Before new drugs and treatments become available on drugstore shelves, the medications need to go through numerous tests and follow protocol before they can be approved by the FDA. The FDA is the agency responsible for the regulation and promotion of over the counter drugs and prescription medications. The information that is sent off to the FDA during a request for approval is compiled from studies known as clinical trials.
A clinical trial is a study that aims to gather information on both the efficacy and safety of certain medications. There are a host of guidelines and specific protocols that need to be followed during a clinical trial, making it quite time consuming and expensive to operate.
There are five phases in a clinical trial, each of which serves a specific purpose. Clinical trials are used mainly for testing the drug on successfully larger groups of people. First, a therapeutic dose is used on a group with a few dozen participants. Depending on the findings in this phase, the clinical trial would then move onto the next phase, where a larger group of participants are used, ranging in the thousands.
All clinical trials are conducted by a team of doctors, nurses and social workers. The doctors are responsible for the medical care, ensuring every patient’s well-being throughout the study. Most trials require individuals of different medical backgrounds, ethnicities, age and gender. Due to these restrictions, you may have to complete an eligibility survey to ensure that you are an ideal candidate for the trial.
There are a number of benefits of a clinical trial, as it promotes new treatment methodologies, allows for innovative preventative care and improves quality of health care. Throughout a clinical trial, every participant is analyzed, depending on the type of clinical trial being researched.
Observational clinical research mainly looks at the change in an individual without administering any medication or drug. Interventional clinical trials are when a drug is administered to the participant and its effects are studied. In both cases, a medical professional will be available during the clinical trial.
Since clinical trials are used to study the effects of one specific drug or condition, it is important that you only participate in one trial at one time, so as to not bias the results of the study. Depending on the phase you’re participating in, a trial could last from a few weeks to a few years at most.
Before a participant is included in a clinical trial, the doctor would go through the benefits, risks, purpose of the study and potential side effects with the participant. Only once the participant has signed an Informed Consent document will they be included in the clinical research. As it isn’t a legally binding contract, you are free to withdraw from a clinical trial at any phase of the research.
However, keep in mind that you will have access to the utmost medical care throughout the entire clinical trial. The safety of all participants is extremely important during clinical research and qualified investigators are available at all times. Interested participants should also speak to their primary health care physician about their long-term care.
For more information on clinical trials, visit discoverclinicaltrials.com to search every clinical trial happening around the world. Discover Clinical Trials only takes on phase 3 clinical trials or phase 4.