Whether you have been referred by your doctor or found us by other means, the following information has been compiled to give you an overview about volunteering in a Research Study (also known as a Clinical Trial).
Aside from your doctor's private practice he/she may also be an investigator for Medical Research Studies.
As an Investigator, doctors take a step to help medical science discover and/or improve current medications. Investigators are compensated for their services as well as research volunteers are compensated for their time and transportation expenses during the course of the study participation. The terms and conditions are usually discussed during the screening period.
What is a Research Study?
A Research Study (also known as a Clinical Trial) is a study in which people volunteer to test a new medical treatment. By conducting research studies, we learn whether new medications are safe and effective. Also, currently approved medications may undergo testing for the treatment of new indications. Research studies are needed to develop new medications for many conditions, including: high blood pressure, arthritis, migraine’s, reflux, diabetes, insomnia, Alzheimer’s, etc. Once a new drug is found to be safe and effective, it may be approved by the FDA for doctors to prescribe.
All Clinical Research is based on a set of rules or regulations. For each clinical trial a protocol will be generated to describe step by step what is the study about, what it serves and how it will be carried out. Furthermore, it describes the study, who can participate, the procedures to be followed, the length of the study, the doses of the study medication and side effects.
Clinical Research consists of studies that attempt to answer some specific questions about new medications or treatment modalities for a specific indication. Clinical Research Trials are not only looking for beneficial effects, but also for safety and tolerability evaluating all the adverse effects.
CLINICAL RESEARCH TERMINOLOGIES
Clinical Investigator or Study Physician
A medical researcher in charge of carrying out a clinical research study. Researchers are usually doctors, nurses, clinical coordinators or other healthcare professionals.
Clinical Research Study
A process designed to study the effects and/or safety of an investigational medication, medical treatment or device on a group of volunteers.
Food and Drug Administration (FDA)
A government agency that enforces laws on the manufacturing, testing and use of drugs and medical devices. The FDA must approve a drug for marketing before it can become readily available to the medical community and the public.
A discussion of procedures, benefits and risks of a clinical research study between clinical investigators and persons interested in participating in the study. The FDA requires that volunteers sign an informed consent form (approved by the IRB) before entering a study.
Institutional Review Board (IRB)
A group of healthcare professionals as well as members of the local community. The IRB carefully reviews clinical research study activities, as it is responsible for protecting the safety and the rights of the volunteers.
BENEFITS, RISKS and PARTICIPATION
Which are the benefits of a clinical research study?
Many studies are not designed to directly benefit participants. However, the search for particular characteristics of a disease or the effects of different drugs could allow to develop new therapeutic targets and with this make a more personalized treatment of a disease. In addition, thanks to altruistic participation, the community can benefit significantly by finding new ways to address a clinical indication.
Which are the risks of a clinical research study?
Participants may experience side effects or adverse reactions to investigational drugs or treatments. There is a possibility that treatment may not be effective in some people. The protocol may require much of the participants' time, constant appointments to the study site, hospital stays, treatments, and complex requirements regarding the doses to be used. The person who participates in an investigation must be as informed as possible of the study they are willing to participate. It is important that the volunteer feels comfortable asking, and that the staff answers their questions in a way that the person understands correctly.
Who can participate in a study?
Individuals who wish to participate in these investigations must meet certain conditions or requirements to be admitted to a clinical trial. Some studies look for volunteers with certain diseases or medical conditions that they want to study, while other studies require healthy participants.
Why should you join a research study?
You can play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
How does a research study work?
Research studies are supervised by qualified doctors and researchers who work as a team with other doctors, nurses and health care professionals. If you are interested in participating in a clinical trial, you will meet with someone from the study team who will provided an explanation and answer any question. If after the discussion, you want to participate in the study, the study coordinator will give you an informed consent document to read and sign.
The informed consent describes what you can expect from your participation in the study such as the frequency of the study visits, what procedures will be done during the study, any potential benefits and possible risks of participating in the study. It is very important that you take your time and read the informed consent document carefully. If you have any questions regarding the document, you should discuss them with the study doctor and study coordinator. Once you are satisfied that you understand all of the information given and that all of your questions have been answered, you will be asked to sign the informed consent document. After signing the informed consent, information will be obtained from you to see if you meet the requirements for study enrollment. Once eligibility is confirmed you will be enrolled in the study.
You should note that different studies have different requirements, but generally during the study you can expect:
To be assigned to a group that is given the study drug or to a group that is given a placebo (an inactive product, like a sugar pill)
Your medical history to be reviewed
To have a physical exam
To have your blood drawn for study specific tests
To be asked to complete several study visits
Your health to be checked throughout the time you are in the study
What questions should I ask if I want to participate in a Research Study?
It is important that you know as much as possible about the clinical trial so that you can make an informed decision as to whether or not you want to participate.
Here are some questions you may want to ask:
What is the purpose of this research study?
How long will I be in the study?
What kinds of tests and procedures are involved in the study?
Is there a chance I will receive a placebo (inactive substance)?
Can I leave the study at any time?
Will my records be kept confidential?
How do the risks, side effects and benefits in the study compare with the current treatment?
Are there alternative treatments available?
Who will pay my medical bills if I am injured during the study, and who should I contact if I am injured?
The answers to these questions can also be found in the informed consent. When considering whether or not to participate in a research study, you may request a copy of the informed consent for your review and to discuss with your physician, family and friends.
Can I leave a research study once it has begun?
Yes. You are free to leave the trial at any time. If you do decide to leave, you should let the study team know and tell them why you are leaving the study. Early study termination procedures will be done to ensure your safe exit from the study.
Can I be compensated for participating in a research study?
Yes, most studies compensate you for your time and travel.
Where can I get more information about research studies?
There are several organizations that offer information about research studies. Here are a few:
If you are interested in participating in an existing or future clinical trial and for information regarding the center, please send us your contact information, this information will only be used for this, one of our experts will contact you.
You can also call us @ 786-220-6738