In a recent conference held by government officials entitled “A National Call to Action”, clinical research was described as a part of medical and health research intended to produce valuable knowledge for understanding human disease, prevention and treatment of illness and promotion of health. Castlerock Clinical Research was established in 2002 to help patients and physicians respond to this national call.
WHAT IS A CLINICAL RESEARCH STUDY? Clinical research protocols are designed by the pharmaceutical sponsor, approved by the Food and Drug Administration and implemented by research sites that are monitored by Institutional Review Boards. Patient safety and pharmaceutical agent efficacy are the primary goals of clinical research trials. Castlerock Clinical Research is currently involved in clinical trials that enroll adult internal medicine out-patients. Prospective patients are self referred or referred by primary care physicians and enrolled in clinical trials following strict inclusion/exclusion criteria. Adult Internal Medicine research protocols target patients with a wide range of disease processes from the metabolic syndrome, high blood pressure, cholesterol abnormalities, and diabetes to such problems as “heartburn”, irritable bowel syndrome, chronic bronchitis, pneumonia and many other conditions.
Individual research protocols offer patients not only the latest pharmaceutical therapy, but include as well, patient education specific to management of the disease under study. Most clinical trials offer frequent laboratory testing, electrocardiogram, chest x-ray, and physical exams, and many studies offer specialized testing procedures such as echocardiogram, exercise testing, or colonoscopy each according to the disease under study. Often, health monitoring devices such as blood glucose meters and blood pressure monitors are supplied to patients as well. All drugs, testing, and supplies specific to the study protocol are free to the patient.
WHY VOLUNTEER? Subjects taking part in clinical trials can try new treatments that may or may not be better than those that already exist. They can also help others better understand how the treatment works in people of different races and genders.
In the past most drug testing had been done on white men. Data collected from these studies may or may not be accurate for other genders and ethnic groups. The FDA needs data collected from all genders and ethnic groups to ensure that data applies to all who might be exposed to the drug.
WHAT ARE THE RISKS? Some treatments, that are under investigation, have side effects that can be unpleasant, serious or even life-threatening. Side effects are not always known and are part of the reson for studying new therapies. Many side effects are temporary, and others may go away when the therapy is stopped.
The risks depend on the treatment being studied, and all known risks are fully explained, both by study personnel and within the Informed Consent Document.
WHAT IS INFORMED CONSENT? The FDA required that all subjects be given complete information about the study, including:
- The purpose of the study
- How long the study will last What happens at each visit
- Possible risks or discomforts
- Possible benefits
- Other available treatments
- Confidentiality related to research studies
- Treatments available if you are hurt
- The contact person to call if you have questions
- The fact that you can withdraw at any time
Informed Consent must be understood and signed before any study procedures are started. A copy of the signed Consent is given to the subject.
HOW AM I PROTECTED AS A STUDY VOLUNTEER? Institutional Review Boards (IRB) review and monitor the research institution’s medical research. The board monitors data to help make sure that there is the least possible risk to volunteers and that the risks are reasonable.
Data Monitoring Committees (DMC) review information from studies to make sure they are being done in a way that is safest for volunteers. During a study, if the committee finds that the treatment is harmful or of no benefit, the study will be stopped. If it is found that one treatment works better than another, the committee will stop the study and all volunteers are offered the better treatment.
Food and Drug Administration (FDA) inspects records, investigators and research sites to make sure volunteers are being protected and studies are being conducted correctly.
HIPPA (Healthcare Information, Portability and Accountability Act) requires organizations to protect medical information (PHI) of their patients. Castlerock Clinical Research subjects are required to sign HIPPA authorization at their first visit and receive a brochure detailing their rights under this law. Clinical Research subjects agree that they will not request to see or copy their PHI until the study sponsor has completed all work related to the study. In summary Castlerock Clinical Research subjects are informed of the nature of the trial, questions and concerns are answered throughout the trial, and patients are given the tools to continue a healthy lifestyle and maintain a high level of health maintenance, even after completion of a clinical research trial.
For online information regarding participation in clinical research trials, visit CenterWatch.com. Information contained at this web site describes the Clinical Trial process, lists many current research trials, and describes clinical research sites state-by-state.
For more information or for patient or self-referral, call Castlerock Clinical Research at (918) 524-5205.
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© 2013 CASTLEROCK CLINICAL RESEARCH CONSULTANTS