What Is a Clinical Trial and Why Do Such Trials Exist?
As increasing numbers of people suffer from obesity and health conditions related to it, it is necessary for medical professionals and scientists to continue to improve current treatments and to develop new treatments for obesity (Cefalu et al, 2015; NIH, 2017a; NIH, 2017b).
To tackle this challenge, the medical community relies on a research process that ensures that the best ideas and treatments make their way into practice. The medical community uses the knowledge and experience to pioneer new treatments and to improve patients’ health and quality of life. New ideas are called hypotheses; if it is one idea it is called a hypothesis. A hypothesis is an idea that medical professionals and scientists believe to be true based on their knowledge. It can be thought of as a well-thought-out educated guess that can be tested to determine whether the hypothesis is correct (e.g., by designing and carrying out carefully planned experiments called clinical research trials). A clinical research trial is a research study that evaluates new ways to prevent, detect, or treat disease using a drug or therapy (NIH, 2017b). Clinical trials are particularly important to the future of obesity treatment because they are considered the best type of study for establishing a cause-and-effect relationship; therefore, they are the best way to prove that new drugs or treatments for obesity are effective. Clinical trials offer participants the opportunity to gain access to new treatments (e.g., medications, treatment strategies) that might benefit the participants by helping them to lose weight or improve their health in other ways. It is important to note that clinical trials can also expose participants to certain risks. As a result, clinical trials take place in phases.
What Types of Clinical Trials Are Being Conducted to Assess Weight Loss?
Many clinical trials are being conducted on lifestyle modification (NIH, 2017b), pharmacotherapy (drug treatment) (Hassan et al, 2016) (Butsch, 2015), and weight-loss surgery (Gadde & Pritham Raj, 2017). In addition, clinical trials are evaluating the optimal combinations of these treatment modalities (Roslin et al, 2015). Moreover, there are many clinical trials in progress or being proposed for weight loss. These include, but are not limited to, clinical trials that influence the bacteria inside the digestive track and that influence brain pathways through brain stimulation; these studies hope to increase our understanding of how we can use genes to tailor weight-loss treatments (Bof et al, 2017; Corella & Ordovas, 2013; Epstein & Wrotniak, 2010).
What Are the Phases of Clinical Trials?
There are different phases of clinical trials. The first phase of a clinical trial contains the smallest number of people and then builds up to the final phase, which contains the largest number of participants. Studies are run in phases so that different questions can be answered during each phase (Gobe et al, 2017).
Phase I trials comprise about 20 to 80 people and are used to test an experimental drug or treatment for the first time to evaluate its safety and to see whether there are any side effects.
Phase II trials comprise about 100 to 300 people and are used to test the effectiveness of an experimental drug or treatment and to continue to test its safety.
Phase III trials comprise about 1,000 to 3,000 people and are used to confirm the effectiveness of a drug or treatment. It is conducted to look for side effects and to evaluate the drug or treatment in comparison to standard treatment or to similar treatments. This size trial is also used to collect data to determine how to use the drug or the treatment safely.
Phase IV trials are conducted after a drug or treatment has received US Food and Drug Administration (FDA) approval and has become available to the public. The drug or treatment’s optimal use, safety, and benefits continue to be evaluated in this phase.
What Are the Potential Benefits and Risks of Participating in a Clinical Trial?
Clinical trials allow participants to do the following:
- Gain access to new drugs or treatments before they are available to the public
- Provide regular monitoring by doctors and other medical professionals
- Allow patients to make decisions about their health care based on their decision to enroll or not
- Provide an opportunity for participants to help others by furthering medical knowledge (NIH, 2017b)
Clinical trials can expose participants to the following:
- Clinical trials can involve interventions that cause side effects (that are generally mild and temporary but can be unpleasant). However, even with routine medical care as well as with day-to-day life, serious side effects can occur; fortunately, the chances of this happening are rare.
- Studies might require a longer time commitment and other burdens that might include, but are not limited to, more treatments, more time in a hospital, more blood work, and detailed dosing of experimental medications.
Who Is Eligible for a Clinical Trial?
Clinical trials for obesity and related illnesses enroll both patient volunteers and healthy volunteers. Patient volunteers have obesity and/or a related medical condition, whereas healthy volunteers have neither obesity nor a related illness. Healthy volunteers are included in some clinical trials to serve as a comparison and are often selected based on another similar characteristic (e.g., age, gender) to participants in the study (NIH, 2017b).
