What is a clinical trial?
A clinical trial is a research study conducted with human volunteers to answer a specific health care question.
What is a protocol?
All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan that describes…
- What will be done in the study
- How it will be conducted
- What data will be collected
What is Informed Consent?
- Your participation in any clinical trial is voluntary. Before you volunteer to participate, you will receive an Informed Consent document that explains the details of the study, including the potential risks and benefits, as well as your rights and responsibilities.
- A member of the research team will discuss the study with you and answer your questions so you can make an informed decision about whether or not to participate. In addition, you have the right to ask questions throughout the course of the study and may withdraw your consent (stop) at any time.
- Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources
Who can participate in a clinical trial?
- All clinical trials have guidelines about who can participate in a study. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Some research studies seek volunteers with illnesses or conditions to be studied, while other trials need healthy volunteers.
- Factors that allow you to participate in a study are called "inclusion criteria". Factors that keep you from participating are called "exclusion criteria". The criteria are not used to reject people for any personal reason, but rather are used to identify appropriate participants and keep them safe. The criteria also help researchers ensure they will be able to answer the questions they plan to study.
There are many reasons you might choose to participate in clinical trials. Here are just a few reasons:
- An opportunity to help researchers possibly find better treatments for yourself and for people in the future.
- Clinical trials offer you a chance to try new or experimental treatments that otherwise might not be available.
- Receiving medical care from a physician, study medication and laboratory care is provided at no charge to you or your insurance company.
- Enables patients to play an active role in your own health care.
What should I expect if I participate?
If you decide to participate in a clinical study, you will be asked to sign an Informed Consent form. This shows that you have been educated to all the aspects of the trial and you are willing to participate in the activities of the trial. All of the risks and benefits and the purpose of the research are provided during the consenting process.
Most studies will require that you have several things completed, a few examples are; a history and physical, blood specimens obtained, heart monitoring (ECG), radiological exams, such as x-ray, CT, and/or MRI. Depending on the design of the protocol, the study specific procedures and tests may be billed to your insurance company as standard of care or be provided by the sponsor. If it is determined that you are eligible to participate in the clinical study, you will be asked to return to the facility for a series of visits based on the study guidelines.
The clinical trial team includes doctors and nurses as well as other health care professionals. These team members will check your health at the beginning of the trial, give specific instructions for participating in the trial, and monitor you carefully during the trial. Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work closely with the research team. Your participation in the clinical trial is most successful when the protocol is carefully followed and there is frequent contact between yourself and the research team.
What are the benefits and risks of participating in a trial?
- There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you may benefit by:
- Gaining access to experimental medications that are not yet available to the public
- Playing an active role in your own health care
- Helping others by contributing to medical science
- Clinical trials may also have risks:
- There may be unpleasant, serious or even life-threatening side effects from participating in clinical trials
- Experimental medications may not be effective for some individuals
- The study may require frequent visits to the study site, or hospital stays
Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources
What protections are available for participating in a clinical trial?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is a committee of physicians, statisticians, patient advocates, and other members of the community that reviews the protocol, or study plan, to ensure that the study is scientifically sound, ethical and that participants are not likely to be harmed.
An IRB can discontinue a study if it appears to be causing unexpected harm to participants, or if there is new evidence that the risks outweigh the benefits.