Types of Research
Clinical research studies conducted at UMass
UMass conducts hundreds of clinical research studies at any point in time. Some studies are observational studies. These studies follow participants’ health over a period of time and do not test drugs or treatments. Some studies are interventional studies that test the safety and effectiveness of a new treatment, drug or device.
There are five types of studies: Prevention studies help researchers learn how to prevent diseases or, in some cases, prevent the disease from returning. These studies test how changes in medicine, nutrition, exercise or other lifestyle changes prevent disease and improve health. Screening trials help test the best way to detect certain diseases or conditions. Quality of Life studies are conducted to learn about improving the quality of life and comfort for patients who have a disease or condition. Genetics studies examine how genes increase or decrease the risk for certain diseases. Clinical trials test new devices, treatments, procedures or drugs in order to prevent, cure, or slow the progression of certain diseases or conditions. Treatment trials are typically divided into Phase I, II, III or IV trials.
Phases of Clinical Trials
The U.S. Food and Drug Administration (FDA) require that treatment trials be tested in four phases:
Phase I: Researchers test a new device, treatment, procedure or drug on humans for the first time. The goal of a Phase I trial is to prove that the new treatment is safe for humans. For this reason, Phase I trials are usually done using very small numbers of volunteers (usually fewer than 80). The results of the trial provide important data on safety, dosage, the best route for administration, and potential side effects.
Phase II: Clinical trials are conducted when the results from the Phase I trial indicate that the new treatment is safe. The treatment will be tested on more volunteers (usually 100 to 300). Testing patient safety and effectiveness are the key elements of the trial.
Phase III: Clinical trials seek to confirm the effectiveness of the treatment. The trial also compares the treatment to other available treatments and monitors side effects. Typically multiple research sites are involved and 1,000 to 3,000 volunteers are enrolled in a Phase III trial. The trial evaluates whether the benefits of the new treatment outweigh the risks.
Phase IV: Clinical trials are conducted after the treatment has received FDA approval and is available for use. Phase IV trials evaluate long-term effects and explore possible new uses for treating other diseases or conditions.
If you decide to enroll in a clinical trial, the researcher will carefully explain the details of the study including the phase, the risks and the benefits.