Patients
Introduction to Clinical Trials
A clinical 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 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 Medical Research South, where the remaining investigations are conducted. At Medical Research South we participate in phase II-IV clinical trials.
We understand that your decision to participate in a clinical trial is very important and very personal. If you meet the eligibility criteria of a clinical 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 trial think about:
Benefits of Participation:
- Education: get an increased awareness of your medical condition.
- Receive at no cost for the duration of the trial, (per clinical 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 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 trial to the Investigator, Institutional Review Board and the FDA.
- Patient volunteers sign the Informed Consent, which details the trial and all potential benefits and risks associated with participation.
We hope that our brief description of clinical trials made the process more clear. If you should have questions, concerns, or you are interested in learning more about trials enrolling in Charleston, please feel free to contact our office at 843-766-5045 or Enroll in a Trial Online.
We look forward to hearing from you.
