What Are the Risks to Participating in Clinical Trials?
General Questions about Clinical Trials
What is a Clinical Trial?
The purpose of clinical trials is to discover innovative ways to prevent a disease, introduce new methods to treat a disease, pilot new medical technologies, or offer support for ill patients.
Researchers use clinical trials to study whether an intervention (treatment remedy) is safe and effective. In addition, they are also investigating the possibility of existing drugs offering relief for other specific conditions for which the drugs may not currently be approved by the Food and Drug Administration (FDA).
Companies use clinical trials to validate their new products safety and effectiveness before they can be approved and released for public consumption.
In short, clinical trials are the best way to usher in new medical advances to the public.
Why Should I Participate in a Trial?
There are two primary reasons people chose to participate in clinical trials.
- To help yourself. Let's say there's a new drug on the market that promises to relieve your chronic back pain without the risk of addiction. The pharmaceutical company would create a trial, inviting patients with chronic back pain. By participating, you may improve your own health condition and find an innovative treatment that you never knew existed. You will also receive a thorough evaluation (lab work and other tests), discover a new diagnosis and possibly learn why you are feeling that chronic back pain.
- To help others. Let's say you don't have any pre-existing conditions, but you feel like participating in a trial. The same process would take place except it wouldn't be benefiting your pain, it would help someone else. If this is the case, you would be considered a clinical trial volunteer who are needed to help discover a breakthrough treatment to others across the world.
What are the Risks of a Clinical Trial?
With anything, risks are a possibility when it comes to any clinical trial, depending on the trial. If you are undergoing a new drug trial, you may experience possible mild to severe side effects. There's always the chance that the drug doesn't work and nothing happens. This is called an ineffective treatment.
Are Clinical Trials Confidential?
Yes. Rest assured that your personal information, such as medical history, illness history, family history or any data you provided the trial's chief, will remain confidential unless specified differently. You would 100 percent be notified if anything is released to the public or specific government officials.
Am I a Candidate?
Each clinical trial includes specific inclusion criteria (that permits someone to participate) and exclusion criteria (that disallows someone from participating).
For example, a study that is testing a new treatment for chronic back pain, the participant would need to have chronic back pain. If a possible side effect of a drug is a heart attack, someone who has a history of heart disease in their family, would not be permitted to attend.
Interested individuals should carefully review the specific trial's provided requirements before participating.
Of course, saying yes or no is always at the discretion of the trial's leader. If you disagree with their response in either letting you in or not, you can appeal it to the overseer.
What Documents Will I Need to Sign?
For all clinical trials, you will be provided a consent document to review and sign, which is required by law to ensure you're fully aware of what you are getting yourself into. The consent form will include the possible risks, benefits, schedule, trial duration, the name of the study's doctor and contact information in case of an emergency. Following the trial or any other visits, you will most likely fill out an evaluation form, which provides the trial information about how it went for you.
Do I Get Paid for Participating?
Generally speaking, yes — it depends on the specific trial. Some companies will pay you a flat fee (decided at their discretion), reimburse for travel expenses or any follow-up appointments. Now, we are not saying that every trial provides financial gain. All costs would be discussed with you prior to you initiating the trial. At that point, you can say yes or no in participating.
Do I Have to Pay any Money for Participating?
It just depends on the specific trial, but most of the time, all medical care, including laboratory tests, medications or other equipment used, will be provided to you at no charge. Also, most of the time, you will not pay any money as you are doing the company a service for participating in the first place.
How Long Do Clinical Trials Last?
Your initial consultation normally lasts about three hours in order to properly assess if you are a good fit for the trial. The doctors want to be as thorough and detailed as possible to make sure you are approved to attend.
The duration of clinical trials vary from months to years (including follow-up assessments), depending on the type of clinical trial being conducted and whether a drug or a medical device is being tested. Upon qualification, the exact dates and length of the study would be provided to you.
Prevention clinical trials — a trial used to prevent a specific disease such as cancer — can actually last 10 to 20 years in order to evaluate the long-term implications of lifestyle changes such as exercise or diet. In this case, you would normally have to attend weekly follow up meetings with the trial's doctor. Those follow-up meetings tend to only be about 45-60 minutes.
For new drugs or devices, a more common span is about three to seven years.
Who Do I Work with During the Trial?
From support staff, such as a receptionist to doctor's assistants and board-certified doctors, you will always have a go-to contact representative to help with any questions you may have along the way.
How Can I Be Sure to NOT Get in the Placebo Group?
It's important to understand that with most clinical trials, the groups are randomized — meaning that a certain percent of clinical trial participants will not actually receive the product being tested. This is called a control group. The control group is defined as the group in an experiment or study that does not receive treatment by the researchers and is then used as a benchmark to measure how the other tested subjects do. It's also used to compare the results of the ones who actually receive the treatment. You are at the discretion of the trial's overseer whether or not you go into the control group.
Generally speaking, all clinical trials will have a group of subjects who either receive a placebo (control group), receive the currently approved standard of treatment (already approved for public consumption) and another group of participants who receive the new product. The reason for this is that the outcomes are compared to those outcomes of the group receiving the new product versus the others. If everyone received the new product, the sponsor could not make a valid comparison to find out if it actually works.
A participant may ask to be in the group receiving the new product, and it will be up to the investigators conducting the clinical trial to determine if that request can or should be honored under the clinical trial guidelines. It is typical for a randomized clinical trial to have 60 to 70 percent of participants receive the new treatment, so the odds tend to be a little better to land in that group.
What Happens if I Want to Leave Before the Trial is Completed?
The most important thing to remember is that you are volunteering for the trial — you have the freedom to leave if you see fit. Maybe you don't feel comfortable staying or are sick, whatever the reason, you can leave at any time (unless instructed otherwise).
You may be thinking, “Uh oh. I signed that consent form, does that mean I have to stay?”
The consent document is only utilized for legality purposes. Normally, the verbiage on the forms will not force you to remain in a trial. If you do want to leave before it's completed, the leaders will want to know why and may have you fill out an evaluation form, which would be used just for the trial's chief to make any improvements or adjustments based on your commentary.
If I am not Selected, Can I Still Obtain the New Treatment or Device?
In some cases, yes. The FDA sometimes enables manufacturers to provide new treatments for expanded access or continued access programs created to assist those who have a demonstrable need for an intervention but did not receive it at the trial.
Generally, expanded access to experimental treatments is granted in cases of a life-threatening or serious disease for which there is no alternative treatment, and for which the experimental treatment actually shows promise in clinical trials. In recent trials, the expanded access protocols have been used to deliver drugs for people with HIV, the virus that causes AIDS.
Continued access programs also make it possible to obtain a new medical device quickly. Continued access initiatives allow people to receive the product after the clinical trial has been fully enrolled and before the FDA has approved the product for use in the general patient population.
Is There Anything Else I Should Know?
By federal law, researchers for any trial must take four steps in order to make the study as safe as possible for yourself and the trial members. Those items include:
- A written examination about the content of clinical research and ethical responsibility of the researchers.
- Preclinical studies that show that a new investigational treatment is safe and effective in laboratory animal tests.
- Use of strict protocol – an outline prepared before the beginning of a study that describes exactly what will take place during the trial.
- A written description of all the information that you will need to make an informed decision about joining a clinical trial. The process of giving you this information is called an informed consent.
Closing It Out
Clinical trials develop necessary information and feedback about new medical products. Participants who have not been satisfied with readily available products and devices may want to consider the advantages and disadvantages of participating in clinical trials. Knowing what to expect will minimize confusion and disappointment, and we hope that this article helps answer any questions you may have about what to expect when participating in a clinical trial.