Click Here to Search orCall 703-204-3366 forMore Help Finding a Physician.
Why Are Research Trials Important?
Medical treatments have come a long way in the last 30 years. Today, many more patients are surviving serious illnesses that they might not have years ago. This is due to improvements in medical treatments and recognition of the special medical and nursing needs of patients. These improvements have come about through research, both in the laboratory and in the clinical setting. However, there still are many questions to be answered about treatments for patients and the care they receive. Finding answers to these questions is why research is an essential part of Inova Health System.
Helping to Answer Health Care Questions
Inova Health System conducts two types of clinical trials: industry-sponsored and investigator-initiated. Research projects at Inova hospitals provides answers to questions regarding the care of patients. They also contribute to the growing body of medical knowledge about different conditions and treatments.
You may be asked to take part in a research trial or to give permission for a family member who is not able to make the decision for themselves. Because this request sometimes comes at a time of emotional stress, we would like to provide some general information explaining research, to help you make an informed decision.
What Is a Clinical Trial?
A clinical trial is a thorough and carefully controlled evaluation of a new medical test or treatment.
Before a clinical trial begins, the treatment must show that it has potential benefit. It also must meet rigorous government standards and scientific requirements for safety, and have acceptable side effects.
Ultimately, the only way to determine the true benefit and safety of a treatment is to test it on people with the disease or condition for which the treatment was developed. Clinical trials are one of the steps in determining how effective a drug or treatment is in combating a disease or medical condition.
Types of Clinical Trials
There are many different types of clinical trials and many ways patients and their families can participate. A clinical trial can:
Here are explanations of the four phases of clinical trails:
Phase 1
These are the earliest trials in the life of a new drug or treatment. They are usually small trials, involving up to 30 patients (often a lot fewer).
When initial laboratory research shows that a new treatment might help treat a specific disease, Phase 1 trials are done to find out more about:
Phase 1 clinical trials may be done on healthy subjects or those with a specific disease.
The aim of Phase 1 clinical trial is to look at different doses and side effects. This work has to be done first, before we can test the potential new treatment to see if it works. Phase 1 trials are important because they are the first step in finding new treatments for the future. Subjects in Phase 1 clinical trials will be given a small dose of the drug being tested. If all goes well, the next subject will get a higher dose. With each subject taking part, the dose will gradually be increased and the effect that it has will be carefully monitored. Any side effects will be recorded. In a Phase 1 trial, you may have lots of blood tests as the researchers look at how the drug is affecting you, and how your body copes with the drug.
Phase 2
About 7 out of every 10 new treatments tested at Phase 1 make it to Phase 2 trials. These trials may be done on people who all have similar diseases. Phase 2 trials are done to find out:
Although these treatments have been tested at Phase 1, there may still be side effects that are not known. Drugs can effect people in different ways.
Phase 3
These trials compare new treatments to the best currently available treatment and/or placebo (the standard treatment). They may compare:
Phase 3 trials are usually much larger than Phases 1 or 2. Because differences in success rates may be small, many patients are needed in the trial to show the difference.
Phase 3 trials sometimes involve thousands of patients in many different hospitals, and even different countries. Generally, Phase 3 trials are required before approval of a new medication or treatment.
Systematic Reviews and Meta Analysis
Systematic reviews are studies that combine the results of multiple Phase 2 and 3 trials of a new treatment or diagnostic tests. Another type of study that will combine research results is meta analysis. The idea is to get a broader picture of how well a treatment works and how many side effects it potentially has. The more data there is, the more accurate such studies are likely to be.
Phase 4
Phase 4 trials are done after a drug has been shown to work and has been approved. In Phase 4 clinical trials, more long-term data about the efficacy and safety of a drug or device are gathered. Phase 4 clinical trials are run to find out more about long-term side effects and the safety of the drug or device, what the long-term risks and benefits are to the patients, and how well the drug/device works when it is used in clinical practice. Phase 4 trials look at drugs/devices that are already available for doctors to prescribe, rather than new ones being developed.
How Clinical Trials Are Conducted
Physicians, nurses and other researchers follow strict rules when conducting clinical trials. These rules protect the interests of the patient and remove any bias from the study.
The best available research design is known as a randomized, controlled, double-blind clinical trial. Here's how it works:
What is an Investigator-Initiated Research Study?
An investigator-initiated research study is also a thorough and carefully controlled study. However, in this type of study, the concept and the protocol is conceived by our own clinician rather than a pharmaceutical or device company.