Most people have heard of clinical trials but only understand how they work in vague terms and often associate them with negative stereotypes. There is a long and dark history surrounding clinical trials, but recent efforts and regulations have made participating in clinical trials safe while giving patients the opportunity to try cutting-edge treatments. At Quest, the Specialty Clinical Trials BioPharma team supports testing for phase I-III clinical trials every day.
A novel drug can take up to 20 years and a billion dollars to get approved by the FDA. The process starts with preclinical studies where a novel drug is tested on animals to see if the researchers’ theory works in a living being. If it works as expected, testing of the drug moves into phase I studies which are generally very small groups of healthy volunteers or, in cases where the drug is already known to be safe in people, patients with a different disease who have not responded to other therapies. These are called safety trials and the goal is to find the optimal dose for the new drug with the fewest side effects. Phase II studies are done on slightly larger groups, and the goal is to determine if the drug actually works for the disease, while continuing to understand its safety implications. If the drug passes this stage then phase III studies are started. These are generally large studies that span several years and look to determine if the new drug works better than the existing standard of care treatments. If a drug passes this phase, it has beaten the odds and is the 1 in 5,000 to actually make it through this process and onto the market.
The goal of all of these trials is to progress research and knowledge, while offering new and effective treatment options to patients coping with a devastating diagnosis. The Sponsors of these trials also often help pay for medical and travel costs for patients enrolled in their trial, and offer them the opportunity to use their burden as a way to help other people in the future.
Quest offers the expertise and specialized testing that is required to identify and enroll subjects into these clinical trials, monitor a subject’s disease and overall health while they are on trial, and perform exploratory testing to support future research. Quest also provides phlebotomy services at our Patient Service Centers and at patients’ homes to make participating in these trials easier. Quest supports so much important work, and part of this includes giving patients hope for a little more time, the opportunity to advance research, and to simply have a better quality of life over their last days.