Here at Mountain Kidney and Hypertension Associates we are pleased to participate in clinical research trials. Doing so allows us the opportunity to further our knowledge regarding the treatment of chronic kidney disease and hypertension, and to offer our patients access to promising experimental therapies that are not generally available. We have recently been involved in interventional trials that have looked at new ways to treat anemia, bone disease and iron deficiency. Please feel free to ask your physician if there are any current study opportunities that might be of benefit to you.
Understanding Clinical Trials
What is a Clinical Trial?
A clinical trial is a research study to answer specific questions about new medications, vaccines or therapies to prevent or treat certain illnesses. These studies can also help us find new ways to use existing treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective
Why Participate in a Clinical Trial?
Participants in a clinical trial can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who Can Participate in a Clinical Trial?
All clinical trials have guidelines about who can participate. These guidelines are generally referred to as inclusion/exclusion criteria. 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.” Before joining a clinical trial a participant must qualify for the study. These criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What is a Protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what type of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What is Informed Consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document.
Can a Participant Leave a Clinical Trial After It Has Begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
How is the Safety of the Participant Protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.
The above information is modified from the National Institutes of Health Clincial Trial website. It is used with permission of the National Library of Medicine. Please visit http://www.clinicaltrials.gov for further information regarding clinical trials.