Before becoming a patient I never knew what a clinical trial was, except for maybe seeing how drug trials go horribly horribly wrong in scary movies.
Well they’re not all going to turn us into zombies hungry for brains. Some of these clinical drug trials are saving lives. Maybe I watched too many X-Files and Outerlimits episodes when growing up. Well now my life seems a bit like an Outerlimits episode at times.
I have been on a lot of different drugs for my rheumatoid arthritis, since my diagnosis I know that it takes multiple to find the one that works for you. Each of these drugs had to go through a process to see if it they show an improvement or save someone’s life. I’ve been on about two dozen different medications in the last 5 years, all the information about them had to have been gathered somehow, they had to figure these work for some people and clinical trials is how that happens.
When I found out how new humira or actemra are on the market, drugs that have shown a significant improvement in the lives of people living with different inflammatory arthritis conditions, that really put into perspective for me the importance of advancing medicine. My aunt who’s hands were deformed with the traditional RA deformities and always was in a wheelchair was diagnosed before these options were available. She was diagnosed when they still used gold to treat rheumatoid arthritis. Gold.
I am grateful for the advances in medicine because now they are seeing less deformed hands and less need for wheelchairs.
What Are Clinical Trials?
Clinical research is the study of health and illness in people. Clinical research is how we develop new treatments and gather knowledge for better health and care. Clinical research is also how we build the evidence for potential new approaches to find the ones that are safe and effective.
Before regulatory authorities, responsible for approving medicines for use in each country, can consider an investigational drug, device or procedure for approval, it must be shown to be both safe and work well. Typically, this is accomplished through clinical trials — carefully designed and monitored studies intended to test and evaluate these investigational drugs, devices or procedures.
Every day around the world, researchers and scientists are investigating thousands of potential drugs, devices, and procedures. A very small percentage of those under investigation show enough promise to begin testing in humans. A clinical trial is a research study involving human participants, which tests and evaluates the investigational drug, device, or procedure to find out how safe it is and how well it works. Before any investigational drug, device, or procedure can be approved for use, it must be evaluated in a series of clinical trials. Clinical trials are carefully monitored by various regulatory agencies to ensure the safety of all trial participants who agree to take part. Those regulatory agencies include the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and other Ministries of Health or regulatory authorities in countries around the world. All of them are government agencies that are responsible for issuing rules and regulations in the country of their jurisdiction regarding the conduct of clinical trials.
Why Participate In Clinical Trials
People may be interested in clinical trials for a variety of reasons. Some people participate in clinical trials as a way to contribute to medical science and to help doctors and researchers find other ways to help patients. Others participate in clinical trials to receive investigational drugs because their illness is not responding to standard treatment. Their hope is that the study drug — possibly an investigational drug or an investigational combination of drugs — will work for them. This will not always be the case, because some investigational drug regimens may not work or may have unexpected side effects. For this reason, everyone who participates in a clinical trial is carefully monitored. Frequent study-related medical exams and tests may need to be performed to help monitor the participants’ safety.
How to participate in clinical trials
Please refer to Participate In Research here on my blog for different research opportunities including clinical trials.