Clinical Trials: Is There One that is Right for Me?
Clinical research is medical research that involves people.Clinical trials study new treatments for different medical, surgical, or behavioral treatments for different diseases and conditions.2-3 Clinical trials can also look at how to make quality of life better for people and to study the role of caregivers or support groups.
Heart failure clinical trials
There are hundreds of clinical trials in the fields of cardiology and vascular diseases that affect the structure and function of the heart and blood vessels. Study topics for clinical trials can range from angina to different vascular diseases. They can address heart function, heart defects, and comorbid conditions such as obesity and renal artery disease.4
Heart failure (HF) trials study many different elements of heart failure. HF trials that are actively recruiting patient volunteers can be found through a number of different web portals and through your healthcare team.3-4
Finding a clinical trial
ClinicalTrials.gov is a searchable database of the National Institutes of Health. It includes registry and results information about both federally and privately funded clinical trials conducted in the United States and around the world. ClinicalTrials.gov stores information about the purpose of a trial, who can enroll, the location of the trials, and contact information for more details.3,5
You can search for clinical trials by entering search terms that relate to your interests including the type of disease, intervention, and geographic location. Information on studies in the database does not mean that they are all federally approved study. Before applying or enrolling in a study be sure to talk to your healthcare team to understand the risks and potential benefits of participating.3
CenterWatch is both a professional and patient resource for clinical trial information. You can go to here to learn about clinical research including drug and device testing. It has a trial listing service portal for patients to locate clinical trials available here. You can search this website to find more detailed information on study options in your area.4
ResearchMatch is another NIH-funded initiative that can connect people who are trying to find research studies and researchers looking for participants for their studies. The registry is free and easy to use. Volunteers can connect with and become involved in clinical research studies.3
Phases of clinical trials
Phase I - the experimental treatment is given to a small group of people (20-80) to check its safety appropriate dosages and to identify side effects.
Phase II - tests effectiveness and continues to evaluate safety on a slightly larger group, 100-300 people
Phase III - experimental drug or treatment is given to larger groups of people (100-3,000) to confirm information about safety and effectiveness, monitor side effects, look at different populations and dosages, and make comparisons to commonly used treatments.
Phase IV - begins after a study drug or treatment has received FDA approval. They are called post-marketing studies; and they gather additional information including the drug's risks, benefits, and best possible use in a larger population.1,3
The selection process for participating in a clinical trial involves a screening process by the research team. There are specific criteria that the researchers are looking for. The process looks at age, gender, ethnicity, location and other demographic considerations to make sure the selected participants match the study requirements. Candidates may involve physical and mental health tests to make sure that participants can safely participate.3
Questions about clinical trial participation
Questions you might consider when thinking about whether participating in a clinical trial is right for you include:1,3
- Why is the treatment being tested?
- Does everyone get the same treatment or is there a placebo involved?
- Will I know which treatment I am getting?
- What will I have to do?
- How long is the study?
- What are the possible risks and side effects?
- Will I have to be hospitalized?
- Who will pay for the treatment?
These and any other questions you may have should be discussed with the study coordinator, your family, and your own personal healthcare team before consenting to participate in any clinical research.1,3
What can someone do to better support you? (Choose all that apply)