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Anamarie Smith
General Manager
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Emcee Park
General Manager
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Anamarie Smith
General Manager
A clinical trial is a type of research that studies a test or treatment given to humans. Clinical trials study how safe and helpful tests and treatments are. When found to be safe and helpful, they may become tomorrow’s standard of care. Clinical trials can study many things, such as:
Clinical trials are carefully designed, reviewed, and completed. The principal investigator is the person in charge of the trial. He or she is a doctor or scientist who is an expert in what the clinical trial is about. The principal investigator takes the lead in designing the clinical trial, choosing the research team, and carrying out the study. Often, other medical staff, called investigators, are part of the research team.
Clinical trials need to be approved before they can start. Clinical trials need sponsors since they can’t be done without money or other support. Sponsors often are government agencies, pharmaceutical (drug) companies, and non-profit organizations. Sponsors of the clinical trial review the research plan (also called protocol). Funding or other support is given by the sponsor once the research plan is approved.
Clinical trials also need approval from an IRB (Institutional Review Board). An IRB is a group of people chosen by the health care center where patients will be enrolled into a clinical trial. Each IRB include five members. These members must include a scientist or someone in the medical field, someone who’s not a scientist, and someone who’s not from the health care industry. The IRB reviews the research plan to make sure the rights and welfare of patients are protected. After the trial has started, the IRB reviews its progress at least every year.
What each clinical trial has to offer to patients differs. However, there are four general benefits. First, you'll have access to the most current cancer care. Second, you will be treated by experts. Third, the results of your treatment—both good and bad—are carefully tracked. Fourth, you may help other patients with the same disease.
Prior to the clinical trial conduct, the protocol and other pertinent study documents must be reviewed and approved by the regulatory authority and ethics committee. It is your right to ask and verify with the respective clinical trial doctor or staff if the clinical trial has received all necessary approvals prior to its patient recruitment and conduct.
As a clinical trial participant you have the right to be informed about the clinical trial information such as but not limited to the following
The above information and other information related to the clinical trial protocol and its conduct should be done through proper Informed Consent Process wherein you should be given ample time to read the Informed consent form and to understand its content fully through discussion with the delegated clinical trial investigators. The discussion must be conducted in a private manner and you should be given enough time to ask questions until you have complete understanding about the trial. You must be given enough time to decide with regards to participating in the study. Your consent to participate must be documented by signing the informed consent form by you and the delegated study doctor or staff. You should be given a copy of the informed consent form that you have signed.
As a clinical trial participant your safety and rights must always be uphold during your entire participation in the study. There is an independent body that is responsible in monitoring and ensuring that your rights and safety are uphold throughout the study participation.
