What Are Adverse Events?

Have you ever watched a TV commercial about a new drug, or unfolded that tiny piece of paper inside your medicine box and wondered where the long list of potential side effects comes from? That list of side effects is collected beginning the moment a new drug is given to people. Tracking adverse events is part of the clinical research process.

Clinical research is a detailed, well-documented process. Part of the documentation involves keeping track of every little thing that happens to the volunteer research patients, no matter how small or unrelated it may seem. In clinical research studies, these are called adverse events, however, once the drug is approved and on the market, these type of events are referred to as side effects.

An adverse event is simply another name for a medical symptom or occurrence that happens during the clinical trial. The main goal of clinical research is to develop safe and effective therapies, which require tracking all symptoms and medical developments during the trial no matter how insignificant they may seem.

By keeping a detailed log of these events, researchers can determine what side effects the drug may be linked to and what may be unrelated. For example, if you fall and break your ankle during the trial, that is considered an adverse event, even if it seems unrelated to you. By combining data from all patients in the trial, it could be discovered later the drug causes clumsiness and motor impairment in certain people, which then could be considered a potential side or risk should the drug be approved.

Adverse events can range from a stuffy nose to more serious medical episodes, although the more serious events are usually discovered before the drug enters human testing. Clinvest Research believes in keeping its patients as safe and as risk-free as possible. That’s why at the beginning of every study we sit down with every participant and talk through any of the known potential risks. We also explain the importance of keeping us informed on any small or large changes in your health during the study.

It is important to remember that not everyone will experience adverse events during a trial. By collecting these events during a trial the pharmaceutical companies are able to provide you and your doctor information regarding the potential risks involved with a medication or device. Ultimately, the end goal of our adverse event collection during the trial allows you to make an informed decision about your health when deciding to take a new drug.

 

When you participate in a Clinvest study, your health and well-being are our top priority. View migraine, diabetes, or arthritis trials or call (417) 883-7889 for more information.