What Should I Expect When Signing Up For A Clinical Study?

 

Clinical drug development is one of the hallmarks of a modern society. Much of what we enjoy in the day-to-day, or need to survive, is thanks to the ongoing efforts of medical research facilities and the volunteers that support them. From more common painkillers to life-saving antibiotics, the majority of what we see on store shelves would not be possible without clinical trials. It’s important to be aware of how clinical trials work and what you should expect should you decide to sign up. Like becoming a blood donor or donating plasma, your decision will have a positive, long-term impact down the road.

Clinical trials today are much different than they were a few decades ago. The very first clinical trial was completed back in the late 1700’s in an attempt to treat scurvy, a condition now known to be caused by a severe lack of vitamin C. Back in 1999 a clinical trial would last an average of 460 days. Compare this to 2005, where clinical trials would last an estimated 780 days before reaching a conclusion. This is due to increasing standards and changing perspectives on what constitutes a more complete, successful and safe trial.

Consent is paramount to safe working conditions and no clinical study, big or small, can be completed without it. Informed consent is so important that the American Psychological Association’s Ethical Code created an entire section dedicated to it in the 9th revision. Researchers that plan on using children (anyone defined as younger than 18) are required to legally obtain consent from the parents or a legal guardian. Failure to meet these parameters will ensure the trial does not continue.

Each trial will go through a phase, with each phase gradually growing larger as progress is made. Phase 1 clinical trials will have researches testing either an experimental drug or treatment in a small group of people — as small as 20 to 80 — for an extended period of time. The function is to determine the relative safety of the product as well as identify side-effects as soon as possible. Once this state is completed the second phase will be done in a similar manner, this time using a larger group of people. This can range from 100 to 300, depending.

Once the first two phases are done the third phase will be administered to the largest group possible — from 1,000 to 3,000 — to get a complete overview of the information needed to potentially put a new product out on the market. The fourth phase involves the medical research team sending an NDA (or new drug application) for approval by the FDA. Out of the thousands of prospective drugs that regularly enter the testing phase, only 250 will make it to the pre-clinical trial testing stage and just five to the clinical trial testing phase. Just one will make it through the FDA’s approval system per year.

Medical research studies are a necessary and irreplaceable part of the medical field. A recent survey saw 46% of respondents agreeing that taking part in clinical trials is just as valuable to the healthcare system as donating blood. Another survey, however, saw over 90% of respondents saying they have never participated in clinical trials. From the first phase to the potential final approval by the FDA, medical trials are a safe method of obtaining necessary medication from beginning to end. With the efforts of volunteers and experienced medical staff, breakthroughs are always around the corner.