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Understanding Clinical Trials & New Treatment Options

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By: Serena Tanner Edited by: Alyssa Hill Subject Matter Expert Reviewed by: Brindusa Vanta, MD 14 cited sources Updated Aug 30, 2024
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When you receive medical treatment, you trust that it’s safe and effective. However, to verify the effectiveness of a treatment or medication, it must first go through experimental clinical research. Those who participate in these trials pave the way for medical advancements, expanding treatment options. 

People who participate in clinical trials often do so because they have a condition that requires treatments that are not yet medically approved. If you choose to participate, you may receive cutting-edge treatments before anyone else, while being carefully monitored by the research team[1]

Of course, there’s always a risk when you choose experimental treatment options. However, for many with terminal or life-limiting diagnoses, the potential benefits often outweigh the risks. 

Key Takeaways

  • Clinical trials allow researchers to evaluate the safety and effectiveness of experimental treatments.
  • People of all ages, backgrounds, and health statuses play a key role in clinical trials.
  • You should work closely with a healthcare provider to determine if a clinical trial is right for you.

What Are Clinical Trials?

A clinical trial examines how a specific medical procedure affects its recipients. These studies allow researchers to determine how effective or safe a treatment is in humans. They can evaluate medical, surgical, and behavioral interventions to determine effectiveness[2].

One of the largest and most expensive phase III clinical trials ever conducted was in the 1950s. Known as the Polio Field Trials, this trial involved 1.8 million participants in North America and 10 million in Russia. Scientists found good evidence that Jonas Salk’s killed virus preparation was 80-90% effective in preventing paralytic poliomyelitis.

Dr. Brindusa Vanta, MD

How Do Clinical Trials Work?

Clinical trials progress through four phases before the FDA approves a treatment for widespread use. Phase 1 trials are typically much smaller and are used to determine safety and dosage. They usually test an experimental treatment on 20 to 80 people, which helps identify any side effects the treatment may have. In many cases, pharmacological treatments are tested on healthy volunteers to determine how the body interacts with the drug. However, some phase 1 trials utilize terminally ill patients.

Phase 2 trials usually involve 100 to 300 people. During this phase, the treatment is tested on those with the condition or disease it’s designed to address. Researchers continue to evaluate safety and side effects. This stage also helps determine dosage. In many cases, these trials are randomized, and volunteers receive the experimental dose, a placebo, and sometimes a standard treatment for control.

In phase 3, trials range from several hundred to several thousand people to gain further insight. Data obtained during this phase is also compared with other approved treatments to assess its effectiveness. If the results in phase 3 pass FDA review, the experimental treatment will receive approval for widespread use[3].

After receiving FDA approval, phase 4 trials enable larger, more diverse populations to use the treatment. This allows for further effectiveness and safety evaluations and, in some cases, may reveal side effects that weren’t apparent in smaller sample sizes[4].

Phase IV studies, also known as post-marketing surveillance trials, continue to assess the efficacy and safety of drugs, closely monitoring suspected adverse drug reactions and detecting rare adverse reactions. Other goals of Phase IV trials include fulfilling regulatory requirements and supporting new indications for the drug.

Dr. Brindusa Vanta, MD

Knowing which phase a trial is in can provide insight for prospective participants. It can help them determine if they qualify to volunteer and understand the level of risk involved. 

Who is Eligible to Participate in Clinical Trials & Experimental Treatments?

Generally speaking, anyone can participate in a clinical trial if they meet the eligibility criteria. Researchers need diverse populations to test the efficacy of treatments, which means a mix of ages, health statuses, and backgrounds.

However, some studies have more stringent eligibility criteria. They may require patients to have specific conditions. A clinical trial’s protocol outlines eligibility criteria, and these vary from trial to trial[5].

If you’re interested in participating in a clinical trial for a specific condition, speak to your care team. They will help you understand the risks and potential benefits of the trial and determine if you’re a good candidate[6].

How to Find Clinical Trials Near You

If you’re a good candidate, your doctor may be able to refer you to a clinical trial. However, if you prefer to search for clinical trials on your own, ClinicalTrials.gov offers a database of federally and privately supported studies performed around the world[7]. It also provides information about the trial’s purpose, eligibility criteria, location, and contact details[8].

