Understanding Clinical Research
What is a Clinical Trial?
Clinical Trials are research studies that test how well a new medical approach or treatment works for humans. The types of treatments tested in a clinical trial can include a new screening tool, a prevention, a diagnosis or a new medical device or treatment. Medications and treatments tested in a clinical trial can include a new vaccine, dietary choices or even testing an already FDA approved medication for a different disease than the one for which it was originally created. Clinical Trials help scientists and doctors understand what works best by studying the data and results from clinical trials. Before a Clinical Trial can be approved by the U.S. Food and Drug Administration, scientists must first test the new treatment in animals in a laboratory to understand the safety and effectiveness the treatment. If a new treatment shows favorable signs of being safe and effective in animal tests, then it is approved for a Clinical Trial in humans. The FDA requires many types of Clinical Trials to be listed on clinicaltrials.gov but there are also other types of health research studies available to both healthy and sick individuals.
Clinical Trial vs. Clinical Study
While Clinical Trials are designed to test new medical approaches and treatments, Clinical Studies (or Observational Studies) are designed to observe the health of different groups of research participants as part of their normal environment or medical care. Research participants in a Clinical or Observation Study may still receive some sort of treatment or use a medical device, however, the use of the treatment or device is part of the participants’ routine medical care and is not assigned by the investigator as it would be in a Clinical Trial.
Why Do We Need Clinical Trials?
Clinical Trials help researchers understand what treatments and devices work best for different types of diseases and for different groups of people. Clinical Trials can be used to test how well a new pacemaker works, or the role of a caregiver whose family member has Alzheimer’s disease. Clinical Trials can also help test if a new medication for cancer treatment has fewer side effects than the current treatment. Medications and treatments that were used 20 years ago have now been replaced with new medications and treatments that are safer for patients and work better because of Clinical Trials. Clinical Trials also help us understand how diseases affect certain groups of people differently. For instance, a treatment may work differently in woman than it does in men or may have different side effects in Hispanic people versus African Americans. Research done in a clinical trial can help us to understand how to tailor treatments to different groups of people instead of a one-size-fits-all approach.
Are Clinical Trials Safe?
Investigators that lead Clinical Trials and Clinical Studies must follow a strict set of rules, known as a research protocol. These investigators are required to have their Clinical Trials proposals go through a rigorous review to ensure good scientific practices and to ensure the safety of participants. A committee called the Internal Review Board is made up of members that are not connected to the Clinical Trial that is being reviewed. This committee of independent reviewers works to ensure that the rights and well-being of human participants are protected. The IRB requires investigators to submit any changes in the research protocol for review and approval before the investigator can implement those changes. Investigators and their teams are required to go through special training to ensure participants rights, data and safety are protected. Many Clinical Trials are also required to have a Data Safety Monitoring Board, an independent committee of scientists and doctors who regularly review the data from the clinical trial to ensure that participants are not being harmed and that the research team is practicing good scientific methods.
Who Can Participate in a Clinical Trial?
We are glad you asked! Anyone can participate in a clinical trial, healthy or sick! In fact, many people believe that they have to be sick already to participate in a Clinical Trial but researchers need healthy volunteers too. Each Clinical Trial has a set of eligibility requirements that have been approved by the Internal Review Board. Even if you do not meet the eligibility requirements for a particular clinical trial, there is a strong chance you will meet the requirements for a different Clinical Trial. The easiest way to get started is to become an ALL IN for Health research volunteer. Simply create an account, answer a few questions about yourself, and you will get matched to clinical trials for which you are eligible to participate. If you are looking for a specific type of clinical trial, you can also search our list of research studies and contact the research team directly.
Research gives me life, and it gives me a chance at having a full life.
“My experience in three clinical trials has been phenomenal. Although not cured, my quality of life for the nearly four years since diagnosis has been excellent. The professionalism and compassion of my [physician], the nurses, and staff have been truly exceptional.”
“Research studies not only offer the potential for improved treatment to the individual clinical trial participant, but very importantly, provide the means for development of improved and safe therapies.”