A clinical trial can be an intimidating concept to anyone who doesn’t understand what they are or what they intend to accomplish. In fact, they’re quite important, and so are trial volunteers!
Medical institutions and the pharmaceutical industry use clinical trials to conduct research on various drugs and procedures in development. Through trials, researchers test the benefits and risks of new options for patient care, evaluating symptoms, side effects, patient behavior and more to understand how medical research should proceed, and whether or not a medication or process should be pursued and made available to the public. All collected data is geared towards development of new and better methods of patient care.
These trials have enormous benefits. Not only do they create effective and safe medical treatments & processes, they provide thousands of people opportunities to contribute to the healthcare industry and the wellness of people worldwide.
More than 6,200 clinical trials have taken place, and more are starting every year. To learn about these trials, keep reading below.
Medical research is taken very seriously. Researchers are required to complete a meticulous screening and preclinical testing process of medications before the trial can begin.
Once a treatment is ready to be used in a trial, the pharmaceutical company files an Investigational New Drug (IND) application with the Food and Drug Administration (FDA), which permits them to test the treatment on willing participants in clinical trials.
A clinical trial is led by a principal investigator, such as a medical physician, and his or her research team. It is subject to a number of reviews and approvals by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, local community advocates, and other industry professionals. This ensures patient rights are protected and ethical conduct is assured in every trial.
Clinical trials are split into three phases:
If the medication is deemed safe and effective after all three phases, a request to the FDA is sent for approval to market it to the general public.
The FDA requires that a multi-phase clinical trial process take place before declaring a drug or treatment safe and effective. This is why volunteers are essential to the process.
Volunteers can be assured that medications moving to clinical trial have already been extensively tested and researched for many years, and strict guidelines monitor how testing is performed when volunteer patients are involved. Medications are only given to humans if testing has indicated that they are extremely likely to have no harmful impact.
Volunteers can expect to be thoroughly educated prior to and during the trial about what to expect, their rights, and their ability to leave the trial at any time. Volunteers will have access to medical professionals to ask any questions and share their experiences.
There are a number of myths about participating in clinical trials, and you can learn more facts about participating in trials through PhRMA.
Clinical trials concerning asthma, cancer, diabetes, heart disease, stroke, and mental illness are among the most prevalent in New York state.
Some of the top clinical trial research centers, university medical schools, and comprehensive cancer centers are in the Empire State. Columbia University, Cornell University’s Weill Medical College, Mount Sinai School of Medicine, New York University, the University of Rochester, Albert Einstein College of Medicine at Yeshiva University, SUNY University at Buffalo, SUNY Stony Brook University and SUNY Upstate Medical University at Syracuse are among some of the more renowned and respected research-oriented medical schools available in New York.
Currently, over 700 tests for new medications and treatments are underway in New York alone, and all are actively seeking volunteers. New and innovative medicines are waiting on the right resources to help them move into review, and amazing breakthroughs are being made every day through this research.
In many cases, clinical trial participants are paid, but requirements for participation are rigorous. To learn more about clinical trials, find one for you, and apply to become a clinical trial volunteer, visit the National Institutes of Health Clinical Center database.