Red Hot Mamas In Charge of Change.
By: Red Hot Mamas
Published: June 30, 2010
Written by Karen Giblin
This month I had the privilege of attending the 43rd Annual Meeting of the Drug Information Association (DIA) in Atlanta, GA. Many of you are wondering, what is the DIA? It is a worldwide organization whose members (more than18,000) are actively involved in the discovery, development, regulation, surveillance, and marketing of pharmaceuticals, biologicals or medical devices. DIA provides continuous education through training sessions and conferences. The DIA headquarters are near Philadelphia and they have other offices in Switzerland and Japan.
Their 43rd annual meeting provided a forum to more than 8,000 attendees to learn and discuss the current issues in drug and devices development. There were 1,000 speakers and 400 educational sessions to choose from and over 500 exhibitors. If you want to learn more about DIA’s activities visit their website www.diahome.org. The topics ranged from drug safety and clinical trial recruitment to natural health products and advertisement to the consumer .
Red Hot Mamas® members are often curious about clinical trials. Many women may ask: what is a clinical trial? It is a carefully designed study that involves people who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Physicians (called investigators) are selected by pharmaceutical or biotechnology companies to conduct clinical trials. Institutional Review Boards (IRBs) review all clinical trials. IRBs are committees set up by hospitals, academic centers or communities to ensure that each clinical trial has adequate medical supervision, provides each patient enrolling in the trial with sufficient information, and receives the investigators regular updates on the trial’s progress.
Clinical trials are conducted in phases (I, II, III, IV). Most trials compare a new treatment to an existing one or to placebo. When you enroll in a clinical trial you are assigned to a specific study group. One study group will receive an investigational study drug; medical device; or medical intervention; some will receive a placebo or a treatment that is already available. You, your physician, and the research staff will not know which treatment you are receiving.
If you decide to enroll in a clinical trial study, you can expect the physician to review your medical history and you will receive a physical examination. You will have to sign a consent form (which was reviewed in detail by the IRB). You will receive quality care and medical attention throughout the study. The investigator will keep track of any symptoms you have and record them. You will be asked many questions as your input is important. All the information collected from you will be given, anonymously to the Food and Drug Administration (FDA) and to over government agencies wherever this drug is being considered for approval, even outside of the USA. The results of the clinical trial research study may be presented in publications or at medical meetings. If you participate in a clinical trial, you have the right to leave the study at any time or for any reason.
After a clinical trial has ended, the information that is collected will be the determining factor as to whether the drug is safe and effective. A review of this data is closely looked at before a drug is approved. Currently, the major problem in developing new treatments is to find the patients volunteering to the trials. I encourage you to learn more about the various aspects of the clinical trial process and volunteer. It is through this measure that new drugs and medical treatments are made available that will impact our lives to prevent or treat diseases. A website set up the NIH (www.clinicaltrials.gov) lists most of the trials ongoing worldwide. I encourage you to consult regularly this database to find a trial that may help you or your family.
