About Health Research
Q. What is health research?
Health research (which refers to clinical trials and studies) is the way we learn new and better ways to help people be healthier. Every trial or study is a partnership between members of the community (you), doctors, and researchers. The results determine whether these new ideas do a better job at treating or preventing a disease and ultimately improving medicine for everyone.
You may hear a lot about how important your participation is in clinical research. Participation from volunteers ensures there are ongoing advances in the medical field. More than that, it's the only way medical breakthroughs can reach the public. Clinical research - and your involvement in it - plays a crucial role in improving the health of current and future generations.
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Q. What are the different types of clinical research?
There are several different kinds of clinical research and not all involve new treatments for a disease.
Intervention studies look at specific medications, procedures, and devices to see if they are more effective at treating a disease or medical condition, or at modifying risk behaviors. (Risk behaviors are lifestyle choices that increase a person's chance of suffering from a particular condition.)
Prevention studies help determine how we can better prevent a certain disease or condition from occurring in healthy people.
Diagnostic and screening studies search for better ways to detect and diagnose disease.
Behavioral research seeks to identify how certain behaviors are related to a variety of diseases, and how these behaviors can be modified.
Quality of life studies look for ways to help those with chronic or incurable diseases.
Observational studies follow participants over a period of time - monitoring their health over the course of months or years - without changing their treatment.
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Q. What kinds of conditions and diseases is URMC researching?
At any given time, we're involved with hundreds of studies, performing clinical research on dozens of diseases, from diabetes and cancer to muscular dystrophy, arthritis, and many more. We also do research involving healthy people, looking at ways to prevent diseases with things like vaccines and healthier lifestyles.
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Q. What are the phases of a clinical trial?
Clinical trials have four phases. Each has a different purpose and provides important information for the researchers. Think of the phases as a chain of events - the researchers use the findings of each phase to determine how or if to proceed with a study. You'll see that safety is a priority from the very beginning.
Phase I Trials help evaluate the safety, side effects, and proper dosage range for a new drug or treatment. Let's say a researcher has found what might be a promising idea and has reached the point where the drug is ready to be evaluated on people. In the Phase I Trial, researchers typically ask for a group of 20-80 healthy volunteers. These volunteers help researchers determine if the medication is doing what the researchers predicted, if the medication amounts are accurate, and to make sure there are no unwanted side effects.
Phase II Trials involve a greater number of volunteers, usually 100-300 individuals of which a portion have the specific condition the medication or therapy is trying to treat. In Phase II Trials, volunteers help researchers study effectiveness by seeing whether or not the medication, behavior, or therapy is actually having an impact on the condition that's being treated. Safety evaluations are continued as well.
Phase III Trials expand to a much larger group; anywhere from 1,000-3,000 individuals and multiple medical centers are often involved This phase is really a bigger version of Phase II with one exception; the group of volunteers tries to represent the broader demographic you see in our communities. For this to happen, researchers need volunteers of different ages, genders, health, race, and ethnicity. This allows researchers to look for reactions that might affect a certain population such as people with pre-existing or inherited conditions. Researchers look closely at how the new approach compares with the best drugs or treatments currently available.
Phase IV Trials take place after a new drug or treatment has received permission to be sold. Researchers watch for rare side effects, study interactions with other drugs, consider other uses for the new drug or treatment, and examine how it works in select populations.
After a Trial
No matter the final outcome, every trial is valuable and considered a success. Sometimes what started as a promising idea is now available to the public and supported with research, findings, and knowledge. Other times, results lead scientists to entirely new ways of thinking about how to help people live healthier and feel better. Either way, researchers make important discoveries. And all of it was made possible because of volunteer efforts.
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