Clinical Research in Charleston, SC
Introduction to Clinical Research Trials
A clinical research trial is a well-controlled scientific study that investigates the safety and effectiveness of new and existing medications. In conjunction with local physicians and pharmaceutical companies, a clinical research trial collects the information necessary for a medication's approval by the Food and Drug Administration (FDA), a process that includes years of research and development.
The participation of patient volunteers is vital to the investigation of new and existing drugs. Clinical reseach begins in the lab, it proceeds to animal testing, and after a new drug shows promise, the study continues in research clinics such as Clinical Research South, where the remaining investigations are conducted. At Clinical Research South we participate in phase II-IV clinical research trials.
We understand that your decision to participate in a clinical research trial is very important and very personal. If you meet the eligibility criteria of a clinical research trial, you will then need to consider the possible benefits and risks associated with the study. You can then decide if participating is the right choice for you. Remember, you're a volunteer; your decision to participate is yours and yours alone.
If your considering participation in a clinical research trial think about:
Benefits of Participation:
- Education: get an increased awareness of your medical condition.
- Receive at no cost for the duration of the research trial, (per clinical research trial): physical exams, laboratory tests, diagnostic procedures.
- Access to care that you might not otherwise have, no insurance required
- Compensation for time and travel
- A sense of good will, participation in a project that may benefit your own health as well as that of your fellow man.
How are patient volunteers protected from undue risk?
- Physician Investigators are provided a copy of the Protocol, a detailed report of the research trial, and the Investigator's Drug Brochure, which describes the efficacy and safety findings to date of the medication being investigated.
- Protocols include safety parameters such as Inclusion/Exclusion criteria to identify the right patient for the right study.
- Serious Adverse Events are reported throughout the research trial to the Investigator, Institutional Review Board and the FDA.
- Patient volunteers sign the Informed Consent, which details the research trial and all potential benefits and risks associated with participation.
Phases of Clinical Research Trials
Clinical Research South participates in phase II to IV clinical research trials. Below is a basic overview of each phase:
Phase I Clinical Trials:
Phase I marks the beginning of clinical research trials in human volunteers. A small group of people, usually between 20 and 100 subjects, are treated with the new medication or treatment. The purpose of this phase is to determine how a particular medication or treatment works with the body. It is at this point that the safety of the medication or treatment is determined, dosage levels are established, and side effects are identified.
Phase II Clinical Trials:
Phase II research trials go a bit further. These research trials generally enroll between 100 and 300 patient volunteers. The goal of this phase is to determine the effectiveness of the medication or treatment being investigated. Clinical research trials for medications and treatments in this phase can last several months to several years. These research trials are often randomized research trials, which means patients are randomly placed in groups that receive different medicines and/or treatments. For example, one group receives the experimental drug and the other group serves as the "control" group and receives a placebo, or a pill that contains no active medication. These research trials are often double blinded, which means neither the patient nor the clinical study team (physician and clinical research coordinator) know which group the patient is participating in.
Phase III Clinical Trials:
Phase III research trials generally involve several hundred to several thousand patients. During this phase large scale testing is performed and the research trials may last several years. With more participants, the pharmaceutical companies have a better grasp on the effectiveness of the medication, the benefits, and the possible risks associated with the medication being investigated. At this point, pharmaceutical companies are also comparing their medication to others that are already on the market. Most of the research trials performed are randomized and blinded research trials. At the completion of a phase III research trial a pharmaceutical company is able to request FDA approval so that they can market the medication or device to the general population.
Phase IV Clinical Trials:
Phase IV research trials are usually post-approval clinical research trials (medications already approved by the FDA). Pharmaceutical companies compare their medication (already approved by the FDA) to other medications already on the market. Phase IV research trials determine which products work better for the patient, as well as, the product's cost effectiveness. In addition, pharmaceutical companies conduct Phase IV research trials to determine a medication's long term effectiveness and how the medication affects a patients day-to-day activities and quality of life.
Where can I get more information on Clinical Research Trials?:
- Clinical Research South is currently enrolling patient volunteers for the following medical conditions.
We hope that our brief description of clinical research trials made the process more clear. If you should have questions, concerns, or you are interested in learning more about research trials enrolling in Charleston, please feel free to contact our office at 843-766-5045 or Enroll in a Research Trial Online.
We look forward to hearing from you.
