WHAT IS A CLINICAL RESEARCH TRIAL?
The clinical research trials performed at NMHI are health-related studies involving human subjects and that follow a pre-defined protocol. There are many different types of research protocols; in some studies, patients will receive a drug or device and will be informed about what they are being prescribed while other protocols may have patients “blinded” to what is being assigned.
WHY SHOULD I PARTICIPATE IN A CLINICAL TRIAL?
As a participant in a clinical trial, you will:
- Play an active role in your own health care,
- Possibly gain access to new research treatments before they are widely available,
- Obtain expert medical care at NMHI during the trial,
- Help others by contributing to medical research.
Your participation in a research trial is totally voluntary and you may choose to withdraw from a study at any time.
WHAT ARE THE RISKS TO PARTICIPATING IN A CLINICAL TRIAL?
As a participant in a clinical trial, it is important to understand that risks may be associated with your involvement.
- You may experience side effects which are defined as any undesired action or effect of the experimental drug or treatment. The side affects known at the time you enter a trial will be explained to you in detail.
- The experimental treatment may not be effective for each participant.
DO I CONTINUE TO WORK WITH MY PRIMARY HEALTH CARE PROVIDER WHILE IN A TRIAL?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, you can ensure that other medications or treatments will not conflict with the protocol.
The clinical research team includes doctors, nurses and Clinical Research Coordinators. The team checks the health of each participant prior to entry into the trial, provides specific instructions while participating in the trial and monitors each participant carefully throughout the trial.
All clinical trials have inclusion/exclusion criteria that help to both protect the safety of the patient as well as produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, the type and stage of a disease, medical history and previous treatment, as well as many other medical conditions.