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Clinical research involves people like you participating in medical research studies. Clinical research involves the testing of investigational new drugs and devices to find better ways to treat, and understand human disease. These studies also provide valuable information about how disease and health progress. The primary purpose of doing clinical research is to gain more information about an experimental treatment, its risks, and its effectiveness.
Clinical Trials are part of Clinical Research. Clinical research studies (also known as clinical trials) begin with an idea. These ideas often originate in the laboratory. New therapies or procedures are tested in the laboratory and in animal studies. If the initial laboratory research is successful, researchers send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans. The next steps in a clinical trial of a new drug being tested in humans involve collecting data that will help determine whether a drug is safe and effective. Clinical trials are conducted in phases. Typically there are four phases. During a trial, more information is gained about an experimental treatment, device or intervention, its risks, and its effectiveness. Data from each phase of a clinical trial is submitted to the FDA for review before the next phase of the study can begin. Many Different types of people participate in clinical trials. Some are healthy, while others may have illnesses. A healthy volunteer is a person with no known significant health problems who participates in clinical trials to test a new drug, device or intervention. Healthy volunteers have always played an important role in research.
The process of developing a new drug from the original idea to launching a finished product is complex and can take 12–15 years. The drug discovery process begins in the laboratory. If a compound shows promising activity against a particular biological target it will be tested in what is called the pre-clinical phase of drug development. At the completion of pre-clinical testing the data is submitted to the Food and Drug Administration (FDA) which is the regulatory authority in the US. The FDA must approve the compound for testing in clinical trials. Once this approval is obtained the first phase of clinical trials can begin.
Click “Volunteer” from our menu bar and complete the application to volunteer. You may also call 1-800-254-6398 to speak with a phone screening representative to learn more. All studies have criteria that you must meet in order to qualify as a potential participant. Our phone screeners will determine what study/studies you might be eligible for.
All participating volunteers are compensated for their time and any inconvenience that may result from taking part in a study. The amount a study subject will be paid depends on criteria such as length of stay in the CRU, total number of study visits and the nature of the procedures involved during the study. By participating in a study you will receive a thorough medical evaluation including a physical examination and laboratory testing, compensation for your time and the chance to contribute to the development of a new medicine and possibly improving the health of others.
Click the “Volunteer” button from our menu bar to see a list of current studies that are available.
The Pfizer Clinical Research Unit (CRU) in New Haven, CT is a state-of-the-art research facility with fifty inpatient beds. The CRU is designed to provide comprehensive clinical care and monitoring of our clinical trial volunteers during their stay at the Unit. The CRU is highly computerized, using an electronic data capture and reporting system. It also houses sophisticated laboratories, including a biomarker lab and a research pharmacy. The Unit is complete with a cafeteria that serves meals and snacks according to the study directions. During their stay at the CRU, our volunteers have access to certain amenities such as internet, televisions, game room and more.
The informed consent document will be reviewed with you by members of the NHCRU clinical staff. The informed consent document is a means of educating you to all the details of the study as well as to your responsibilities as a volunteer so that you may make an informed decision as to whether or not you would like to participate. This is called the consenting process and is also intended to be a time for you to have your questions answered. The length of the screening visit can vary from two to three hours depending on the complexity of the study and what preliminary screening tests are required. If you decide to participate, you will undergo tests including (but not limited to), blood work, ECG’s, and vital signs to help determine whether you are eligible to be enrolled in the study.
Study volunteers are free to withdraw consent at any time.
As with any type of medical care or events of daily living, clinical trials can pose risks. The consent form will describe to you the known risks that may be associated with participating in a clinical trial. With the help of the NHCRU clinical staff, you may weigh the risk factors and decide whether or not you would like to participate.
The individual in charge of the study is called the Principal Investigator. Your care during the study will be delivered by a highly skilled and experienced clinical staff that includes physicians, nurses and other members of the healthcare team.
Once your results are in, you will be notified, by phone, as to whether or not you qualify for the study. If you are not qualified for the study you will be explained by the Principal Investigator as to why. You may request a copy of your test results at any time.
The length of time you will need to stay in the Unit is determined by the design of the study. Each study has specific criteria and can vary in total participation time as well as in the number of overnight stays required.