Frequently Asked Questions
Q. What is a clinical program?
Clinical research programs are funded by pharmaceutical companies specifically for evaluating the effectiveness and safety of medication on patients.
Clinical trials are experiments that use human subjects to see whether a drug is effective, and what side effects it may cause.
Q. Is clinical research safe?
Before the start of a clinical study strict protocols and procedures are developed. These guidelines are reviewed by an Institutional Review Board to ensure compliance with Federal regulations. This review process ensures that patients are protected and that the program does not present undue or unnecessary risks.
Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. After a sponsor submits an Investigational New Drug application, it must wait 30 days before starting a clinical trial to allow FDA time to review the prospective study. If FDA finds a problem, it can order a "clinical hold" to delay an investigation, or interrupt a clinical trial if problems occur during the study.
During your participation in a study, you will be constantly monitored by our physicians on site and asked about any possible side effects noticed while taking the study medication. Participation is voluntary and may be stopped at any time if you do not like how you are feeling on the study medication.
Primary investigator and the designated sub-investigators shall conduct the study in accordance with all applicable federal, state, and local laws, regulations and guidelines, including but not limited to the Federal Food, Drug, and Cosmetic Act as amended, and regulations promulgated thereunder (the "Act") and the U. S. Food and Drug administration ("FDA") regulations governing the protection of human subjects.
Q. Is the program monitored?
Yes. All patients are monitored throughout the program by experienced and skilled research coordinators and physicians. This monitoring process ensures that program procedures are followed for maximum patient safety.
Studies are also monitored by the drug companies that are sponsoring the protocol. This is usually done on a usual basis and if there are any problems with the study medication or design of the study, it will be directly handled by the pharmaceutical company or designees.
FDA requires an IRB to review all the research documents (e.g., the protocol, the consent form, and the investigators brochure.), and activities that bear directly on the rights and welfare of the subjects of proposed research. Sponsor personnel visit the investigative site regularly to ensure that the investigative staff are in compliance with regulatory requirements and company policies. They also monitor data collection and ensure accurate documentation.
Q. What are the benefits?
Patients enrolled in a clinical research program gain access to research medications. You may have many different medical examinations including blood work, electrocardiograms, etc. perfomed during your participation that you can have copies of at any time. Depending on what study you qualify for, you may be compensated for your time and travel as well.
Tomorrow's Treatment Today. Volunteer patients are always needed to enhance the quality of life for all people suffering from many different psychiatric and medical disorders.
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