The Clinical Trial Experience – Part 3

If you have never participated in a clinical trial, you may have questions and concerns about what to expect. The length of time and activities expected from research subjects can vary drastically depending on the nature of the study. Potential research subjects may or may not be aware of the benefits of their participation in the clinical trial process.  However, involvement cannot only impact the outcome of your own health, but the level of care received by others being treated for similar heart conditions. Although these trials differ in a number of ways, there are a few things research subjects for almost all clinical trials can expect.

As a potential participant in a clinical trial, you should expect to:

• Be screened (sometimes initially by phone) to make sure that you qualify for the study. Screening can also involve a physical exam that may include blood and urine analysis, a heart trace (electrocardiogram), and other diagnostic tests required by the study protocol. It is important to note that information obtained during the screening process is kept confidential.

• Sign an informed consent document. The site staff will also ask you to review and sign an informed consent document which ensures that research subjects are aware of the risks associated with participating in the study. If you are eligible to become a research volunteer for the study, the staff will provide you with specific instructions for participating. At this stage a staff member can answer additional questions that you may have about the participation process.

Once you are enrolled, the clinical trial team will check your health at the beginning of the study, give you specific instructions for participating, monitor you carefully throughout the trial and will likely follow up to check your status after the study is complete. Some studies can be more involved than others and require more tests and doctor visits than normal. If you would like to learn more about what to expect as a clinical trial participant, you can visit ClinicalTrials.gov and/or CenterWatch.com.

Dignity Health has more than 40 hospitals and medical centers throughout Arizona, California and Nevada. Residents in these states, who are interested in learning more about Dignity Health’s services, including our research programs, can visit www.DignityHealth.org to locate hospitals and/or clinical trials in their area.

Ann Campbell, R.N., is the Program Manager for Cardiovascular Research at Mercy Gilbert Medical Center— a Dignity Health Member —in Gilbert, Ariz.

Finding the Right Clinical Trial – Part 2

At any given time, there are a variety of incredibly diverse clinical trials underway throughout the country. In order for these studies to be successful, recruiters for clinical trials need to enlist a number of qualified subjects in order to evaluate the effects of therapies such as medications, devices and/or behaviors.

Research subjects who participate in clinical trials receive careful medical attention including examinations and tests at no cost.  In some cases, they may even be reimbursed for time, travel and other expenses. It is important to know that participation is not without risks. There are risks and possible side effects specific to every clinical trial. These risks should always be listed in the informed consent form and will be discussed with the research team before you enter the trial. However, for your safety, there are other precautions that you might want to take before signing on to participate in a clinical trial.

Before you become a research volunteer…

Talk to your doctor. While online resources are tremendously helpful, I want to emphasize the importance of talking to your healthcare provider about information on clinical trials. Many of the volunteers who participate in the research studies that are conducted throughout Dignity Health hospitals are referred by medical staff members of affiliated institutions. Your healthcare provider or treatment facility may prove to be a valuable resource in your journey to finding the right study.

Pay attention to the study enrollment criteria. If you don’t fit all the necessary criteria you will not be considered for the study. It is important to note that these criteria are not used to reject people personally, but instead, are used to identify appropriate participants and ensure that researchers can answer the questions they plan to study. If you are unsure about any of the criteria, speak with your doctor or contact the clinical trial team member that is listed as part of the trial information.

How to find research trials in your area?

Research sites promote their studies to the public through a number of ways. If you know where to look, you may be able to find relevant clinical trials in your area. Below are a few websites you can visit to locate studies in your area that you may qualify for as you consider becoming a research participant.

• CenterWatch.com sponsors a free Patient Notification Service that automatically emails subscribers as soon as a clinical trial is posted that matches their medical condition and geographic area.

• ClinicalTrials.gov is another valuable resource where those interested in volunteering for clinical trials can search an extensive database based on several criteria, including location and disease.

Identifying the right clinical trial can be both educational and rewarding. So you may be asking “what happens once I’m enrolled in a trial?” Stay tuned for my next post where I’ll provide an overview of the participation experience.

Mended Hearts wants to hear from you. Please feel free to leave comments here about your own experiences as a research participant!

Ann Campbell, R.N., is the Program Manager for Cardiovascular Research at Mercy Gilbert Medical Center— a Dignity Health Member —in Gilbert, Ariz.

The Importance of Participating in Clinical Trials – Part I

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.