LC Rheumatology Research
LCR Research is a division of LC Rheumatology, PLLC which was founded in 2009 with the mission to provide much-needed care to patients suffering from rheumatologic and auto-immune disorders.
Our specialists work with your primary care physician to diagnose and treat problems which affect rheumatology and immune system issues.
Our team of board-certified physicians are widely recognized as the region’s experts and bring advanced training, a wealth of experience, and a commitment to collaboration to this vital subspecialty of rheumatologic medicine.
When it comes to continual progress and generating new ideas, research is a paramount element to success, approval, and eventually, relief for those affected by certain medical conditions. All of the medical procedures and treatments that we’re able to offer today are the result of medical research, but we don’t want to stop there.
At LC Rheumatology, our goal is to keep moving forward and expand our ability to serve the communities and provide a higher quality of life for those who struggle with rheumatologic and auto-immune disorders. New treatments and innovative approaches are achievable with committed exploration and research; LC Rheumatology seeks to bring these solutions to life and to the people and communities that are counting on us.
We’ve dedicated our focus to our first line of offense: clinical trials.
What are Clinical Trials?
Clinical trials, also known as clinical studies, involve the willing participation of volunteers in studies conducted by experts and doctors in medical fields in order to determine the effectiveness of new drugs, treatments, procedures, and approaches. In these trials, we’re able to compare the benefits of the new product or procedure to the effectiveness of pre-existing approaches or to a sample group that receives no treatment.
Clinical trials are often sponsored or funded by pharmaceutical companies, physician initiated, or federal agencies – such as the National Institute of Health or the Department of Veteran Affairs – that have an investment in the targeted demographic that would benefit from the new approach.
Why Would Someone Volunteer to Take Part in a Clinical Trial?
When it comes to relief – especially for conditions that don’t have many existing treatment options – participation in clinical trials provides the opportunity to find relief in a new way. Benefits of participating in clinical research trials include:
- Being involved in the process of identifying new, more effective treatments
- Being one of the first to gain access to a new, potentially-effective treatment
- Having the knowledge that you played a part in pioneering a treatment that would make a positive and lasting difference for countless others seeking relief
- Receiving a small participation stipend or the ability to receive treatment at little to no cost
- Having the cost of all lab work, doctor visits, medications, and supplies waived since research trials are typically covered by the company, individual, or organization sponsoring the study
How a Clinical Study Works
Establishing an Idea
Clinical studies all begin as ideas that are presented and studied extensively in a laboratory. After researchers test new therapies, drugs, and procedures by conducting the necessary preliminary non-human studies, those approaches with promising results move into clinical trials to gather additional information about the risks and effectiveness.
Designing the Protocol
To ensure the health of participants, every clinical trial has a protocol plan in place to answer specific, research-related questions and define the boundaries of the study. This protocol outlines:
- Who is eligible to participate in the trial
- Specific details of what the trial will entail, including any:
- Tests
- Medications
- Procedures
- Dosages
- How long the study will last
- The information will be gathered
Phases of a Clinical Trial
Please note that LC Rheumatology Research only conducts Phase II-IV trials
Phase I
The first phase of a clinical study is performed on a smaller scale with a small group of 20-80 people. The goal of Phase I is to evaluate the safety of the new approach and identify any side effects that develop. LC Rheumatology does not conduct this phase of clinical trials.
Phase II
The second phase of a clinical study is performed with a larger group of 100-300 people when a clear set of side effects has been established. The goal of Phase II is to initially determine the overall effectiveness of the new drug, procedure, or treatment and to further evaluate safety.
Phase III
The third phase of a clinical study is performed on the largest scale, administered to groups of volunteers that number approximately 1,000-3,000 people. The goal of Phase III is to conclusively determine the level of effectiveness, monitor the established side effects, compare the new approach with other treatments, and collect any information that will allow it to be used safely on a public scale, which is the final phase.
Phase IV
After the drug, treatment, or procedure has gained FDA approval and has been released to the public, our researchers continue to track its use in order to learn more about potential risks, benefits, and optimal use.
Our Promised Participant Safety
LC Rheumatology takes our participants’ safety very seriously, which is why we have safeguards in place outside of the provided trial protocol.
The Team
In our clinical studies, we have a research team that employs a principal investigator (PI), who is typically a doctor but can also be nurse practitioner. While qualified members of the research team regularly evaluate the participant’s health for the sake of assessing the study’s safety and effectiveness, the PI ensures that the utmost safety and care is taken when it comes to the participants.
IRB Review
US clinical trials are approved and monitored by an Institutional Review Board, or IRB. IRBs are usually made up of a mix of physicians, statisticians, and community members to ensure ethical trials and protected participants.
This board is formally designated by the FDA and oversees trials to ensure that risks are minimal and worth any potential benefits. It also has the authority to approve, require modifications to obtain approval, or disapprove research in order to guard the rights and safety of participants.
Informed Consent
We always ensure that our participants volunteer with informed consent. Informed consent means that we provide our potential participants with all of the critical facts about a clinical trial before they decide whether or not to participate so that they are aware of what they are consenting to. This process of informed consent continues throughout the study, especially when additional information is provided as it becomes available.
We like to stress that informed consent is not a contract. Volunteers may decide to withdraw from the study completely or to refuse particular treatments or tests at any time. This may make them ineligible to continue the study, but withdrawing from the study does not affect the patient’s day-to-day routine care should they be a patient with LC Rheumatology.
Before a participant volunteers for a trial:
- Members of the research team will explain the details of the study
- The potential participant will be provided with an informed consent document, which includes all details of the study. This covers:
- The purpose of the study
- How long it is expected to last
- What procedures will be required
- Risks
- Potential benefits
- How to obtain additional information
- Any other important information
Once this process is complete, the potential participant is free to decide whether to sign the document and take part in the study or not.
Interested in LC Rheumatology Research?
If you would like more information about any of our studies or would like to be considered for future studies, please contact Deb Walker at dwalker@lcrheumatology.com or by calling (502) 351-6983.
