How Do Clinical Trials Work?

How Do Clinical Trials Work?

March 16, 2016

Every day, thousands of volunteers participate in clinical trials across the country. In 2016 alone, 210,314 clinical studies are currently in progress, across all 50 states and in 192 countries. The data obtained in these research studies will help shape future treatments available to the American public.

Clinical trials are scientific studies that determine whether or not a medication or medical device is safe for human usage. All volunteers should understand the basics of clinical studies before signing up; this article will give you an overview of what you can expect, should you choose to participate.

Establishment Of Study Eligibility

Every clinical study has an established set of eligibility rules, which help pharmaceutical companies ensure thorough testing on diverse groups of people, as well as establish medication safety and/or efficacy. The average clinical study criterion may involve age, race, gender, medical conditions and previous health history. Clinical trials may also have exclusionary criteria to ensure scientifically valid results.

Understand The Volunteer Experience

Participants will always be informed of the study length prior to enrollment, but the overall duration does vary. As a general rule of thumb:

  • Phase one studies typically lasts a few weeks to several months
  • Next, phase two studies span several months to approximately two years
  • Phase three studies may take anywhere from one to four years
  • Lastly, phase four trials occur after the drug has been marketed, to determine its effect on various populations and any known side effects. Clinical studies at OCRC range from just a few days to 6-7 months.

Understand Clinical Trial Protocol

All clinical trials adhere to a master plan, otherwise known as study protocol, which outlines patient eligibility info, data parameters and treatment plan information. Researchers strictly follow these guidelines in order to avoid human bias.

Some additional steps taken to eliminate human bias include:

  • Random patient assignment to one or more groups
  • Participants not receiving the new medication, or receiving a placebo
  • Researchers refraining from discussing which group receives the new medication, which further helps isolate the side effects of a medication. Note: All clinics will inform patients if safety concerns arise.

Learn More About Clinical Trials, the FDA website and our blog catalog are all great sources for information about clinical studies. Our staff at OCRC is also happy to offer tours at our state-of-the-art clinic to volunteers who meet study criteria.

At OCRC, We explain our methodology to every participant and we pride ourselves on the policies we put into place to keep everyone safe — both our staff, and study volunteers. The Phase I-IV clinical trials that we specialize in test investigational medications being developed by pharmaceutical and biotech companies. All participants also receive free treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

If you are interested in volunteering, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.