What Is A Clinical Research Trial?
A clinical research trial is a carefully designed study involving volunteer patients who receive treatment under the supervision of qualified medical doctors. These highly qualified investigators participate in clinical trials in order to determine whether new medications, treatments, devices, or new ways of using known medications, treatments or devices are safe and effective. We have been conducting clinical research trials for more than 12 years at Carolina Urologic Research Center (CURC).
Participating in a clinical trial is different from being treated as a routine clinic patient. Clinical research trial participants are monitored very closely by their physicians, clinical research coordinators, and the trial sponsors (Data only, as no personal information is ever given to study sponsors). We have found that research participants appreciate the special time and attention they receive at CURC. Our participants are treated like family, and patient safety is always our top priority!
It’s important to keep in mind that research trials are done because researchers want to answer scientific questions in order to advance medical knowledge. The answers may offer benefits to society and to future patients, but it is important to understand that you, as an individual research subject, may or may not benefit from participating in a trial.
For more detailed information about what it means to participate in a clinical trial, please visit the National Institutes of Health/NIH Clinical Research Trials and You at: http://www.nih.gov/health/clinicaltrials/index.htm.
Why Should I Participate In A Trial?
Most medications, devices and treatments exist today as a result of past clinical research trials. Clinical research gives healthcare professionals a better understanding of diseases, improves existing treatment methods, and allows for the advancement of medical care for our future generations. Clinical research trials give patients an opportunity to take an active role in their health care. Many clinical research trials are often available for those patients who have exhausted all traditional treatment options as well.
Where And How Are Clinical Trials Performed?
Clinical trials are conducted at Carolina Urological Research Center (CURC) under the supervision of one of our five clinical investigators, clinical research coordinators (5 RN’s, and 2 bachelor’s prepared coordinators), and supportive staff. The duration of all of our clinical research trials vary from one visit to several years. Potential trial participants should consider their proximity to our Myrtle Beach, South Carolina location.
The “rules” for each individual clinical research trial are detailed in a protocol. It is important that study participants help the clinical research staff follow the protocol as closely as possible. Our staff will carefully explain the requirements of a particular protocol, and an informed consent process will be completed prior to performing study-specific procedures. Potential study participants are encouraged to read the informed consent form (ICF) in full, and to discuss the trial with anyone that they choose to share the information with. Potential research participants are allowed to take as much time as is needed to decide to participate or not. Clinical research trial participants are required to sign the ICF in the presence of a designated clinical research staff member, and they will be given a copy of the ICF for their records. It is important for a clinical research trial participant to know that they may withdraw from the study at any time, and their care will continue as per standard of care. If a study participant chooses to withdraw from a trial earlier than expected, it should be thoroughly discussed with your physician first, to ensure a safe study exit.
You can review a very short summary of our trials here on our website under “Current Trials,” or you can read a more detailed version of each trial by visiting http://clinicaltrials.gov/.
What Is Included In An “Informed Consent Form (ICF)?”
An informed consent form (ICF) may include (but is not limited to):
- Study title/number
- Study sponsor and funding information
- Name of the Principle Investigator of your site
- Telephone numbers (24-hour coverage)
- Study introduction and background
- The purpose of the study and number of expected participants
- Study visit procedures and duration
- What happens when the trial has been completed
- Possible risks associated with the study
- Unanticipated side effects
- Possible benefits associated with the study
- Protection of your personal information and confidentiality
- Whether a stipend (payment to help with travel costs) is provided or not
- Whether there are any associated costs that you will be responsible for
- Your rights as a study participant
- Whether you want a primary physician to be notified of your participation
- Who you can contact if you have questions about the study
- Designated signature and date spaces
*All of CURC’s Informed Consent Forms are pre-approved and stamped as such by the study’s specific IRB (Institutional Review Board) prior to enrollment.
How Long Will My Study Last? / What Do The “Phases” Mean?
Each study has different requirements and different duration lengths and the process is based on the type of trial being conducted. A clinical trial can be categorized as falling into one of four stages or “phases”.
Phase 1 studies are designed to evaluate safety and effectiveness of a compound in humans. Any and all of the side effects (sometimes during dose escalation) are recorded. Usually, healthy participants are enrolled in Phase 1 studies; however, participants with the disease being studied may under certain circumstances be enrolled. The total number of participants included in Phase 1 studies varies with the drug, but is generally in the range of 20-80.
In Phase 2 studies, treatment is given to patients with the disease or condition to be treated, diagnosed, or prevented. During Phase 2, safety and effectiveness data is collected, as well as side effects, and additional information about the proper dose and dosing schedule. Phase 2 studies typically involve control groups, are closely monitored, and are usually conducted in groups of not more than several hundred participants.
Phase 3 studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit/risk relationship of the drug. At the conclusion of a properly designed Phase 3 trial, the new drug will be found to be inferior, equivalent, or superior to the standard treatment. This is the phase when the product will be approved or rejected by the U.S. Food and Drug Administration (US FDA).
Phase 4 studies are also known as “post-marketing” studies. In this phase, researchers gather additional information about the long-term safety and effectiveness of products that have received FDA approval. These studies can also include trials of different doses or schedules of dosing, dosing during other stages of disease, cost studies, quality-of-life studies, or studies in the use of the drug over a longer period of time.
How Much Does It Cost To Participate In Trials?
Costs covered can vary by study. In many clinical studies, qualified participants will receive the study product, required labs and procedures, physical exams and education at no charge. Subjects may also receive compensation for their time and travel expenses. These rates vary per study. The Informed Consent Form for each study details this information. You may also ask the study staff if you have any questions, concerns, or special circumstances that need to be considered.
Do I Need To Report My Stipend To The IRS?
If a study participant receives $600 or more in a calendar year, it must be reported to the US IRS (Internal Revenue Service). The study staff will ask you to complete a form W-9, and you will be responsible for reporting this income on your annual IRS return.