Clinical Trials for Patients

Clinical trials are an important part of furthering medical research because they investigate how diseases affect patients and also test the safety and effectiveness of new drugs and treatments. There are many clinical trials that take place in the United States every year. If you are interested in learning about or participating in a clinical trial, read the basic questions and answers below.

What are clinical trials?

Clinical trials are research studies with volunteer patients that investigate complicated health-related questions. Some trials study how different diseases affect patients in natural settings and other trials explore the safety and effectiveness of drugs or therapies used to treat patients with a specific disease. These two types of studies are called observational trials (those which observe patients in natural settings) and interventional trials (those which test drugs and new types of treatments).

Why are clinical trials important?

Clinical trials are important to make sure drugs and treatments are safe for patients and effective at treating specific diseases and symptoms. This knowledge comes from studying the information and data that is gathered over the course of one or several clinical trials which test a type of drug or treatment. The results and conclusions about what happened during the study can then help doctors make informed decisions about the effectiveness and safety of the drugs and treatments which they recommend to patients. Without accurate information from clinical trials, new forms of treatment and new drugs would not become available for patients.

What types of patients can participate in clinical trials?

Many different kinds of patients and healthy individuals can participate in clinical trials, but each trial lists who can and who cannot participate. These requirements are outlined in detail by the researchers and doctors conducting the study under the Eligibility section of a study’s description. Patients who do not meet all requirements will not be able to participate in the study.

How can I participate in a clinical trial?

To find out if you are able to participate in a clinical trial, discuss your condition and all potential treatment options with your doctor or healthcare professional. Often times your doctor may be aware of clinical trials which are being conducted at nearby hospitals and universities. There are many ongoing clinical trials across the country and throughout the world, but they may only be looking for local candidates. Each clinical trial strictly defines who can participate in the Eligibility section of the trial’s description.

Is it safe to participate in a clinical trial?

Clinical trials undergo careful review and adhere to strict ethical and legal codes to maximize benefits and minimize potential risks. Participation is strictly voluntary and consent outlining the potential risks and benefits is required prior to enrolling in a clinical trial.

There are general benefits to participating in clinical trials, because it allows patients to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

There are general risks for patients participating in a clinical trial.

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The clinical trial may require more time and attention than standard treatment, including more trips to the study site, more treatments, longer hospital stays or complex dosage requirements.

How do I know if a clinical trial is right for me?

Firstly, it is important to discuss the possibility of participating in a clinical trial with your doctor. He or she has the best understanding of your current medical needs and can discuss the benefits and risks which relate directly to you. Your doctor may also be able to recommend clinical trials that are being conducted in your area.

Once you have found a clinical trial in which you are eligible to participate, it is important to learn about the details of the study. Researchers are ethically and legally required to explain these details in writing and answer all of your questions in person. Informed consent is the process of describing the research procedures, risks, potential benefits and other relevant information to allow patients to decide whether to participate in the research. Many patients take this information home to read and share with family members before deciding to participate in a clinical trial. If a patient has additional questions, researchers are expected to make themselves available to discuss the concerns.

How do I agree to participate in a clinical trial?

Once all the details of the clinical trial have been explained to you, signing an informed consent document verifies that all your questions have been answered and that you agree to participate in the research voluntarily. Voluntary patient participation is an essential part of ethical medical research.

It is important to understand that signing an informed consent document does not require you to continue in the study if at any time you no longer wish to participate. Additionally, if a patient decides to stop participating in the study, the researchers must ensure their medical needs are met and must facilitate their further care.

How can I learn more about clinical trials?

Your doctor may be an excellent resource for advice regarding clinical trials. The federal government’s website, www.clinicaltrials.gov, is also a great resource which allows patients to search for ongoing clinical trials and provides a great deal of general information about clinical trials as well. We recommend you use the links provided in the box above when searching for specific clinical trials related to anemia.