Why Participate in a Clinical Trial?

A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Please refer to our Current Trials website for currently enrolling trials. If you would like to be considered for participation in one of our studies, you will be able to access our Individual Trial Page. This page will allow you to submit your information directly through our website.

When you contact us, you will be asked several questions about your current health. If you meet the study requirements, we will schedule an appointment for you to be evaluated by our staff. If you do not qualify for a specific study at that time, with your permission, we may contact you regarding future clinical research studies.

Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics. The location depends on who is conducting the study.

Participants in clinical trials 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. Many volunteers find that participation in clinical trials helps them have a better understanding of their medical condition and their potential treatment options. Often, patients feel they get even more attention and oversight of their care while they are in a clinical trial. Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative or diagnostic products or interventions.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to 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, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the 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.

No, Clinical research trials can be a great opportunity for people to receive medical services that are part of the study at no out-of-pocket cost or insurance cost.  Costs for care or medications that you would receive even if not enrolled on a clinical trial (called routine or standard care) may still be billed to you or your insurance provider and have out or pocket costs. In some clinical trials, volunteers are compensated for their time and travel commitments.

No, Clinical trials have standards outlining who can participate. Some studies require people who are healthy, not taking any medications, are over age 18 and some studies are limited to a predetermined group of people who are asked by researchers to enroll.

Other studies may require people who have existing medical conditions that will be studied such as diabetes, high cholesterol, COPD or other conditions, and/or people who are taking certain medications.

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.

Choosing whether or not to participate in a clinical trial is a decision that millions of individuals make each year. Before making that decision, it is important to learn about clinical trials and what it means to be a study participant. The frequently asked questions below help you learn about and what to consider before taking part in a trial.

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective?
• Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working?
• Will results of the trials be provided to me?

Who will be in charge of my care?

Additional resources for information and frequently asked questions about clinical trials for patients and their families can be found at:

• www.clinicaltrials.gov/ct2/about-studies/learn

These links are very useful to others who might not be able to find a trial within our facilities as they will connect them to sites where other trials are listed across the nation. Might be beneficial to our potential participants to have these links imbedded somewhere on our site.

www.centerwatch.com
www.cancer.gov
rarediseases.info.nih.gov
www.acrpnet.org
www.coronaclinicaltrials.com