Clinical trials are controlled research studies in which the patients voluntarily agree to participate. The studies are done to evaluate the safety and effectiveness of an investigative treatment. Clinical studies are done to provide information about new treatments and improve the quality of life for patients. Clinical trials can involve many years of research and be completed in phases.
Phase I-A Phase I trial is the first trial with an investigational product to evaluate how the investigational product should be given and to identify side effects. The Phase I trial may involve people without the illness or condition (healthy volunteers) or it may involve patients who have the illness or condition.
Phase II-A Phase II trial involves testing the investigational product in people with a particular illness or condition. Phase II trials gather preliminary information on the potential benefits of the investigational product and additional information on side effects.
Phase III-A Phase III trial is designed to compare the effectiveness and safety of the investigational product to medications, medical devices, and other treatments that are already available and approved by the FDA (Food and Drug Administration). Patients enrolled in a Phase III study, in general, are randomly assigned to receive one of the following:
- The investigational product
- The standard treatment
- An inactive medication or treatment called a Placebo.
Phase IV-Phase IVtrials are generally conducted after the FDA has already approved a product. A Phase IV trial is conducted to provide additional information on safety and effectiveness.
Placebos are copies of a study medication with the exception that they contain no medication. Placebos assist in determining whether the studied medication is successful by comparing patients that receive medication versus patients receiving the placebo. Not all studies use placebos.
Participates in clinical trials have access to medical treatments before they are available to the public, have an active role in their own healthcare, save medical costs by participating in trials, and are contributing to important medical research that will help other people.
The risks of participating are that the protocol may require more time and attention (i.e.., trips to the study site, additional treatments, complex medication requirements) than a more traditional treatment and also the experimental treatment may not be effective for every study participant.
There is no cost to you. All prescreen, study visits, and tests associated with the study are covered by the sponsor. In fact, most studies provide a stipend to you as compensation for time and travel.
Anyone who is 18 or older and who meets all of the study criteria for the particular study.
As with any treatment, the patient must decide if the benefits outweigh any possible side effect. The participant will work together with the clinical research coordinators, and the study physicians will carefully monitor the participants overall health and address any concerns accordingly.
Legal and ethical codes that govern a medical practice apply to clinical trials as well. In addition, safeguards are built into clinical research by federal regulations to ensure the safety of the participant. Clinical trials follow a detailed protocol and all participants are monitored to make sure that the participant is not exposed to a harmful treatment. The results of the clinical trial are reported and shared at scientific meetings, medical journals and provided to various government agencies. The participants will remain anonymous and will be de-identified for all study related activities.
Yes, a participant is free to leave a clinical trial at anytime with no risk of it effecting his/her medical care. We ask that when leaving early you inform the research team and share the reason for not continuing the trial. A close out visit will be provided for the participant.