Get to Know More About Clinical Research Studies
Patient knowledge is key to successful studies. This section introduces several conditions commonly under research investigation, why clinical research trial are important, followed by Frequently Asked Questions related to a patient and what can be expected.
Know the Conditions: Understanding the Symptoms, Causes, and Treatment Options
The following are basic-general overviews of conditions commonly within clinical trials. Please Note: These descriptions are in no way meant to provide expert medical advice. Patients should always consult their medical professionals about any condition which they may experience or require details to their specific case.
Why Clinical Research Studies Are Important:
A clinical research study is a scientific investigation that involves testing the safety, efficacy, and/or effectiveness of medical treatments, devices, or interventions in humans. The purpose of a clinical research study is to collect data and evaluate the outcomes of these interventions in order to determine their safety and effectiveness.
Advance Medical Knowledge
Help to expand our understanding of diseases, treatments, and interventions. Studies provide a way for researchers to test new ideas and treatments, and to gather data that can be used to develop new drugs, devices, and therapies.
Improving Patient Outcomes
Designed to help improve patient outcomes. Studies provide important information about the safety and effectiveness of medical treatments and interventions, which can help healthcare providers make better decisions about how to treat their patients.
Promoting Evidence-Based Medicine
Provide important evidence that can be used to develop evidence-based medicine. This means that healthcare providers can use the most up-to-date information to make decisions about patient care.
Ensuring Patient Safety
Carefully designed and monitored to ensure that the safety and well-being of participants is protected. This includes monitoring for adverse effects and taking steps to minimize any risks associated with the study.
What are clinical trials?
Clinical trials look to uncover the causes and treatment methods regarding various medical conditions and diseases. The typical goals of a trial can include understanding prevention, early detection and/or treatment methods. Introductory drugs and combinations of current drugs, or medical procedures may be involved, while ensuring these are safe and effective for humans. Ultimately, these studies help researchers to discover better treatments and offer hope to improving the quality of life for individuals with acute or chronic conditions.
Why do individuals participate in clinical trials?
Participation in clinical trials can be for various personal reasons. In many instances, participating individuals are looking to access leading-edge research and treatment methods for conditions that they experience. Other individuals simply want to assist with the identifications and cures so they or a family member may benefit in the future.
What are the benefits from participation in a clinical trial?
Benefits are specific to the individual involved. The common reported benefits are access to specialists, care, and leading-edge treatment innovations.
Where will the clinical trials be performed?
Entering the participant’s home zip code during the enrollment process allows the Omni Clinical solution to identify both remote trials and those that may be within their local area, usually within 25 miles. In some instance, a trail may take place a further distance. The participant should decide if distance is a key criterion. Note: Some trials may reimburse for additional travel expenses, so this should be asked.
Will there be compensation offered for participating in a clinical trial?
Clinical trials do typically offer compensation to individuals who participate within their trials. Compensations vary by study. Compensation can be set dollar amounts per participant, and/or time and travel expense reimbursements. Most all trials also provided no-cost study-related care (including labs) and medications during the clinical trial period. Specific compensation details are provided to participants prior to being accepted into the trails. Note: Medical insurance is not required to participate.
Will the participant’s current healthcare be affected?
No. During the clinical trial period, the participant will continue to visit their primary care doctor as normal for health issues not related to the clinical trial. The participant’s primary care doctor will receive updates on the participant’s progress. In some cases, the participant’s doctor many be directly involved with the trial.
What about current medications being taken?
In most cases, the clinical trial will not require a participant to stop or replace any of their current medications. In all cases, current medications will be reviewed by the clinical trial staff. Any changes will be discussed with the participant’s prescribing doctor.
What should an individual know before participating in a clinical trial?
Individuals may have several questions regarding the participation in a clinical trial, especially if never having experienced the process previously. Information such as: What is the purpose of the trial? -- How will the clinical trial be conducted? -- What is expected from the participant? -- How long will the trial last? are just a few. Individuals considering participating in trails will have the opportunity to discuss these and other questions with the staff conducting the specific clinical trials. To learn more about clinical trials and the rights of participants, please visit the National Institutes of Health (NIH) website at https://www.nih.gov and search for "clinical trials".
How safe are clinical trials
Clinical trials must adhere to strict rules and regulations established and monitored by the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA). NIH is responsible for biomedical and public health studies, while FDA is responsible for new medications. Clinical staff members associated with the specific trials will discuss the procedures and benefits/risks prior to any participant agreeing to partake within a trial.
Is a participant’s information kept private and confidential?
Participant personal data is strictly confidential and secure. More information can be found within the Privacy Policy Statement found on this site. In addition, privacy policy statements specific to the individual clinical trial will also be available with the trial.
How long does a clinical trial usually last?
Each clinical trial can vary depending on the actual study or program, ranging from a few weeks to multiple years. The duration of the specific trial will be discussed as part of the participation enrollment process.
What happens if a participant needs to or desires to leave a clinical trial?
Any individual looking to no longer participate within a trial should always consult with the clinical trials staff and their primary care doctor before leaving.
What happens at the end of a clinical trial?
Each clinical trial ending can vary based on the specific trial. In most all trials, the collected data is reviewed and analyzed by the organizations requesting and conducting the trial. The results are typically published within associated medical journals and other media resources. Study results found to offer safe and effective benefits are often shared as new practices/medications, as appropriate.
How can I learn about upcoming trails?
New clinical trials are always being announced. Individuals can continue to visit this site on regular basis, entering their local zip code, where appropriate trials will then be displayed. In addition, individuals can receive messages from Omni Clinical auto-notifying them of new available trials matching the participant’s needs.
Where can an individual lean more about clinical trials?
Individuals can learn more about clinical trials and an individual’s rights as a participant in a clinical trial by visiting https://www.nih.gov and searching "clinical trials".