A clinical study is research in human volunteers intended to answer particular health questions. These questions might be about whether or not a certain medication or medical device is effective, has side-effects or what the best dose is for effective treatment. Clinical trials are designed to find treatments to improve health and future medical treatments.
Medical treatment cannot improve without research and volunteers. Everyone would like a successful treatment available when diagnosed with an illness. By volunteering you can help advance knowledge about future treatments that someday you or a loved one may benefit from. In a research study you have the opportunity to take an active role in your own health and access a possible investigational medication that is not otherwise available. No treatment may reach clinical testing unless there is evidence that there might be an improvement over current therapies. Participants often benefit from the added care and attention a clinical study offers. In clinical research, all investigational-related care and medications are provided at no cost to the patient. Along with the investigational-related labs, medications, and exams most studies also offer compensation to the participants in return for their time and travel. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
The clinical trial process depends on the kind of trial being conducted. To see the different phases of clinical trials, please look below.
The clinical trial team includes doctors and other health care professionals. Our team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is the most successful when the protocol is carefully followed and there is frequent contact with our research staff.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, our staff will explain the details of the study. Then our research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to: Play an active role in their own health care, gain access to potentially new treatments and help others by contributing to research.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol which is a study plan that details what researchers will do in the study. As a clinical trial progresses, researchers might report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain confidential and will not be mentioned in these reports.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain confidential and will not be mentioned in these reports.
Phase I trials determine the basic safety of a drug or treatment and the affects it may have on the body. Lasting anywhere from a few days to a few months, these studies are preformed on small groups of people (typically 10 to 100). Phase I studies also help to determine safe dosages and identify side effects.
Phase II trials are conducted on larger groups of people (typically 100 to 200) and look at the drug or treatments safety and dosing for people who suffer from a specific disease or condition.
Phase III trials are conducted on very large groups of individuals (300 - 3,000) and are designed to determine effectiveness, monitor side effects relative to existing drugs used to treat the same disease and to collect information that will allow the drug or treatment to be used safely.
Phase IV trials begin after a drug has been available on the public market. These studies help investigators prove the safety of a specific drug or treatment in a more diverse group of volunteers and the effectiveness of dosage, formulations and new uses that may not have been considered previously.
For more information go to The Center for Information and Study on Clinical Research Participation at www.ciscrp.org.