Who conducts clinical research trials?
Pharmaceutical companies, research institutions, or other health organizations may be the sponsor of a clinical research trial. Sponsors are responsible for funding and designing the protocol. A protocol is a set of approved guidelines that clinical investigators, like LSR, follow to conduct the trial. Although pharmaceutical and biotechnology companies sponsor a clinical research trial, only trained doctors, nurses and medical researchers actually conduct the trial.
What are the benefits of participating in a trial?
The two primary reasons to participate in a clinical trial are to potentially help yourself and to help others. It is possible the investigational treatment being tested will improve your health or an illness-related problem. Participants in clinical research trials receive close medical attention throughout the trial, increasing their understanding and management of their disease.
You may also decide to participate in a clinical trial for the satisfaction that comes from being a part of scientific research. Every day there are people hoping for a breakthrough treatment that will make coping with an illness easier or eliminate it altogether. Clinical research participants may help make those discoveries available to people all across the country and around the world. Remember, deciding whether or not to participate, or continue to participate in a trial is entirely up to you.
What are the risks?
Risks vary from trial to trial. Unfortunately, no one can say with certainty what the risks of a particular trial might be. Although researchers expect certain results from each trial, the fact that a treatment is still being studied makes it impossible to guarantee that side effects or adverse reactions will not occur. While it is possible that some side effects could be permanent or even life threatening, most are temporary and go away as soon as the treatment is stopped.
Who is eligible to be in a clinical research trial?
Every clinical research trial attempts to answer very specific research questions. To do this, each trial has certain requirements about your health, medications, age, symptoms, and more. You must meet the requirements of a particular trial to be eligible to volunteer. However, if your health history does not fit one protocol, you may be eligible for a trial with a different protocol.
What happens at a clinical trial?
Participating in a clinical trial is much like a regular visit to a hospital, medical clinic, or doctor’s office, but with greater personal attention. During study visits, information is collected from participants, investigational drugs are dispensed and accounted for, and specific testing of blood, heart or lung function may occur. At all times participants are treated professionally and with care.
What is needed of me?
Your first responsibility is to fully understand your commitment to the trial. The research team needs you to come to appointments on time, follow instructions carefully, and especially take any medication exactly as instructed. Your full cooperation and participation is needed if the investigators are to collect the information required for a successful study.
What can I expect from the clinical research trial team?
More than anything else, you have the right to expect complete information about the trial. Do not participate in any clinical research unless your questions have been reasonably answered. You will be given an informed consent form to read and sign. This is required by law to make sure you understand what is involved in a trial. It should include an honest discussion of potential risks and benefits. You should also expect complete information about the schedule and duration of the trial, directions to the trial location, and the name of someone you can contact with questions or problems at anytime.
How am I protected as a clinical trial participant?
As a participant under a doctor’s supervision, you are protected by the same laws and ethics that regulate the medical profession. Informed consent helps protect you by making sure you have been given all the necessary information about a trial. As a volunteer participant, you have the right to discontinue a trial for any reason or for no particular reason at all.