A comprehensive explanation of Clinical trials and their benefits to cancer patients. Clinical trials can give early access to new studies and provides a source of hope for cancer survivors who can’t find the right treatment for them Clinical trials. Two words that could change your life for the better.
A Brief History of Clinical Trials
Experiments to understand how the human body reacts have been occurring for centuries. The first recorded experiment on people was in 562 BC when King Nebuchadnezzar conducted a 10 day study to observe only a meat diet vs a meat and vegetable diet! Though King Nebuchadnezzar’s study was more of an observation study, actual clinical trials have been happening since the 1700’s. In 1747, James Lind conducted a clinical trial on men with survey, testing several different diets to observe which had the best effect. It was found that oranges and lemons were most successful, therefore leading to the discovery that scurvy is caused by a vitamin C deficiency. In 1811, the placebo was introduced into clinical trials to give a more accurate result with a control group. (Bhatt) Clinical trials have come a long way since their advent. By 2020, it is projected that over 300,000 clinical trials will happen per year!
What is a Clinical Trial
A clinical trial is defined as an experiment in people to evaluating a medical, surgical, or behavioral intervention. The primary goal is to test if a new drug, diet or device would have beneficial effects on a patient. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups. Before a drug enters a clinical trial, it is tested on animals to ensure the safety of the drug. Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.
Phase I can be thought of as an entry level study. It studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.
Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study. (Center Watch)
How Bias is Removed?
There are a variety of biases which can occur during a clinical trial but it is important to understand these trials do their best to randomize the trial. Randomization
“Blinded” (or “masked”) studies are designed to prevent members of the research team and study participants from influencing the results. Blinding allows the collection of scientifically accurate data. In single-blind (“single-masked”) studies, you are not told what is being given, but the research team knows. In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias.
Benefits and Risks from a Clinical Trial
Like many things in life, clinical trials have their pros and cons. There are a few things to consider when deciding whether or not to enter a clinical trial. Pros: you have access to a treatment of a disease before it is available to the public, you may be provided medical care and more frequent check-ups as part of the trial, careful attention from some of the best cancer doctors, treatment could be free or low cost, you could be a part of helping to move science forward and help people in the future. However, it is also important to understand your potential risks that come with a clinical trial. These include but are not limited to: potential severe side effects, you insurance may not cover the costs, the new study could not work on you (even if it works on others), and not being able to choose which treatment you receive. (Breastcancer.org)
Clinical trials can be a huge benefit to both your health and financial state. They can give you access to new upcoming drugs not on the market yet. Clinical trials can also be a great way to treat cancers. Though fairly new to the cancer treatment field, clinical trials can be your way to maintain and effectively treat cancers. We are here to match you to your correct clinical trial.