About Clinical Trials
Clinical research trials play a critical role in advancing our medical understanding in bringing new treatments to the general public. Most people do not stop to consider how medical treatments come to market and the process by which they must qualify and provide satisfactory evidence of safety and efficacy before they’re made available to doctors and clinics. Clinical trials are a key component in that process.
Participation in clinical trials is by volunteer only. Individuals considering enrolling in a clinical trial should have an open mind and know the trial’s purpose and requirements before deciding to apply. When inquiring about a study, for those that meet the basic pre-qualifications, you are provided an informed consent form detailing the study process, potential risks, timelines, your rights as a participant, and compensation for the study.
There are benefits to participants for volunteering for a clinical trial. Participants are never expected to pay for any study related treatment while on the study, in fact, most studies offer a time and travel compensation. Participants often get free physical exams and labs done by a board-certified doctor who’s involved in the investigation on the particular trial. Also, know that some studies are on already FDA approved drugs, and the trial is to test the safety and efficacy of new dosing regiments, intervals, or its use in combination with other medications.
Ultimately, because new medications and treatments are vetted so thoroughly, and with a high degree of scientific research, we can be encouraged that medications on the market are safe and effective. The individuals who participate in these studies are the heroes helping improve the lives of Americans and others around the world.
For new medications, procedures, or devices to obtain FDA approval, they must go through a thorough research process. The clinical trial is a stage of research whereby a select number of individuals volunteer to participate in a study of the new medications, procedures, or devices. There are various phases which start with a very small test groups of healthy people and then scales up as the research study provides positive results for safety and efficacy. The researchers collect data related to the study which gets compiled to evaluate the safety and efficacy of the test medication, procedure, or device.
Each study provides a detailed plan for the investigators to follow regarding the specific factors that a patient must satisfy and determinants which they must not satisfy to qualify for the study. These lists are referred to as the “Inclusion” and “Exclusion” criteria. These factors can range from demographic data, such as age, race, and gender; to medical histories such as other current medical conditions, previously diagnosed conditions, and prior or current medications. The process of qualifying for a study is called Screening.
There are many reasons why individuals participate in clinical trials. Many enroll because the available treatments did not meet their needs. Volunteers also gain early access to potential new treatment options and medications. Some participants enroll because their insurance will not cover the treatment they need. Others enroll for more altruistic reasons, such as helping provide important data to the medical community as researchers work to cure diseases and conditions which may affect their children and grandchildren. Regardless of the reason, STAT Research is dedicated to making sure our volunteer patients are respected, informed, and well cared for.
For a person to qualify for a study they must go through the screening process to ensure they meet the study requirements. Some screening can be done by a web-based form, or a short phone call (typically called a pre-screen). If you pass the pre-screen you will typically be asked to have a screening visit with the investigating doctor and study coordinator. A screening visit may include lab work, x-rays, and other assessments to ensure you fully meet the requirements. As with any phase of a clinical trial, there is no cost or obligation to volunteers.
Participants get paid for each completed visit, including the screening visits, regardless of whether or not you ultimately qualify for the study.
Our policy at STAT Research is that each participant receives the predefined visit payment, at the end of each completed visit. This includes visits which are unscheduled, for example, if a lab needs to be redrawn, you will be paid for coming into the office for that visit as well. Our payment methods include direct deposit (2-business days) or paper check. Unfortunately, we cannot provide cash due to the limitation of tracking our payments for ethics compliance.
YES! Research patients may choose to leave a clinical research trial at any time. The research team will work with you in returning unused medications, performing final safety assessments, and we will follow-up afterward to ensure you remain in good health.
Research study participants data is reported anonymously, through what is referred to as a randomization number. Any identifying information, such as your name, address, or birthday is always removed from documents shared with the research sponsor, and replaced with your randomization number. The sponsor will only be provided general details, such as your race, sex, and age.
This section is only to provide you with a small bit of information regarding clinical research trials. We recommend you do your own research to help decide if enrolling in a research study is right for you.
If you still have questions, please give us a call, we’re glad to help!
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Feel free to contact us using the form below. We’ll be glad to answer your questions regarding potential participation in a study.