs or procedures under study are not always better than the standard care to which they are being compared.
- New treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.
- Participants in randomized trials will not be able to choose the approach they receive.
- Health insurance and managed care providers may not cover all patient care costs in a study.
- Participants may be required to make more visits to the doctor than they would if they were not in the clinical trial.4
3Frequently asked questions about clinical trials. Retrieved 3/24/2009 from
4Clinical Trial Benefits and Risks. Retrieved 3/30/2009
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