Since the earliest days of the presentation of COVID-19, it was generally assumed that children were less at risk for infection than adults. Recent data shows that this may not be the case. In fact, in October, alone, children accounted for 200,000 of the new cases of COVID-19 being reported. With recent data suggesting the majority of new cases have been coming from the ‘young adult’ population, it now appears that there may be cause for concern that this population may not just be transmitting the virus to the elderly, but to their own children, as well. This supposition is supported by a recent study conducted in North Carolina which found that 77% of children and adolescents who lived with a household member who was infected with the SARS-CoV-2 virus had a positive COVID-19 RT/PCR test. Possible reasons for the increased risk of infection where having an infected sibling or Hispanic ethnicity. Interestingly, asthma was associated with a lower risk. Also of interest is a study conducted in New York of children and adults with COVID-19 that revealed that there where different antibody responses between the adult and pediatric populations.
An ethics committee must review each study before it is allowed to begin. It is known as the Institutional Review Board, or IRB. The committee is comprised of doctors, nurses, and people from the community who review the studies in order to protect the participants’ rights and safety. In addition, the Food and Drug Administration sets specific requirements for drug testing that are followed in every study.
Clinical research studies can lead to the advancement of medical therapies to treat and help individuals around the globe with all different health conditions. You can assist in leading the medical industry as a participant in clinical research and also receive top medical advice and care at potentially no cost to you.
The informed consent is a process that takes place before you can join the study. During this process, you will be told what you can expect from the study. You will be told who will seek your personal medical information, and how it will be kept confidential. A consent form will also be given to you to read. You are encouraged to ask questions both about the study and parts of the consent form that are unclear to you. If you decide that you would like to be part of the study, you will be asked to sign the consent form. However, even after signing the consent form, you are allowed to change your mind and withdraw from the study at any time.
Each study has different requirements that pertain to the volunteers. Age groups can differ and certain diseases or histories of diseases are not allowed while other specific diseases are sometimes required. If you are interested in volunteering for a study, our research team will gather information from you on your medical history in order to find out if you qualify for the study. You will also be told of the possible risks and benefits that come with being involved in the study through the informed consent process.
A research team made up of many different employees run the actual clinical studies. The head of our team is Dr. Isaac Melamed. He is also known as the Principle Investigator of the studies. The Sub-Investigators are doctors and physician assistants. And finally, there are multiple coordinators who handle most of the administrative responsibilities of the clinical trial, act as a liaison between the office and the sponsor, and review all of the data records. Each person plays a critical role in completing the studies.
Clinical research studies are sponsored by government agencies and private organizations in an attempt to find better ways to treat diseases. Pharmaceutical companies working with medical centers, doctors’ offices, and the government sponsor studies to test their products.
As one of the top research centers for immune related clinical trials, we are dedicated to providing our patients with the highest standard of care. Our team ensures that each and every patient is able to experience the best of IMMUNOe’s expertise and passion. Our goal is to make you feel as comfortable and prepared as possible for your appointments. In order to maximize your comfort, we invite you to familiarize yourself with how we operate and what to expect as a study volunteer at IMMUNOe. You may be wondering if you should volunteer. No doubt you have questions as to who sponsors these clinical trials, who is protecting your rights? Clinical trials are research studies that deliver new life changing drugs — but they can’t happen without clinical trial participants. 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. You may find answers to some, if not all, of your questions below. If, for any reason, you have more questions or would like more information, please feel free to call our research staff at 303.771.9000.