Participating in a clinical trial has many benefits, including working with condition specialists, getting access to personalized medical care, and helping science move forward — but did you know that some clinical trials offer compensation, as well?
Many people wonder if clinical trials are safe, how much they get paid and who can participate.This article covers the basics.
If you want to know whether paid clinical trials are safe or not, you need to understand how many paragraphs there are in clinical trials.
Why are clinical studies divided into phases?
Because each phase has a different goal or certain questions it is trying to answer. Knowing which phase a trial is in can be helpful, especially if you are trying to decide whether to participate.In general, phase I studies have the most potential risk, but they can also be very helpful, especially if you need access to a new treatment that is not yet available for public use.
Phase I studies are meant to find the best dosage that can be given without serious side effects. The first few people in the study will often get a low dose of the treatment and are watched very closely.If there are only minor side effects, the next few participants will get a higher dose. This continues until researchers find the dose that works best and with the fewest side effects.
Phase II studies are generally intended to study the new treatment in a much larger number of people (usually 100 to 300). The main objective is to see if it works and is well-tolerated by many people.
Phase III studies compare the new treatment to what’s currently available. Does the treatment work better—or as well—as treatments that are currently on the market? If it does not work as well, does it have fewer side effects?Do some people improve with this new treatment who did not improve with treatments that are currently on the market? Phase III studies involve large numbers of patients (300 to 3,000 or more) and are aimed at being the definitive assessment of how well the new treatment works in comparison with the current 'gold standard' treatment.
Phase IV studies take place after the Food and Drug Administration (FDA) has approved a treatment for use by the public. Phase IV studies might look at the safety of a treatment in special populations, or over a longer period of time, or address certain aspects that weren’t included in the original studies. For example, a phase IV study might want to find out if an FDA-approved blood pressure drug can also slow the loss of kidney function in people with kidney disease.
From the phase of paid clinical trials, we know that the safety of volunteers participating in the first phase is the lowest, and the safety gradually increases later.
How is the safety of clinical research participants protected?
Based on many years of experience and learning from past mistakes, strict rules are in place to keep participants safe. Today, every clinical investigator in the United States is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research.
Each clinical study follows a careful study plan, called a protocol, which describes what the researchers will do. The principal investigator, or head researcher, is responsible for ensuring the protocol is followed.
Safeguards to protect clinical research volunteers include Institutional Review Boards, informed consent, Data and Safety Monitoring Boards, and Observational Study Monitoring Boards.
●Most clinical studies in the U.S. must be approved by an Institutional Review Board (IRB). The IRB is made up of doctors, scientists, and members of the general public who ensure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants do not outweigh the potential benefits of the study.
●Informed consent also helps protect participants. Informed consent is the process by which you learn the key facts about a study before deciding whether to participate. Members of the research team explain the research before you start and throughout the study. They provide an informed consent document, which includes details about the study, such as its purpose, how long it will last, required procedures, and who to contact. The informed consent document also explains the risks and potential benefits. You are free to ask questions, request more information, or withdraw from the study at any time.
Clinical trials and studies also have committees that monitor the safety of the research as it occurs.
●Clinical trials that test an intervention are closely supervised by a Data and Safety Monitoring Board. The board is made up of experts who review the results of the study as it progresses. If they determine that the experimental treatment is not working or is harming participants, they can stop the trial early.
●Observational Study Monitoring Boards monitor the safety of observational studies with large or vulnerable populations, or risks associated with tests or standard of care.
How Pay is Determined in Clinical Research Trials
Some research opportunities offer financial compensation, while others provide reimbursement for travel, gas, and other expenses. However, it is important to understand what clinical trials are compensating for, why some trials are paid differently than others?
The amount a clinical trial pays varies for every study and is determined by many factors, including, but not limited to:
The number of in-person visits required
The number of phone visits required
Diary entry, or symptom-tracking requirements
Time for study-related exams
The condition being studied
The patient/caregiver’s burden
The length of the study
The phase of the study (earlier phase studies typically involve more risk)
Regardless of how easy it can be, participation in a clinical trial can still require time and travel, and may involve risk.Research studies often require several visits, each of which can involve payment for completion.Additionally, some studies require weekly or daily check-ins through an app (patient diary) or phone call which also involve payment.
Examples of High-Paying Research Studies
Higher-paying clinical trials may involve investigational vaccines, medications, medical devices, or tests. For example,a Phase I study for an investigational vaccine will usually pay more than a Phase III study for the same investigational vaccine. This is because Phase I studies are the first to involve human subjects, the potential side effects, risks, and benefits may not be clear.
Phase I studies may also require more of the participant’s time for visits, diary entries, or in-office exams. Inpatient studies — which require one, or more, overnight stays in a clinic — frequently pay more than outpatient studies, which only require one, or more visits.
To better understand the compensation for Phase 2-4 trials, it may help to understand the investigational product the trial is studying. For example, a trial for a potential multiple sclerosis medication may require longer visits, more intensive symptom tracking, and one-on-one visits with neurologists.
The vaccine studies in some clinic typically offer $500-$2,500 in compensation for completing all visits and follow-up requirements.
Healthy volunteers
Clinical trials with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to those taking part. Researchers take measurements and make observations. Researchers may use the data to compare patient volunteers and healthy volunteers.
Patient volunteers
Research with patient volunteers also helps develop new knowledge. Depending on how much is known about the disease or condition, these procedures may or may not benefit the patient volunteer.
Patients may volunteer for studies similar to those in which healthy volunteers take part.
Diverse volunteers
In the past, clinical trial volunteers were often white men. Researchers assumed that study results were valid for other populations as well. Today, researchers realize that women and people from different racial and ethnic groups sometimes respond differently than white men do to the same medical approach.
Children
Children need clinical trials that focus on them, because medical treatments and approaches often differ for children. For example, children may need lower doses of certain medicines or smaller medical devices. A child’s stage of development can also affect how safe a treatment is or how well it works.
Paid clinical trials play a key role in medical research while offering financial benefits to participants. However, understanding the process, risks, and application steps is crucial. Always choose reputable trials to ensure safety. Hopefully, this article helps you decide if joining a clinical trial is right for you.
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