What is it like to participate in a study?
The journey of a volunteer in a clinical trial
By Mary Drake, Innovenn, Inc., president, CEO
Clinical trials are a key part of the foundation for creating life-saving advancements in health care that depend on the participation of volunteers from all walks of life. You may be a perfectly healthy person or someone battling cancer, but your participation in research is vital to new discoveries. Researchers could not make advances without the valuable contributions of volunteers who participate in clinical trials.
If you are considering volunteering to participate in a clinical trial, it is important to learn as much as you can about the process and your rights as a volunteer. Even though the experience for participants may be different from trial to trial, there are a few things you should know about before you volunteer.
What is a protocol?
Each trial must follow a protocol, which is a document that governs the science behind the trial. This includes, study objectives and methods; the procedures: frequency of visits to the study site, and data collected (e.g., medical history, blood samples, symptoms, etc.) and important steps to ensure your rights and safety are protected.
The protocol also details the treatment the volunteer will be given and the setting where data will be collected such as a hospital, clinic or doctor’s office. Some data may be collected at home. In those instances, volunteers are usually required to keep logs or diaries (sometimes on phone apps) and then periodically return to a clinic or doctor’s office for a checkup and to review the log or diary.
What kinds of checks and balances are in place to govern a trial?
There are checks and balances in place before and during trials to make sure that the study has scientific merit and does not unduly put a volunteer at risk. One such check and balance is the review of a protocol by an outside ethics committee.
The outside, independent ethics committee, called an institutional review board, or IRB, can be a company, research institution or government research agency. Most United States clinical trials are required to have an IRB, according to the National Institutes of Health (NIH). The exceptions include educational settings (e.g., curriculum evaluation, surveys), taste and food testing, and consumer acceptance studies.
The IRB’s purpose is to ensure that clinical trials are ethical and that your rights are protected, the NIH states. Board members typically include doctors, statisticians, and community members.
An IRB will only approve research that deals with medically important questions in a scientific and responsible way. It also provides scientific oversight and guidance at various stages throughout clinical trials. IRBs review and approve trials requiring oversight before the trial can begin.
The federal government also provides protection for clinical trial participants through the Office for Human Research Protections, which provides oversight to IRBs.
The federal Food and Drug Administration (FDA) provides oversight for any clinical trial involving a new medicine or device.
What will happen to me if I choose to participate?
Now that you have a sense of how clinical trials are governed, let’s take a closer look at what you may experience when the trial begins.
Once you have found the trial you wish to join, you will be directed to the study site, where you may meet with a doctor who is in charge of the research (Primary Investigator), a nurse and other health care providers. Since there are many different types of trials, the procedure to enroll can vary greatly, but they do include two key components, consent and eligibility.
If you decide to join a study, you will be asked to sign the informed consent form (often referred to as the ICF) and to undergo an evaluation to determine your eligibility.
What is informed consent?
One of the most important facets of the clinical trial process is informed consent.
At the heart of the process is the informed consent form. This document outlines the risks and benefits, the treatments, procedures, frequency of visits, who to contact if you have questions or concerns, and other important things about the trial. It is designed to help you as a volunteer get all of the information you need to make a good decision about whether or not participating is right for you.
That said, this process is more than just signing a form agreeing to participate. Prior to signing the informed consent form, you have the right to speak with a nurse or doctor to discuss the trial. This discussion is crucial to thoroughly understanding the trial.
It is important to note however that the form is not a contract, so once it is signed you may quit the trial at any time without any penalty.
How do I know if I qualify to be enrolled in a trial?
Like trial location, eligibility can be different between trials, but generally includes, age, gender, type and stage of disease, prior treatments and/or other current health problems.
Eligibility criteria ensure that new approaches are tested on similar groups of people. These criteria also help keep you safe by excluding anyone for whom the treatment has known risks that outweigh any possible benefits, the NIH states. It is very important that you share your medical history and current medications with the Primary Investigator and trial coordinator for this reason.
How does a trial work?
Once you have signed the informed consent and have been deemed eligible for the trial, you will be given a treatment, drug or device to use and instructions on how and when to use them. Your data will be recorded and combined with the data of others who are also in the trial to learn as much as possible and determine if the drug or device works as intended, and if there are any safety risks.
In many clinical trials, participants are placed into one of two or more similar groups called comparison groups (cohorts). This is usually done randomly. Each group is given different medical treatments.
In a drug trial that is looking at seasonal allergies for example, one group may get the current standard nasal spray treatment for nasal inflammation, and the other group in the trial would get a new type of nasal spray. The trial’s organizers would compare the results of the treatment groups to see which drug has the better outcome.
Sometimes a new drug is compared to a similar looking harmless tablet or capsule that has no therapeutic effect, called a placebo (e.g., sugar pill). Trial organizers must tell you your chances of being given a placebo during the consent process before the study begins.
You may not be told which treatment group you are being placed into so the data can be collected without bias. In most cases, called double-blinded, not even the clinical staff and trial sponsor know in which group you have been placed until after the trial is over.
If at any time you have a reaction to the study’s treatment, drug or device (mild or severe), you should report this to your study doctor. This reaction will be recorded as an adverse event, or AE, and is reported to the FDA, the IRB and where applicable to an independent data safety committee.
What happens after the trial?
When the trial is completed you will no longer receive the treatment. However, if you have a symptom or condition related to the clinical trial after the trial ends, you should report that to the trial organizer. They will record this information as an AE along with the rest of the data collected during the trial.
The data collected during the trial is carefully analyzed and then used to determine next steps for the treatment being tested in your trial. After a Phase I or II trial the researchers decide whether to move on to the next phase or to stop testing the treatment due to safety concerns or ineffectiveness. When a Phase III trial is completed, the researchers examine the data and summarize what has been learned; the results are published in medical journals. The analyzed data from one or more trials is collectively used to support approval by the FDA when the drug or device manufacturer submits the treatment for review.
The power of clinical trials
The results of many trials become the foundation of life-saving medicines and tests to diagnose a condition. Even if the trial shows the new treatment to be less effective than current treatments, it still advances knowledge and understanding and can lead to a better solution in the future. Advances that improve how we care for patients cannot be made without the valuable volunteers who participate in clinical trials.
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