For those looking to make some quick money, there are always clinical trials or medical research studies who offer a pretty penny for test subjects. Of course, today there are plenty of guidelines and restrictions set for patients who agree to participate in medical research studies, especially if the patient is under 18 years of age. These volunteers, however, are often a huge help with clinical drug development and in providing results for a clinical study. There are usually four phases in a clinical trial and phase III requires the most amount of people to test the drug. Additionally, today, clinical trials go on for significantly longer than they did even twenty years ago, thanks to updated health and safety guidelines. Medical research studies and clinical trials can take place at an individual research center, or even in linked research centers all around the country, depending on the size and scope of the experiment.
What Is a Clinical Trial? What’s Involved?
Clinical trials are a step in clinical research, where experiments or observations are used to gauge the safety and efficiency of the item being tested. Often, these involve new treatments (think, vaccines, dietary supplements, new drugs). Clinical trials can only be done once they’ve gotten approval from the health authority or ethics committee in their country and making sure that those who participate in the trial are safe and/or know the possible risks involved in participating in the trial.
In a phase 1 clinical trial, researchers test the drug or treatment on a small group (usually between 20-80) for the very first time. Phase 1 looks at the safety of the drug or treatment and sees what side effects the drug is responsible for producing. This stage, for example, is where all the side effects warnings come from on your drug bottle or at the end of drug ads.
Phase II trials test the drug or treatment on a somewhat larger group of people (this time between 100-300) to see how effective it is over a large swathe of people and to further get a handle on how safe it is.
Phase III trials have the largest amount of test patients (1,000-3,000) to confirm how effective it is, keep an eye on side effects, run comparisons between standard treatments or other treatments that have similar effects, and gather data that will let the drug or treatment be used safely.
Once Phase IV trials have been completed, the clinical trial team will put together an NDA (New Drug Application) form to be approved. This releases the drug into the market.There are usually about 5,000 to 10,000 drugs that go into research and development during a year, but only about 250 of these ever get to pre-clinical trial testing, five get to clinical trials, and usually just about one will ever make it to FDA approval.
What Safeguards Are In Place for Patients Who Undergo This Testing?
Consent iision of the American Psychological Association’s Ethical Code, informed consent received its own section, 8.02. If researchers in medical research studies plan on having children as part of their test subjects (anyone under the age of 18), they legally must get consent from the parent or guardian of the children.
The Institutional Review Board (IRB) is also in place to help protect patient rights. They provide scientific oversight for the trial and make sure that the trials are ethical and that patient rights are being protected. The IRB is made up of independent members created by whatever entity is sponsoring the trial. Members can include doctors, community members, statisticians, and others.
The IRB will check the protocol of the trials pre-study and also check up on results over the course of the study.
The Office for Human Research Protections also provides a measure of safety, offering guidance and support to the IRB and distributing educational material.
If you’re thinking about participating in a clinical trial or medical research study, do your research too. Know your rights and who you can turn to for help, should you need it. Be sure to read all the fine print and don’t be afraid to ask questions.