Participating in a Clinical Research Trial
What is clinical research?
Clinical research is the study of health and illness in humans, in both sick and healthy people. 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 take 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
Why should I participate?
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. You may have access to investigational treatments before they are available. You may have access to free diagnostic procedures or medical tests related to the clinical trial and be compensated for your time and travel related to the trial.
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 on 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.
Frequently Asked Questions
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. You may have access to investigational treatments before they are available. You may have access to free diagnostic procedures or medical tests related to the clinical trial and be compensated for your time and travel related to the trial. Participation is always voluntary.
All clinical trials have criteria that define who can participate. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study.
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 are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
A protocol is a written, detailed plan of a study that all research sites follow. It outlines criteria that eligible volunteers must meet in order to participate in a study. Protocols also describe the schedule, procedures, medications, dosages, and length of the study.
Informed consent consists of a document and a process. The informed consent document provides a summary of the trial, including its purpose, the treatment procedures and schedule, potential risks and benefits, and alternative treatments. It also explains your rights as a clinical trial participant. If you decide to enter the trial, you give 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 alternative treatments with medical staff.
The informed consent process provides you with information to help you make an educated decision about participating in a trial. Before you make your decision, the site research team will discuss the trial. You will have opportunities to ask questions before, during and after the trial.
All clinical trials conducted in the United States must be reviewed and approved by an independent ethical review committee (called an 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 and who have no affiliation with any pharmaceutical companies.
Ethical review boards evaluate all aspects of the research trial, including the written study protocol, and make sure that it is following the guidelines and procedures required to protect the safety and well-being of patients 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. It may be helpful to write down your questions for the research team.
Yes. A participant can leave a clinical trial, at any time and for any reason. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In some clinical trials, one group of participants will receive a placebo instead of an active drug or experimental treatment. In these trials, experimental treatments are compared with placebos to assess the experimental treatment’s effectiveness.
Clinical trials are generally conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. These trials also help determine the best dosage to use.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.