Clinical Trials – What They Are, Why They’re Important and How You Can Participate
Research is critical to learning more about disease and potential treatments. While research is important, the different types of research can be confusing and even overwhelming. In the coming months, we will be writing a series of blogs to provide you with more information about research – if you have any questions or would like us to cover a specific topic, please post in the comments section at the end of this blog.
What are clinical trials?
Clinical trials are research studies that investigate the safety and effectiveness of a medical treatment, strategy or device. A clinical trial is often used to determine if a new medical treatment is more effective or has less dangerous side effects than the standard treatment used. The main types of clinical trials are interventional (testing the safety of a drug, device or new treatment) and observational (observing participants over time). Clinical trials also consist of different phases which first test the safety of a potential new treatment and then progress to larger scale research.
Why are clinical trials important?
Clinical trials are meant to answer unknown medical questions with the goal of improving the health and quality of life for patients. They can lead to the discovery of safe and effective therapies and contribute to the advancement of research towards cures. For people with COPD, clinical trials are crucial in order to find better treatments, new drugs and medical devices that can improve their quality of life.
Clinical trials also play a crucial role in the drug and medical device approval process. The Food and Drug Administration (FDA), a Department of Health and Human Services agency that approves new treatments or devices before becoming available to the public. Before a treatment or device can be approved by the FDA, clinical trials gather the data needed that can affect the FDA’s decision.
Why volunteer for clinical trials?
Clinical trials are crucial for medical breakthroughs and finding better treatments and devices to make people’s lives better, including COPD patients. Study volunteers play a critical role in this research process and are needed for successful clinical trials – recruiting for clinical trials is very difficult and slows down the research process. Through clinical trials, research participants might receive certain benefits such as regular monitoring by trained medical professionals and have access to new disease treatments that could possibly work better that what is currently available. Clinical research could be right for you if you’d like to be part of a medical breakthrough that may help others, including your current and future family members. How is your safety and privacy protected in a clinical trial?
Congress has put laws in place to protect the safety and privacy of clinical trial participants. These laws require researchers to follow strict guidelines to ensure the safety of participants and every clinical trial must follow a careful study plan or protocol that describes what the researchers will be doing during the trial. All clinical trials must be approved by an Institutional Review Board (IRB) that is comprised of doctors, scientists and everyday people. The IRB is tasked with making sure that the study participants are not exposed to any unnecessary risks. Before joining any clinical trial, you will be told what to expect as a study participant as well as all the things that could possibly happen during the trial. After learning all the information, you can decide whether you want to participate. The consent form is not a contract and you can leave the trial at any time, for any reason without being put in a difficult position regarding your medical care as researchers must keep all health and personal information private.
Where can you find information on clinical trials?
If you are interested in participating in clinical trials, there are several ways you can learn about new trials and also other types of research studies. A few of these avenues include, asking your doctor about research opportunities, searching for studies on www.clinicaltrials.gov and joining research registries. A research registry is a type of research where information is collected from participants who share a common risk factor or are diagnosed with a disease. Individuals who participate in research registries are often notified about opportunities to participate in clinical research for which they might be eligible.
The COPD Foundation has established a research registry, the COPD Patient-Powered Research Network (PPRN), which is open to COPD patients and those who are at risk of developing COPD. By enrolling, participants agree to share their health information and be contacted about research opportunities, including clinical trials. COPD PPRN participants are not automatically enrolled in any clinical trial or study without permission; they are just offered the opportunity to participate if eligible and interested. Learn more about the COPD PPRN here.