Have you heard about clinical trials? These are studies about new drugs or devices in the field of medicine, helpful in the breakthrough of new treatments for various diseases.
Healthy patient clinical trials provide testings like this. These clinical trials are important when learning about innovation in the medical department. They can be very expensive and the stakes are higher for this type of research, but treatment for serious illnesses, like cancer, must undergo clinical trials to get approval from the FDA.
Joining a Clinical Trial
Everyone can join clinical trials but before that, you must follow some steps. Parents or guardians must give permission if they want their child to join clinical trials though older children may be asked themselves. They call the process assent.
When an older child refuses to take part even with the approval of the parents, no clinical trials will push through. Adults can of course answer for themselves. It’s important to note that joining clinical trials means you volunteered for it and nobody forced you to.
The Importance of Clinical Trials
Clinical Trials are the gateways to the success (or not) in the field of medicine. The scientists and doctors doing clinical trials don’t know for sure if it will be successful but that what clinical trials are for. It’s for testing the effectiveness of a medicine or a device.
Doing clinical trials on people will increase the rate of knowing how effective these products are. There are risk much like on anything but these tests will be given to you only after they have already passed other tests. Most tests have passed at least 3 tests before they will administer on you. For example, studies on cancer drugs will take at least 6 years first before it reaches clinical trials.
Who’s Qualified to Join Clinical Trials?
As said above, a drug or a device will undergo many tests before reaching clinical trials. These tests take years before it can reach clinical trials. One of the major factors that scientists and doctors consider is if it’s safe. They also consider if what works well in cell studies and animal studies will apply to the people who volunteered.
What is the Investigational New Drug Application?
Investigational New Drug Application or IND is a request that researches file when studying drugs in humans. Several details need to be in the request to file it. These things are pre-clinical studies wherein all the information from the studies must be included to get approval from the FDA. Another one is the manufacturing information which narrates the makeup of the drugs and explains how stable it is to use in humans.
The last is the clinical protocols and information on the researchers. The study protocols are about the study and how it might put the volunteers at risk. The researchers will be evaluated if they’re fit to do the clinical trials. Lastly, it’s about the ‘informed consent’ from the volunteers that a research sponsor ‘must commit to getting’.
Clinical Trials Are for Not Just for Treatment Studies
Clinical Trials study various fields of medicine. It can be about treatments, drug trials, a study on approved drugs, and devices. They research about detection, diagnosis, prevention and the extent of diseases. Researchers also conduct studies about new procedures like surgery, alternative medicines or therapy techniques. Even approved drugs sill need verification for its effectiveness when combined with other drugs.
What Clinical Trials Can Do For Its Volunteers
Finally, the best part of joining clinical trials would be the fact that if a drug being tested is effective, you get the chance to be treated. You get a sort of firsthand help from the research study. This can be helpful if you’re actively looking for options.