Clinical Trials and Research Studies
Clinical trials are research studies conducted with the help of participants who suffer from the same medical condition or disease. The purpose of clinical trials is to further the medical communities’ learnings around specific medical strategies, medication, medical devices and treatment plans in order to determine the best path forward. Clinical trials follow strict scientific structure in order to ensure the data that is captured is unbiased.
Participate in a Clinical Research Study
Clinical trials move medicine forward.
Why Become Part of a Clinical Trial?
Participating in clinical trials helps to improve the standards of care for future patients. Key benefits to participants include gaining access to cutting edge treatment options not yet widely available, as well as a more participatory treatment experience, where in many cases, the support of an entire team of healthcare providers is readily available.
Your participation in research studies and clinical trials is always voluntary. You have the right to ask questions, and we encourage all patients considering this option to discuss it with their families, friends and current healthcare providers. If a decision is made to participate in a clinical trial, you will be asked to sign a consent form. You may withdraw your consent at any time without affecting your care. All personal study information will be kept confidential.
How Clinical Trials Work
Each new clinical trial that we conduct is built on a master plan, known as a protocol. This plan describes in detail how the trial will work. Each clinical trial is led by a principal investigator(PI), who is responsible for preparing the protocol. Each medical facility or clinic that takes part in the clinical trial uses the same protocol, to ensure consistency in results.
Key information in a clinical trial protocol includes:
- how many patients will take part in the clinical trial
- who is eligible to take part in the clinical trial
- what tests patients will get and how often they will get them
- what type of data will be collected during the clinical trial
- detailed information about the treatment plan
A clinical trial’s protocol describes what types of patients are able to take part in the research. Each trial must include only people who fit the patient traits for that study (the eligibility criteria).
Eligibility criteria differ from trial to trial. They include factors such as a patient’s age and gender, the type and stage of disease, and whether the patient has had certain treatments or has other health problems which may factor into results.
Clinical Trial Phases
Clinical Trials for new medicines or medical devices are done in phases. Each phase serves a unique purpose, and helps answer specific questions.
In most clinical trials, the protocol will require patients to be divided into comparison groups. Each comparison group will receive a different medical strategy in order to compare and evaluate approaches to care.
Are Clinical Trials Safe?
Many people who have not previously participated in a clinical trial are concerned about the safety of participating. The safety of our volunteers is our number one concern! While participating in a clinical trial you have constant access to medical care and qualified staff who monitor your well-being with meticulous attention to detail. Our doctors, nurses, and study coordinators will support you throughout the clinical trial process.
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.
How Do Patients Benefit From Participating in Clinical Trials?
There are numerous benefits from participating in a clinical trial. Many of our volunteers appreciate the access to cutting edge treatments. 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 civic service they feel knowing that their participation contributed to advancement of medicine.
Who Pays For This Research?
Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grants provide the funding to conduct the study at local research sites, so you don’t pay a thing. In fact, we don’t even ask for your insurance information.
How Long Do Programs Last?
Depending on the type of research, studies can last from a few weeks to several years. Each program is designed to collect specific information, but volunteers will know before enrollment how long the study is expected to last and exactly how many visits to the research site will be required.
How Do I Know If I Qualify To Participate?
Because each research program is unique and has specific enrollment criteria, the best way to find out if you qualify for a clinical research study is to either call us or come in for a free evaluation. Whether you have a medical issue and want to explore research solutions or you are a healthy volunteer, come visit one of our research sites and find out more. There is never an obligation, and one of our experts will be happy serve you.