Have you ever wondered how treatments and new drugs make it out onto the market? Every new drug or treatment has to undergo rigorous testing and development before the FDA can approve it for use. The clinical drug development process can take years and medical research studies help provide the groundwork for getting new treatments off the ground. Clinical trials along the way are paramount to making sure that the new drugs and treatments are safe for use and for providing those “side effect” warnings you see on the back of all drugs. They can help direct researchers and scientists in more focused ways and work on improving the drug. However, because humans are needed in these clinical trials, anyone who participates in medical research studies or clinical trials needs to be well informed, know their rights, and understand what all possible outcomes might be.

What are Clinical Trials and How Do They Help?
Clinical trials are part of medical research studies, that try and figure out whether or not new treatments, strategies, or devices are safe for use on humans — and whether or not they work. Clinical trials can also target specific illnesses or groups of people and see how a treatment or device works with them. About half of people surveyed mostly agreed that participating in clinical trials is as necessary to improving the health care system as giving blood.

Without clinical trials and a clinical study, researchers would mostly be shooting in the dark — they wouldn’t know how treatments affected us until it was already approved and on the market. This helps keep us safe and largely prevents quack methods from going mainstream.

What are the Different Phases of Clinical Trials?

Clinical trials these days last much longer than in the past. In 2005, the average time of a clinical trial was about 780 days. There are usually four phases of trials.

In a Phase 1 clinical trial, a small test group is used (usually between 20 to 80 people). Researchers administer the experimental treatment or drug for the very first time, to see how safe it is and to figure out side effects.

In Phase 2, a larger group of people receive the drug or treatment (between 100-300) to monitor its effectiveness and to continue to evaluate how safe it is.

During Phase 3, the largest group receives the drug or treatment — between 1,000-3,000 people. In this second to last phase, researchers are confirming how effective it is, what the side effects are, and comparing it to what’s already out there on the market. They’ll also gather the information necessary to ensure that the drug or treatment is used safely.

After this, the researchers send in a New Drug Application to be approved for release on the market. The statistics show it’s a tough process — between 5,000-10,000 drugs are submitted for research and development, but only 250 go into pre-clinical trial testing. Only five of those 250 undergo clinical trials and just one of those usually is approved by the FDA.

What Do I Need to Know If Participating in Medical Research Studies?

If you are participating in medical research studies, you must have informed consent. It’s actually important enough that it has its own section in the ninth revision of the American Psychological Association’s Ethical Code. Know your rights and who to appeal to if there are problems. What is the purpose of the study?

Knowing what’s involved in the trial, what side effects, risks, and benefits might be a result of the trial, how it might affect your daily life, how long the trial will last, and who is in charge of your care are important questions to find out the answers to. Furthermore, know that if someone is under the age of 18, the researchers must legally get consent from their parent or guardian.

Clinical trials have a huge impact on our healthcare system and those who participate in them do a lot to advance research and groundbreaking treatments. However, it’s important to know what to expect going in and how to protect yourself if necessary.