Clinical trials are amazingly important in todays society. As we have grown and evolved as a race, we have started asking ourselves difficult questions regarding the conditions and ailments that effect so many of us on a daily basis. Clinical trials try to answer these questions we have in order to cure them. They try to determine if a new medical treatment or device is safe to be used by humans. They aim to give us the most reliable data to aid health care decision-making.
If you have ever wondered what actually goes on in a clinical trial and how they actually work, then look no further as we explain the ins and outs of clinical trials right now.
Phase one clinical trials have to adhere to a comprehensive plan which is the written description of what the clinical trial will entail and what the study objectives, design and methods are as well as relevant scientific background and statistical information. These can include, but or not limited to: The amount of patients, what patients are eligible to take part, what tests the patients will receive, the type of data that is going to be collected and the length of the study.
The researchers will then take measures to avoid being bias. This includes a number of things like comparison groups, randomization and masking so that they can get as fair a study as possible.
You may wonder as well whether clinical trials are safe. Of course, you are likely to trust people in white coats, even if you do not understand everything they are saying. But it is useful to know that the FDA works to ensure that everyone wishing to take part in a clinical trial is given as much reliable information as possible to be able to make an informed decision whether or not they wish to join a clinical trial. The participants safety is always highly prioritised and every trial has a scientific oversight and patient right to assist in their protection.
During the trial, all of the information collected about the participants will be kept confidential, as with any other medical records. When investigators publish the results of a trial, they are not allowed to include any information that would identify people a patients name will not be used in any reports or publications.
So there it is, everything you need to know about clinical trials. Hopefully this will be enough information to let you know whether you will be a willing participant in one (depending on the trial itself).