A clinical trial, also called a research study, is a process scientists use to test the value and safety of various interventions in people. Clinical trials are meant to find new and improved methods of evaluating or treating a condition or it can test a new way to prevent diseases.
Clinical trials are conducted in phases and may span long periods of time.
Phases of a Clinical Trial
- Phase I clinical trials involve giving a new treatment to a small number of participants. The researchers determine the best way to give the new treatment, how much of it can be given safely, and help identify possible side effects. Participants are usually people who would not be helped by other known treatments or alternatively, a phase I trial is performed in healthy volunteers to determine the safety of a particular treatment.
- Phase II clinical trials focus on learning whether the new treatment is effective for a specific condition. Additional information regarding the side effects and safety of the treatment is also obtained. A small number of people are included because of the risks and unknowns involved.
- Phase III clinical trials compare the new treatment with the standard treatment. In this phase, researchers determine which study group has fewer side effects and is undergoing the most improvement.
- Phase IV clinical trials, also called post-marketing studies, are conducted after a treatment has been approved. The purpose of these trials is to learn more details about the treatment and to address questions that may have come up during other phases of trials. They are also very important for collecting data on additional and rarer side effects in real-life patients.
Understanding Clinical Trials
Clinical trial participants in phase III trials are usually assigned at random (a process similar to flipping a coin) to either the new treatment (treatment group) or the current standard treatment (control group). Randomization helps to avoid bias (having the study's results affected by human choices or other factors not related to the treatments being tested). When no standard treatment exists for a condition, some studies compare a new treatment with a placebo (a look-alike pill/infusion that contains no active drug). Participants do not know if they receive the drug or placebo.
In a clinical trial, patients receive treatment and researchers observe how the treatment affects patients. The patient's progress is closely monitored during the trial. Once the treatment portion of the trial has been completed, researchers may continue to follow patients in order to gather more information about the effects of a treatment.
Such trials can involve risks, and there is no guarantee regarding a trial's outcome.
Clinical Trial Participants
While clinical trials have risks for the people who take part, each study also takes steps to protect patients. Only an individual can decide whether taking part in a clinical trial is worthwhile. The possible benefits and risks should be considered carefully.
Questions to Ask Your Doctor About Clinical Trials
- What is the purpose of the study?
- What has previous research of this treatment shown?
- What is likely to happen in my case with or without the treatment?
- Are there standard treatments for this condition?
- How does this study compare with standard treatment options?
- What are the possible side effects both now and later as the treatment continues?
Clinical Trials to Treat Pain
Trials testing treatments for various types of pain, including pain associated with arthritis, cancer, headache, nerve, and abdominal problems are currently underway. For the most current listing of clinical trials in the field of pain, please consult the web site www.clinicaltrials.gov.