About Clinical Research
Have you ever wondered how new medications are developed or how a doctor knows which medication and dosage works best? Before a new medication is approved, it must undergo a series of lengthy and rigorous tests, first in the laboratory, then with animals, and ultimately in those with the disease the medication is used to treat. Each year, billions of dollars and millions of man hours are spent researching new methods for the diagnosis and treatment of illnesses and diseases.
A new medication must not only be shown to be safe and effective, but in many cases it must also demonstrate a superior benefit when compared to similarly approved drugs. Nine out of ten new drugs fail to make it through the many phases of research and development. For those that are successful in trials, five or more years may elapse from the time the clinical research process begins to the time the Food and Drug Administration (FDA) approves the drug for use by the general public.
Is It Safe?
Clinical research studies are conducted in strict accordance with research plans (protocols) that have been developed by pharmaceutical companies and reviewed by the FDA along with an Institutional Review Board (IRB) representing the public interest. Once a study has begun, its progress is closely monitored by each of these agencies.
Participants are evaluated frequently throughout the course of the study to monitor effectiveness and safety of the medication. Participants may withdraw from the study at any time, or they may be withdrawn if the investigator feels that it is in their best interest to do so. Upon completion of the study, patients are usually given options for alternative treatments as the medication under the study will often not be available for another year or two.
Questions about safety should be directed to Sterling Institutional Review Board (SIRB) or Biomedical Institutional Review Board (BIOMED), independent review boards that provide protection for human subjects through the initial and ongoing review of research studies and the investigations and facilities that conduct them. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to take note of any possible risks to study participants versus any potential benefits. An IRB by definition is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. The SIRB and BIOMED operate in compliance with the U.S. code of federal regulations, FDA regulations on human subjects research , and the International Conference on Harmonisation (ICH) guidelines.
For additional information regarding clinical research oversight, please contact
Sterling Institutional Review Board
6300 Powers Ferry Rd., STE. 600-351
Atlanta, GA 30339
TOLL FREE: (888)636-1062
Biomedical Research Institute of America
2525 Camino del Rio South, Suite 300
San Diego, CA 92108
or visit the office for Human Research Protections Website at OHRP.