What is a Clinical Trial?
Clinical trials are studies that evaluate the safety and effectiveness of drugs, medical devices or other medical treatments when tested on human beings. Clinical trials follow a defined study plan known as a protocol. Clinical trials are conducted by medical personnel, such as doctors and nurses. Doctors who conduct clinical trials are also called investigators.
What happens during a clinical trial?
What happens in a clinical trial depends on the trial itself. In some clinical trials, there may be more tests and trial-related visits than you would normally have for a particular illness or medical condition. As a qualified volunteer for a study you will receive all medical visits related to the study at no cost. These can include: physical exams, doctor visits, study medications, laboratory tests, EKG’s, etc. These additional medical test and clinic visits help site staff monitor your general health and safety throughout the trial carefully.
Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
- In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II clinical trials, the study drug or treatment is given to a larger group of people (40-100) to see if it is effective and to further evaluate its safety.
- In Phase III studies, the study drug or treatment is given to large groups of people (more than 200) to further determine its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- In Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
Patients’ rights & patient safety
The protection of your safety and rights are essential to conducting a clinical trial. The Institutional Review Board (IRB) must grant approval to any doctor conducting a clinical trial. They also examine all study protocols to ensure patients’ rights are protected and that the research studies in no way presents an undue risk.
Clinical trials are conducted according to strict scientific and ethical principles. The same ethical and legal codes that govern medical practice apply to clinical trials. It is important that volunteers are well-informed and feel confident and secure about participating in clinical trials.
Can I continue to work with my primary health care provider while in a clinical trial?
Yes, most clinical trials provide short-term treatments related to a designated illness or medical condition, but do not provide extended or complete primary health care. In addition, by having your primary health care provider work with the site staff, you can help ensure that other medications or medical treatments will not conflict with the protocol.
What should I know before participating in a clinical trial?
The investigator or clinical research coordinator will provide you with detailed information about the trial to allow you to decide whether or not to participate. The process of understanding the risks and benefits of a trial is known as informed consent. The doctor will continue to keep you informed throughout the trial and will provide you up-to-date information.
The investigator will provide an informed consent document that includes details about the study, such as:
- Purpose of the research
- Trial duration / how long it lasts
- Details about the investigational treatment
- Medical tests and procedures required by the trial
- Key trial contacts
- Risks of participation
- Potential benefits of participation
You should know as much as you can about the trial and feel free comfortable asking your doctor any questions you may have related to the trial. Once you are comfortable with your understanding of what’s involved, you will have the opportunity to decide whether or not to sign the informed consent document, stating that you are willing to participate. However, keep in mind that the informed consent document is not a contract and you may withdrawal from the clinical trial at any time and for any reason.
What are your responsibilities?
Once you sign the Informed Consent form, you will be given the study drug and the placebo. It is important that you keep taking both medications each day. If you don’t take both drugs then we won’t know if the drug is working. You need to take it with your other prescribed medications. Also it is your responsibility to attend all follow up visits. That way, we can keep track of how you’re doing. You can also use this time to get any answers to any questions you may have.
Reasons to participate:
A new drug must be tested extensively prior to being made available to the public. Most of our current information on medications on the market and disease have been obtained from clinical research studies. New drugs are being developed daily and may offer advantages over existing ones. There are many reasons why people volunteer to participate in clinical trials, including:
- Opportunity to help those who suffer from medical conditions
- Access to investigational treatments before they become widely available
- Ability to take a more active role in their own healthcare
- Access to free physical examinations and diagnostic tests related to the study
- Potential compensation for time and travel related to the trial