For every treatment or drug that’s administered to patients, rigorous experimentation and testing is done before it’s released on the market, to make sure that it’s safe. Clinical trials are a huge part of this testing and are incredibly valuable to the medical community. Individuals who volunteer to participate in clinical trials may also be able to get treatment ahead of the curve — illnesses or diseases that were previously thought incurable might be healed or set back with the drugs and treatments debuting in clinical trials. However, it is important for volunteers to know exactly what is being tested and to receive informed consent. Indeed, informed consent is so important that the American Psychological Association’s Ethical Code’s ninth edition included informed consent in its own section, 8.02. Let’s discuss the steps of a clinical study or what happens during clinical drug development, the benefits, and what you should know when signing up for one.
What are the Phases of Clinical Trials?
There are generally four main phases in a clinical trial that comes out of medical research studies. Phase 1 clinical trials involve a small group of people (between 20-80) who try out an experimental drug or treatment for the first time, to see how safe it is and what side effects crop out. Phase II trials require a larger group of people (between 100-300). The drug or treatment is administered to this larger group to see how effective it is and to continue to monitor its safety. Phase III trials administer the drug or treatment to between 1,000-3,000 people. The purpose of Phase III is to make sure that it’s effective, keep an eye on side effects, compare it with existing treatments that are out there, and get data to make sure that it’s used safely.
After Phase IV, a New Drug Application (NDA) will be submitted by the clinical trial team to be approved by the FDA for release on the market. About 5,000-10,000 drugs enter the research and development phase, but only 250 get to pre-clinical trial testing, five enter the clinical trial testing phase, and just one generally gets to the FDA for approval. It’s comforting to know what rigorous restrictions are put on what can enter our drug/treatment system.
What are the Benefits of Participating in Clinical Trials?
If you’re ill, taking part in a clinical trial can give you access to a drug or treatment that can dramatically improve your health and well-being. Because the drug or treatment is in the testing phase, it’s often usually free or at a much reduced cost, making it affordable for those who might not otherwise be able to afford the treatment once it goes on the market.
By participating in a clinical trial, you’re also helping the medical community and the health of everyone around you, by helping bring new drugs or treatments onto the market. Almost half of people at least somewhat agree that participating in clinical trials is as valuable to the health care system as giving blood is. Furthermore, you’ll have regular and ongoing medical care while you’re participating in the trials, as doctors will want to monitor your health.
What Do I Need to Know or Have Before Signing Up for a Clinical Trial?
Make sure that you have informed consent about all the risks, side effects, and outcomes of the clinical trial you’re participating in, so you can make an informed decision. If you’re participating in a clinical trial for money, know that the later phases do pay less, since they’re being tested on large amounts of people (but also could be safer).
You should clear your participation ahead of time with your doctor and know if there is travel involved, how it could affect your life/routine, and what kind of medical care you can expect to receive over the course of the trial.
Participating in clinical trials can have serious benefits for both sides (the participant and researchers) and help save lives. It’s a good option to consider if you’re looking for extra money or a lifesaving treatment.