Clinical Trials
Innovative Clinical Research
Medical researchers are always coming up with new treatments and medications to treat diseases. At a certain time in the testing procedure, the research leads to a point where it can be given to study subjects. However, these treatments have not yet been fully tested and, while research is promising, it cannot be confirmed that the treatment will be more effective than the current standard of care. This is where clinical trials come in.
What Is a Clinical Trial?
Clinical trials allow patients who agree to participate in these trials as study subjects the chance to participate in cutting-edge treatments or therapies that may prove to be the best method of curing or managing certain condition(s). Clinical Trials might be testing new drugs or combinations of drugs, new surgical procedures or devices, or new ways to use existing drugs, devices, and/or treatments. Clinical trials may also test new or different methods for delivering care.
We participate in prestigious medical and surgical research trials that provide patients access to promising new research/trial treatments. There are risks involved. Participation in clinical trials is completely voluntary and may be a helpful option to a patient including those who may have/have not had success in their treatment thus far.
Should I Participate in a Clinical Trial?
Participating in an experimental medical treatment may sound intimidating, yet there is a reason so many patients agree to them. Major medical breakthroughs are dependent on clinical trials and the people who volunteer to participate in them.
Not only does participating help to advance medical science as a whole, but the treatment could make much more headway in fighting your condition than the methods currently available.
For ethical reasons, medical professionals do not offer clinical trials to patients who already have an effective treatment method available. For instance, if a patient had cancer and was responding well to chemotherapy, it would be irresponsible and dangerous for a doctor to offer them participation in a clinical trial. Alternatively, if a patient’s cancer treatments had not yielded much success, the doctor may inform them of the clinical trial and ask if them would like to participate in the new form of treatment.
Questions to Ask Before Joining a Clinical Trial
If you are thinking about joining a clinical trial, here are some questions you may want to ask your doctor and the study research team:
- What is the purpose of the trial?
- Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
- How long will I be in the trial?
- What kinds of tests and treatments are involved?
- How will the doctor know if the treatment is working?
- How will I be told about the trial’s results?
- How long do I have to make up my mind about joining this trial?
- Who can I speak with about questions I have during and after the trial?
How Does a Clinical Trial Work?
A clinical trial is done in phases, and each phase brings the researchers closer to final approval of the drug or technique being studied.
- Phase I: The first attempt at determining whether a drug, device or therapeutic method is safe. In this stage, researchers identify side effects and establish safe doses. This phase typically tests fewer than 100 people.
- Phase II: This phase tests a larger group of people, typically 100 to 300, using the learnings from phase I. Continued monitoring of side effects. Researchers gather more information that will be needed for the rollout of a large, phase III trial.
- Phase III: This phase is designed to prove whether a set medical approach works. Continued monitoring of side effects. This phase testes as many as are able to enroll. Can be 1,000 or more.
- Phase IV: During the marketing phase, researchers continue to gather information on the effects of the drug, device or approach. Thousands of people can be enrolled in this phase of the trial.
What to Expect During a Clinical Trial
Typically, in a clinical trial, the following steps will take place:
- Information gathering. Researchers will explain the trial to the volunteer patient and learns more about them and their medical history.
- Consent. The volunteer is asked to sign a form indicating that they understand what is expected of them as a participant, and that they understand the various outcomes that could occur.
- Screening. The clinical trial volunteer is screened to make sure they qualify for the trial or study.
- Baseline visit. The baseline visit is the first appointment, at which researchers conduct cognitive and/or physical tests.
- Group assignment. For some trials that test an intervention, volunteers are randomly assigned to either a treatment group or a control group. The treatment group will receive the intervention being tested, and the control group will not.
- Trial in progress. The volunteer follows the clinical trial protocols and reports and issues or side effects to the researchers.
- Check-ins. There may be periodic check-in visits with the research team during which the researchers may evaluate the volunteer’s health. They may conduct cognitive, physical or other evaluations. During these visits, the research team collects data and monitors your safety and well-being.
When the volunteer’s participation is the study is complete, the researchers may offer access to information about how they may find results once the study data is available and has been analyzed.
Find a Clinical Trial
RWJBarnabas Health participates in clinical trials to help our patients receive the latest available treatments and to advance scientific progress. We maintain a database of trials that are currently open at any one or more of our facilities. Click the button below to find trials by type and location.
Being Contacted for Participation in Research
Research studies play a vital role in aiding health care providers in identifying disease prevention, diagnoses, and treatment.
Deciding to participate in a research study is a very personal choice. You always have the option to opt-out of being contacted about research and may do so by completing the RWJBarnabas Health Research Invitation Opt-Out form (PDF).
Please note that even if you opt-out from being contacted, your physician or care team may still discuss clinical trial opportunities with you.
If you previously submitted an RWJBarnabas Health Research Invitation Opt-Out form but now have changed your mind, you must complete, sign, and submit the Cancellation of Prior RWJBarnabas Health Research Invitation Opt-Out form (PDF), which will update your decision going forward to opt out from being contacted about research.