What is a Research Trial and Should I Participate?
You probably have questions regarding clinical research and we invite you to read on so that all of your questions can be answered.
WHAT IS A CLINICAL RESEARCH TRIAL?
Every drug, whether a prescription from your doctor or sold over the counter (OTC), must be approved by the Food and Drug Administration (FDA). Think about the fact that every prescription or OTC drug you have ever taken started out as an idea at a pharmaceutical company to help with a certain disease or treatment. Before the FDA will approve any medication, they mandate that a pharmaceutical company go through a process called clinical research trials to prove that it is both safe and effective for whatever treatment it will be used for. Upstate Clinical Research is part of this process. This takes many years to complete and is done in many phases of research trials, which will be detailed for you under Clinical Trial Phases.
SHOULD YOU CONSIDER PARTICIPATING IN A CLINICAL RESEARCH TRAIL?
There are many reasons and benefits as to why a person is interested in clinical research participation. Did you know that all drugs you may take by prescription or over the counter had to go through the research process? You can benefit by participating in several ways. Participation could give you the ability to take a medication that is not yet available to the public for a condition you may have. You also benefit by having an active role in your own health care and decisions. During your participation, you will have expert medical care at our facility and you may help yourself and others through participation. If you do volunteer and qualify, you will receive compensation for your time and travel along with free testing and medication.
WHAT HAPPENS DURING A CLINICAL RESEARCH TRAIL?
The clinical research trial depends on what type trial is being conducted. For more detailed information, go to the section Clinical Trial Phases. During visits, you will see members of our team which include our doctors, nurse practitioners and nurses as well our assistants and administrative staff. You will have scheduled visits where, at a minimum, your vital signs will be checked and new medication dispensed. Other visits may require blood work and an occasional ECG. You will receive education regarding the trial, dosing and we will monitor your health vigilantly during the trial, and stay in touch with you after the trial is completed.
WHAT ARE THE RISKS OF PARTICIPATING IN A RESEARCH TRAIL?
As with all medications, even those already approved, there are side effects. Each potential risk is identified in the Informed Consent which every participant must sign prior to study entry. This is completed at your first visit where you will also be able to ask any question you may have.
WHAT IS AN INFORMED CONSENT?
The Informed Consent is a written form that lists key facts about the study for which you volunteer. It helps you to decide if you want to sign consent and begin study participation. The main topics it covers are: Why the study is being done, what will take place at each visit, how long the study is, information about the actual study medication, its side effects and benefits. It will also inform you of the right you have to withdraw your consent and stop your participation at any time during the study.
HOW AM I PROTECTED WHEN PARTICIPATING IN A RESEARCH TRAIL?
Our government, through different agencies, has very stringent guidelines for the conduct of research trials to protect volunteers. All trials conducted at Upstate Clinical Research are regulated by the FDA.
DO I STILL SEE MY PRIMARY CARE PHYSICIAN WHILE I AM IN A TRIAL?
Always! Your primary care physician is your immediate care giver. Although you will see physicians at our office, you still need to maintain your regular visits with your primary care physician. In addition, any blood work or ECG’s done through the study at no cost to you or your insurance company may be given to your primary care physician so he has the most recent of these tests.
WHAT IS THE STUDY PROTOCOL?
The protocol is the carefully designed plan that the pharmaceutical company submits to the FDA to get approval to conduct a research trial. It is designed to answer specific question about the study drug but to also protect the safety of the study volunteers.
WHAT ARE THE DIFFERENT PHASES OF RESEARCH TRAILS?
There are four different phases of clinical research trials. Upstate Clinical Research conducts Phase II, III and IV.
- Phase I trials: When only a small group of participants (10-80), usually healthy adults, are given the drug initially so that’s its safety, a safe dose and any side effects can be determined.
- Phase II trials: This is a study for a larger number of participants (100-300) to find out if the drug is effective and safe.
- Phase III trials: This phase involves a much higher number of participants (1,000-4,000) so that the pharmaceutical company can confirm that its drug is safe and effective for the medical indication they have been studying it for.
- Phase IV trials: This is a post marketing study and this phase never has a placebo arm
WHAT IS A PLACEBO?
In research trials a placebo (an inactive substance) that contains none of the study medication but will look just like it. Research often has a placebo to help determine the study drugs effectiveness.