What is a clinical trial?
A clinical research trial is a scientific study that helps determine how a new medicine or treatment works in humans. Clinical research trials are conducted to obtain information used to determine the safety and effectiveness of a new drug, device, or treatment. The US FDA must review information from these clinical trials and then decide if the drug, device, or treatment should be approved and made available to patients in the market. The FDA has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.
Who’s involved in a clinical trial?
Participant
You or a family member! Our participants are at the heart of what we do.
Site
Our offices. Participants will visit our office to complete study tasks.
Study Coordinator
The study coordinator will work closely with the study participants and they will be able to answer any questions related to participating in a clinical trial.
Study Doctor
Also called the Principal Investigator, the study doctor is responsible for participant safety and wellbeing during the trial.
About Clinical Trials
Participation and Safety
Clinical research is the study of health and illness in humans. It focuses on improving knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care. Clinical research trials are carefully designed, reviewed and completed, and must be approved before they can start.
All clinical research must:
- have the goal of increasing medical knowledge
- be carried out by competent persons taking all necessary measures to protect those who lend themselves to research
- obtain regulatory approvals and take all the necessary legal and ethical steps
- collect the consent of those involved in research
Clinical Trials are a crucial part of finding new medicines and treatments for diseases. There are many reasons why people volunteer to participate in clinical trials. You may have:
- the opportunity to play a role in the development of new treatments, devices or preventions for certain diseases or medical conditions
- access to investigational treatments before they are available
- access to free diagnostic procedures or medical tests related to the clinical trial
- you may be compensated for your time and travel related to the trial
Anyone can be considered for a clinical trial however each trial has a criteria that says who can participate. The factors that allow someone to participate in a clinical trial are called the “inclusion criteria” and those that don’t allow someone from participating are called the “exclusion criteria”. These criteria are based on factors like age, gender, type and stage of a disease, previous treatment history and other medical conditions.
Some research studies seek participants with specific illnesses or conditions while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria is used to identify appropriate participants considering participant’s safety and the study coordinators will be able to answer any questions related to the study.
Financial Questions
Patients generally do not have to pay out-of-pocket costs for treatments studied as part of a trial. Every trial is different, but the clinical trial’s sponsor usually pays for all research-related costs.
Clinical trials may include compensation for your time. The amount will vary from trial to trial.
Yes, you are encouraged to continue seeing your PCP. We will notify your PCP of your participation in the trial. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
General Trial Questions
The informed consent document provides a summary of the trial, purpose, what will happen during the trial and when, potential risks and benefits and alternatives to participation. It also explains your rights as a clinical trial participant.
If you decide to enter the trial, you are required to provide your official consent by signing the document. Even after signing the informed consent, you may leave the trial at any time and are given the opportunity to discuss the other treatments with medical staff.
Before you sign the document, the research team will provide you with information to help you make an educated decision about participating in the trial. You will have opportunities to ask questions before, during and after the trial. You don’t have to participate in a trial if you do not want to.
All clinical trials conducted in the United States must be reviewed and approved by an independent ethical review committee (called the Institutional Review Board) prior to starting and throughout the duration of the trial. These review boards are made up of people from a variety of professions such as doctors, teachers, and religious leaders, who have no affiliation with any pharmaceutical companies.
Ethical review boards evaluate all aspects of the research trial to make sure that it is following the guidelines and procedures required to protect the safety and well-being of participants who volunteer for clinical research trials.
If you are interested in participating, you should know as much as possible about the clinical trial. You should feel comfortable asking the members of the research team any questions about it, including the care expected while in a trial, what you should expect during any study visits etc. It may be helpful to write down your questions for the research team.
Yes. You can leave a clinical trial at any time and for any reason. There is no penalty to you and it does not affect the care you receive from your usual doctor. When withdrawing from the trial, please let the research team know about it and the reasons for leaving the study.
Randomization means participants are assigned at random into groups that receive different treatments. This is how scientists can know whether new treatments work. Sometimes a participant is randomized into a ‘control group’ that receives no active treatment or a medication already in market depending on the trial and this will be compared against a participant who receives the medication being investigated as a part of the treatment group. A study staff member can tell you more about the different groups in your trial.
