Dr. Kore Kai Liow is a board certified neurologist with over 15 years of clinical research experience. He has personally served as the PI for over 60 Phase I-IV neuroscience clinical trials. His research has been published in over 40 peer reviewed publications and has received the “Honolulu Top Doctors” award in 2015, 2016 and 2017.
What are Clinical Trials?
Clinical trials are controlled research studies that monitor the safety and effectiveness of medical treatments or devices for human use. Clinical trials involve many different aspects of research. Some trials test new, cutting edge medications, while others test new combinations or applications of medications that have not been previously approved. All trials, however, require the participation of volunteers in order to advance medicine as a whole. The volunteers are medical heroes!
Will I Be A Guinea Pig?
A common myth about clinical trials is that participants are research “guinea pigs.” This statement could not be further from the truth. The myth stems from how guinea pigs were used in research because of similarities they share with humans. However, guinea pigs do not have the ability to understand what a clinical trial involves and sign an informed consent. An informed consent form is a document that describes the goal of the study, what risk is involved, the possible benefits to the patient, and potential patient compensation. As mentioned above, all clinical trials are monitored by IRBs that ensure the trials are ethical and as safe as possible for human participation. Research volunteers are not guinea pigs. However, participants are just as important to future medical breakthroughs as guinea pigs were to the discovery of the tuberculosis vaccine!
Are Clinical Trials Safe?
The biggest concern we encounter from our patients is the safety of their participation. However, our team of doctors, and study coordinators monitor your health very closely and will support you throughout the clinical trial process. All pharmaceutical research goes through an exhaustive preclinical testing process before it is approved to be tested in the clinic. Additionally, every clinical trial in the United States is monitored by an Institutional Review Board (IRB) and must pass their regulations in order to ensure the trial is as safe and effective to the participants.
All pharmaceutical research goes through an extensive preclinical testing process before it ever reaches human patients to make sure it is as safe and effective as possible. Every clinical trial in the US must pass rigorous regulations and be monitored by an Institutional Review Board (IRB) to ensure the risks of the trial are as minimal as possible and worthy of any possible benefits to the participant. All research participants are volunteers and can opt out of a trial at any given point.
How Do I Benefit From a Clinical Trial?
There are numerous benefits from participating in a clinical trial. Many of our participants appreciate the access to cutting edge treatments that are not available. Others participate to receive potentially expensive study medications and treatments at no cost, as well as compensation for their time and travel. Lastly, our patients love the sense of community and the kokua (civic duty) they feel knowing that their participation contributed to the advancement of medicine.
What are the Phases of a Clinical Trial?
Clinical trials are divided into 4 different phases. The earliest phase trials look at whether a drug is safe or the side effects it causes. Later phase trials aim to test whether the new treatment is better than existing treatments.
Phase I involves the testing of IP’s (investigational products) for safety in humans for the first time. Phase I trials typically involve a small number of either healthy volunteers or people with the disease/condition.
Phase II trials continue to monitor the safety of the IP and determine its effective dose. These trials involve several hundred volunteers.
Phase III trials measure the effectiveness of the IP to treat a designated condition. These trials are large scale and involve hundreds to thousands of volunteers.
Phase IV trials are often required by the FDA and are designed to measure long term safety and efficacy of IP’s after they are approved.
Who Pays for this Research?
Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grant provides the funding to conduct the study at local research sites, so participants don’t pay a thing. In fact, we don’t even ask for your insurance information.
How Long Is A Clinical Trial?
Depending on the trial, our projects range from 3 months to 8 years. Each program is unique to its treatment and participants will know in detail how long the study is expected to last.
How Do I Know If I am Qualified?
Since each research program is unique and has its own set of enrollment criteria, the best way to find out if you qualify for a clinical research study is to call us and come in for a free screening evaluation. Whether you have a pre-existing medical condition and want to explore research solutions, or you simply want more information, come visit our CRC and find out more. Our research staff are more than happy to personally meet with you and serve you.