After being diagnosed with a heart condition, or surviving a heart event, many people rely on prescription and over-the-counter medicines to manage their diseases. Most adopt healthier lifestyles, which include proper diet and exercise, but some undergo procedures for implantable devices, such as drug-eluting stents, ICDs or pacemakers. In many cases, healthcare providers recommend these medical procedures, because they have been proven to improve quality of life for many heart patients. These decisions are made as a result of rigorous clinical trials, and with the help of research participants. Individuals who participate in clinical trials help determine whether new biomedical or behavioral interventions are safe and effective for human use.
ClinicalTrials.gov, a government registry of federally and privately supported clinical trials conducted in the U.S. and around the world, currently reports that there are more than 110,000 clinical trials registered in more than 170 countries. In order to complete these trials, researchers have to examine a pre-determined number of research subjects —but for many researchers, finding research subjects that meet their criteria can be the most difficult part of the process. CenterWatch—an online source of clinical trials information for both clinical research professionals and patients—reports that 75 percent of the general public said they have little to no knowledge about clinical research and the participation process, thus making it even more difficult for researchers to make clinical trials possible.
As a registered nurse and Program Manager for Mercy Gilbert Medical Center’s Cardiovascular Research program, I cannot emphasize enough the importance of educating our communities about the clinical trial process. Research plays an essential role in the advancement, effectiveness and quality of medical treatment for everyone and research participants are the backbone of the scientific progress. They allow researchers to learn more about how well an experimental medication or procedure may or may not work.
I am delighted to be working with Mended Hearts to bring you more information about clinical trials. In future posts, I will take you through the research participation process—both the benefits and risks—as well as provide you with some great resources for learning more about participation.
Throughout this journey I welcome your comments and questions!
Ann Campbell, R.N., is the Program Manager for Cardiovascular Research at Mercy Gilbert Medical Center— a Dignity Health Member —in Gilbert, Ariz.
“In many cases, healthcare providers recommend these medical procedures, because they have been proven to improve quality of life for many heart patients.” It should be noted that in too many cases, healthcare providers recommend procedures because they are believed, without proof, to improve quality of life, until, and sometimes even after, clinical trials have proved the opposite of what was believed. That fact lends further urgency to the importance of clinical trials.
Ann,
Thank you for the information. I am the visiting chairman at The Gagnon Cardiovascular Institute at Morristown, New Jersey. Gagnon is one of (40) hospitals participating in the CoreValve TAVI trials but I do not find that catagory listed in the clinical trials list.
Vic
In an effort to further educate your readers, I would like to offer other suggestions for complete and balanced information about clinical trials participation including process, protection, benefits and risks. Here are some helpful resources (websites and book):
1) http://www.CISCRP.org (Center for Information and Study on Clinical Research Participation)
This non-profit organization is focused on educating and informing the public about clinical research participation. CISCRP provides valuable information including how volunteers can protect themselves.
CISCRP tries to help you locate ongoing clinical trials by supporting SearchClinicalTrials.org. CISCRP also helps those patients who are having difficulty locating clinical trials by conducting a custom search for them.
2) The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial (author: Kenneth Getz) – available on the CISCRP website.
3) And for specific trial listings and news about Clinical Trials, your readers should go to the website: http://www.CenterWatch.com There, they can search for clinical trials in their area or around the world, and they will find listings of clinical trials organized by medical condition, therapeutic area and location.
My goal is to help people feel empowered and protected as they participate in the Clinical Trials process. I hope you find these suggestions helpful.