Understanding Clinical Trials
You donate to your favorite charity in hopes that they will one day find a cure for that chronic disease which has plagued your family, or maybe even you, for years. You read about research teams hard at work discovering new ideas, developing promising drugs, and creating hope. On the way to finding a cure, medications are developed to minimize symptoms and improve quality of life for those affected. Significant time and money are invested before a drug is deemed beneficial and safe to bring to market.
This process includes clinical trials and to better understand how they work, I sat down with Don Anderson, MD, principal investigator at Desert Valley Research in Rancho Mirage. Dr. Anderson is board-certified in psychiatry and neurology and was Chairman of Psychiatry at Loma Linda University for 16 years.
“Clinical trials play a very important role, and we are all in this together,” says Anderson. “When you pick up your prescription at the store, that drug has gone through extensive clinical trials. It is the only way that new drugs are able to come to market.”
Dr. Anderson notes that there are 4 phases of clinical trials that follow preclinical research; all are defined and monitored by the Food and Drug Administration (FDA):
Phase 1: Studies usually conducted with healthy volunteers that emphasize safety. The goal is to determine the most frequent and serious side effects and the tolerability of different doses.
Phase 2: Studies focus on a population of people who actually have the disease the medication is intended to treat. Emphasis is again on safety in case this population has side-effects not seen with the Phase I healthy volunteers.
Phase 3: Studies focus on a significantly larger population with the targeted condition, and the primary focus is on how well the drug works for its intended purpose.
Phase 4: Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug’s safety, efficacy, or optimal use.
Are clinical trials safe? “A lot of drugs in clinical trials are as safe as, or even safer, than many on the market as companies are trying to come up with medications that work better, have less side effects, and are better tolerated,” says Anderson. The FDA has strict guidelines to safeguard participants, although no clinical trial is free of risk. Requirements, risks and benefits are reviewed in detail so individuals can make informed decisions. In addition, volunteers can withdraw at any time, or the medical director can make decisions based on a participant’s progress. “If we are doing a study on depression and I see a patient getting worse, I will pull them out of the study and work with their primary care physician – or continue with their care at no cost – to do what is in the patient’s best interest.”
Why participate in a clinical trial? There is no cost to participate and volunteers are standardly compensated for their time. “Often patients don’t have specialized care for their condition, or there is nothing on the market for them currently and they want to contribute to finding a solution,” says Anderson.
It is important to fully understand the benefits, risks and potential outcomes of clinical trials prior to volunteering.
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