The Clinical Research Process
Clinical trials (also called “clinical studies” or “research studies”) help determine if medicines, medical devices, and tests are safe and effective.
The Clinical Trial Journey
Top Questions and Answers
Who can join a clinical trial?
Answer: Almost anyone can participate in a clinical trial.
Will I be compensated for being in a clinical trial?
Answer: Yes, most trials offer compensation.
Most Envision Trials studies offer compensation for study-related time and travel. The amount paid varies for every study. Studies often require several visits, each of which can involve payment by the sponsor.
The amount paid for participating differs among studies and depends on complexity, length of the trial, number of visits, etc. At Envision Trials, most studies do not require overnight stays.
Envision Trials is transparent about study requirements and potential compensation — you can ask about study compensation during your first phone call with Envision Trials, or you can ask during your in-office screening.
What are the potential risks or benefits?
Answer: It depends on the study.
Every effort is made to ensure the participant’s safety during a study. The ethics and laws that govern medical practice also apply to clinical trials. However, clinical trials involve investigational products that could be ineffective or cause serious side effects.
Clinical trials are overseen by the U.S. Food and Drug Administration (FDA). Clinical trials also follow strict plans called protocols, which are reviewed by Institutional Review Boards (IRBs) to make sure patient rights are protected.
Every study is different, but the informed consent of each one ensures you understand what will happen. If you are selected, you’ll learn about the product being studied, your role in the trial, potential side effects, and the visits required. In some studies, you may receive an inactive placebo. Envision Trials also conducts interview-only studies that do not involve medications.
Deciding to Participate in Clinical Trials
This video discusses types of human research with a focus on clinical trials, and explains common terms that potential participants should know.
Go to hhs.gov for more information about deciding whether to participate in research. While there, download and print a list of potential questions to ask the researchers.
Why I Participate in Alzheimer's Research - Bob's Story (Short version)
While Bob doesn’t have relatives with Alzheimer’s, he has a daughter with Down syndrome, which puts her at increased risk for developing dementia. He is a healthy control volunteer, motivated by his daughter’s condition and his love of science. He also discusses and debunks some concerns that may make potential volunteers hesitant to join a study.
Why join a clinical trial?
Get early access to new study medicines
Clinical studies offer more care options for patients suffering from common, unique, and rare health conditions.
Help move science forward
Clinical studies offer a way for almost anyone — regardless of their background — to help improve human health and wellbeing.
Receive compensation if you qualify
Most Envision Trials studies will compensate for time and travel thanks to the sponsors. We'll let you know what to expect during your first phone call with Envision Trials.
Give hope to people worldwide
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
1: Joining a clinical trial
To apply to participate in a clinical trial, you can either enter your information on the forms on every study page or contact us. No matter how you contact Envision Trials, an enrollment specialist will be available to answer questions and find the most suitable study for you.
2: After you apply
The information provided will be reviewed, and the subjects will be selected. We will contact you through the route of your choice, to let you know the step to follow and also, you can clarify all the doubts that may arise; In case you are not selected for that specific clinical trial, you may be taken into account for future projects.
3: After you’re accepted
After a successful phone screening, you will visit a Envision Trials clinic for a physical screening. You will need to bring identification information to confirm your identity and medical history. This is required for every study, and is for your safety.
4: Informed consent
5: Getting screened
6: Medication administration
When you are given an investigational medication (or placebo), Envision Trials' clinical staff will closely monitor your health. You may undergo additional tests to assess the medicine’s effect and/or to safeguard your health. The Envision Trials clinic is staffed by healthcare professionals who make your safety a top priority.
8: Following up
Some studies require several visits to the clinic. You may be eligible to receive compensation for your time and travel for each visit. Any follow-up necessary for the study would be detailed in the informed consent process so you’ll never be surprised by what a study entails.
What is a clinical trial?
Who pays for clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in various locations, such as hospitals, universities, doctors’ offices, or community clinics.
Who can participate in a clinical trial?
What should people consider before joining a clinical trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people can participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
How is my safety protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
What are the phases of a clinical trial?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
What is a control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
Does a participant continue to work with a primary health care provider while in a trial?
Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. 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.
Will my privacy be protected?
Yes. All medical records and research materials that identify you will be held confidential so far as permitted by law. Only individuals with study affiliation will have access to your personal information