Last Updated on February 6, 2023
What are Clinical Trials?
According to World Health Organization (WHO), clinical trials study new tests and treatments and evaluate their effects on human well-being and health. These trials involve experimental drugs, devices, and procedures on volunteers. They may be a ray of hope for many and could potentially help future generations. Before participating in clinical trials, one must wonder, are clinical trials safe?
This blog may help understand the possible benefits and risks associated with clinical trials, their importance, and whether to partake in clinical trials.
Importance of Clinical Trials
A clinical trial is to be thanked for every breakthrough in the world of medicine and health care. Clinical trials are essential in developing new treatments and adding value to existing ones. Clinical trials can only test the usefulness and success of a new treatment.
A medicine may go through years of laboratory testing, followed by animal testing, before being approved for human use in clinical trials. A clinical trial has four phases. To better understand the question, “are clinical trials safe?”-knowledge of these phases may be of immense help:
PHASE I:
By participating in clinical trials phase I, participants can access the newest available treatment that is not yet available to the general public. Low doses are administered to determine the most suitable dosage.
PHASE II:
In phase II, the focus is directed toward a larger audience (about 100-300 individuals). This phase aims to test the treatment tolerance in more people.
PHASE III:
This is a vast and comprehensive phase where tests involve more than 300 people (but can be more than 3000). Positive changes in the quality of life, possible side effects, and improvement in the currently available therapies are evaluated.
Phase IV:
After Food and Drug Administration (FDA) approval, these studies enter phase IV. The possible long-term effects are tested in this phase. The safety of special populations is considered, and certain features that may have been left out are incorporated.
The Possible Risks
To answer the question, “are clinical trials safe?”, one must understand that the potential risks from clinical health trials are rooted in the relative newness of treatments. Those interested participating in clinical trials are informed about the possible side effects of the study treatment beforehand and the research staff educated the participants on how safe the clinical trials are. Most clinical health trials cause only minor discomfort which lasts briefly.
Regulation of Clinical Trials
Congress has passed laws to minimize the risks and to protect the participant’s rights. The clinical investigators must monitor and ensure the safety of each participant. Researchers have to follow strict rules which the federal government enforces.
Institutional Review Board (IRB):
The Institutional Review Board is responsible for approving and reviewing most of the research plans in the United States. They make sure participants’ safety is prioritized and that the clinical trials are safe enough. They check to see if the practices are legal, ethical, and well thought out. Every research institution has an IRB of its own.
According to the National Cancer Institute, IRBs include:
- Scientists
- Doctors
- Clergy
- Patient advocates
Data and Safety Monitoring Committee (DSMC):
In addition to an IRB, there is also a Data and Safety Monitoring Committee. Specialists who can better understand a condition formulate this committee. Members of the DSMC are not associated with the sponsor or institution. All phase III clinical health trials require DSMC approval.
Food and Drug Administration (FDA):
The Food and Drug Administration approves new medicines or medical equipment before studies begin in human beings. It lets us know “are clinical trials safe with these new medicines?”. FDA verifies adherence to proper consent and protocol. It is necessary to have FDA approval before phase III clinical health trials begin.
Office for Human Research Protection (OHRP):
The Office for Human Research Protection protects the rights and well-being of individuals participating in clinical trials. It provides guidance for developing educational material, oversees the IRB, and offers advice.
Patient Rights and The Informed Consent Form
FDA states that all clinical health trials must obtain informed consent from the participant. the informed consent contains details of:
- The purpose of the study
- Information about the procedures
- Possible benefits of taking part
- Possible risks or discomfort
- Whether or not are clinical trials safe
- The protocols
- The duration of the treatment
- Details about the research team
- Associated costs with the treatments
- Possible alternatives
After thoroughly going through the informed consent form you can better understand the technicalities. Since the informed consent form is not a binding agreement, you have the option to end it at any time. If the question “are clinical trials safe?” or “are clinical health trials safe?” still bothers you, the next section can give you good reasons to participate.
The Benefits of Participating
There are numerous benefits of partaking in clinical trials:
- You may be among the first people who gain access to treatments that may not be available in the market for many years
- One can get more frequent access to healthcare facilities and personnel including doctors or nurses
- The participants get a chance to actively take part in their own healthcare
- An individual can have the opportunity to help others receive treatments in the future
- You may be able to get information about support groups or other resources
Diversity in Clinical Trials
Are clinical trials safe for every ethnicity?
The FDA always encourages people from underrepresented and historically marginalized communities to take part in clinical research because treatments affect people of different backgrounds differently.
The volunteers for clinical health trials don’t always reflect the diverse U.S. population. Trial groups should be multiracial, of multiple ethnicities, and from diverse socioeconomic backgrounds. Furthermore, an FDA study of more than 100,000 U.S. clinical trial participants from 2015 to 2019 showed that 78% of people were caucasian and 79% were over the age of 65.
The Takeaway
The answer to the question of whether or not are clinical trials safe is for you to decide. But one must understand that clinical trials are essential to medical research since they provide important details about the efficacy of treatments and their effects on the welfare of different populations. They are not completely risk-free therefore there are mechanisms in place to ensure the safety of all participants.
It is always advised to review the consent form thoroughly, report any adverse effects, properly follow instructions, be aware of your rights as trial participants, and participate actively. In conclusion, the idea of ‘are clinical trials safe’ might seem alarming at first but it may lead to new discoveries that may benefit humanity in the foreseeable future. Above all, it can give you a chance to contribute to medicine and give you early access to new treatments.