Before contacting the trial coordinators, gather your medical records in advance. The coordinator will likely screen you to determine if you meet the eligibility criteria. Likewise, compile a list of questions you might have about the clinical study, such as[9]:

  • How long is the study?
  • Why do researchers think this treatment will be effective?
  • Who has reviewed and approved this treatment?
  • Who sponsors the study?
  • How is safety monitored during participation?
  • What types of procedures or tests will I undergo during the study?

Common Clinical Trial FAQs

How Long Do Clinical Trials Take?

The length of a clinical trial varies depending on the specific study and its research phase. Generally speaking, phase 1 trials last several months. Phase 2 can last several months or up to 2 years. Phase 3 can last between 1 and 4 years. Phase 4 trials last for several years[10].

How Much Do Clinical Trials Pay?

There’s no hard-and-fast rule about how much clinical trials pay. Not all clinical trials offer volunteers compensation either. However, those who pay typically do so based on the phase of the trial. A 2021 study of 131 participants found that the median clinical phase 1 trial compensation was around $3,070[11]. For a more specific answer, speak with the coordinator of the study you’ve chosen to participate in.

What is Informed Consent?

In a clinical trial, informed consent requires researchers to explain certain details about the trial upfront before a subject participates in it. Prior to enrollment, each subject must be informed that they are participating in a study involving research, as well as extensive information about expected procedures, risks, policies, and other details about the study[12].

How is My Safety Protected During a Clinical Trial?

In part, the informed consent process helps protect your safety by ensuring you understand the study, its risks, and your rights[12]. Beyond that, careful medical review and ongoing monitoring during the clinical trial help keep subjects safe[13].

What Are the Possible Risks and Benefits?

The possible risks and benefits vary greatly based on the scope of the clinical trial. However, side effects can occur, or participation may be inconvenient.

Certain tests, such as X-rays, can also increase the risk of cancer. In other cases, an experimental treatment could lead to side effects ranging from mild to severe, or it may not work at all[14].

However, generally speaking, all clinical trials help medical advancements and make treatments accessible to more people. Likewise, you could benefit from access to an effective treatment before it’s readily available to the public.
You should receive details about the risks and benefits of a clinical trial during the informed consent stage.

Clinical Trials Save Lives

Clinical trials play a crucial role in advancing medicine. Just because a condition can’t be treated now doesn’t mean it will never be treatable. Participating in clinical trials saves lives by helping new treatments receive FDA approval. If you choose to enter one, you’ll be joining thousands of other like-minded people dedicated to a better tomorrow.

Alternatively, clinical trials can benefit you if you currently have a serious condition that has no approved treatment, you’ve exhausted all other existing treatment options, or the side effects with other treatments have proven too detrimental to continue with. Be sure to work closely with your healthcare provider to make informed decisions about your health prior to participating.

Written by Serena Tanner

Serena Tanner attended the University of Washington, where she earned a degree in philosophy after many detours delving into human rights, law, psychology, and social work. Health and holistic wellness topics continue to hold a special place in her heart. When she's not reading or writing, she can be found exploring the Pacific Northwest with her two children and dogs.


Edited by Alyssa Hill

Alyssa Hill is an experienced editor and health writer. She holds an M.A. in journalism from the University of Arizona and is also a certified somatic practitioner. A former content manager for multiple start-ups in the marketing and health/medical industries, Alyssa has extensive experience writing medically accurate and well-researched content, editing articles for clarity and SEO, adhering to strict guidelines, and ensuring all content is up to standards.


Subject Matter Expert Brindusa Vanta, MD

Dr. Brindusa Vanta is a healthcare professional, researcher, and medical subject matter expert . She earned her MD degree from "Iuliu Hatieganu" University of Medicine, Romania. She has a special interest in mental health and has collaborated with psychologists and other mental health practitioners on various research projects focused on therapies to manage depression, age-related cognitive decline, trauma and stressor- related conditions.

Sources

  1. National Cancer Institute. (n.d.). Why participate in a clinical trial? Sourced from https://www.cancer.gov/research/participate/clinical-trials/why-participate

  2. National Institute on Aging. (n.d.). What are clinical trials and studies? Sourced from https://www.nia.nih.gov/health/clinical-trials-and-studies/what-are-clinical-trials-and-studies

  3. University of Cincinnati College of Medicine. (n.d.). Trial phases 1, 2, 3 defined. Sourced from https://med.uc.edu/depart/psychiatry/research/clinical-research/crm/trial-phases-1-2-3-defined

  4. National Cancer Institute. (n.d.). Phase IV clinical trial. Sourced from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/phase-iv-clinical-trial