Clinical trials for obesity drugs might vary in who they can enroll based on different inclusion and exclusion criteria that are based on a variety of factors (e.g., age, gender, disease status, treatment history).
Inclusion criteria are characteristics of participants that must be true for them be included in a clinical trial. For example, if the inclusion criteria for a clinical trial include being older than 18 years of age, all participants in that clinical trial would need to be older than the age of 18 years. For a trial on obesity, a study might want to enroll only individuals who have obesity (classified as a body mass index [BMI] equal to or greater than 30).
Exclusion criteria are characteristics of participants that must not be true for them to become study participants. For example, if the exclusion criteria for a clinical trial wanted to exclude patients younger than 18 years of age, all participants in that clinical trial would need to be 18 years or older. For a trial on obesity, a study might exclude individuals who do not have obesity (i.e., having a BMI equal to or greater than 30).
Why Should I Enroll in a Clinical Trial?
You should enroll in a clinical trial if you think participation in the clinical trial will be of benefit to your health or will benefit you in some other way and if these benefits outweigh any risks that might be involved with the clinical trial. Participants and/or their guardians need to make this decision freely, but the study staff has a duty to fully explain clinical trials and what they entail so that you can make an informed decision (NIH, 2017b).
What Is Informed Consent?
Potential participants in research studies must be given all of the key facts about a clinical trial before they decide whether to participate. Informed consent is a process in which potential participants are given the relevant information about the study so that they can decide on their involvement. This process should be ongoing throughout the study. A key component of the informed consent process occurs at the beginning of the study when participants read, sign, and are given a copy of a document called the consent document. This document details all relevant information about the study, including the risks and benefits of the study. Signing the document is not a binding agreement to participate in the study, and participants can leave the study at any time and can refuse drugs or treatment at any point.
What Is a Placebo and Could I Receive It?
Although most trials compare a new drug or treatment to another available drug or treatment, some clinical trials administer an inactive drug or treatment that resembles the test drug or treatment during a part of the study. This inactive drug or treatment is called a placebo. Placebos are used because they are the most effective way to show that a new drug or treatment has a therapeutic effect (by comparing the results of the placebo group with those of the experimental drug or process). Placebos are not used if their use would put a participant at risk, and you will be told before the study about whether you could receive a placebo.
Depending on the study design, you and the study staff might not know during the study whether you are receiving the actual test drug or treatment. This process is called blinding and is done to keep the knowledge of which drug or therapy participants are receiving from influencing their outcomes.
Where Are Clinical Trials Conducted?
Clinical trials might be conducted in a variety of settings, including hospitals, doctors’ offices, universities, and community clinics. The location often depends on who is conducting the research study.
Who Pays for a Clinical Trial?
Sponsors pay for some or all of the costs of clinical trials. Sponsors might be an organization or an individual, and they can include medical institutions, federal agencies, physicians, voluntary groups, and/or pharmaceutical companies. Some costs of a clinical trial might be billed to participants’ insurance companies, if these expenses are part of their normal care, and some expenses might be billed to individuals, depending on the study. You can find information on who is paying for the trial in the consent document.
What Questions Should I Ask Before Joining a Clinical Trial?
All participants should feel comfortable asking the study team any questions they might have before joining a research study. Some additional questions modeled after the US National Institutes of Health (NIH) suggested questions are included here, as well, and many of the answers to these questions can be found in the consent document (see Table 13-1).
What Happens When a Clinical Trial Is Complete?
After a clinical trial has been completed, the study staff does a careful analysis of the data they collected to determine the meaning of that data and what future testing they might choose to conduct.
The phase of the trial dictates what happens after a clinical trial:
- After a Phase I or Phase II trial, the data collected is used to decide whether to move on to the next phase of trials, based on whether the drug or treatment is safe or effective.
- After a Phase III trial, the data is analyzed to decide whether the results have medical importance.
The results from clinical trials are generally published in peer-reviewed scientific journals. Peer review is a process in which experts in the field review the data, the analysis, and the conclusions that are drawn from the trial before the results are published to make sure that the research is valid. Sometimes, results are discussed at scientific conferences, among the medical community, and in the media, if they are of importance to the general public. If a new drug or treatment is proven to be safe and effective in a clinical trial, it might go on to become a part of standard care for a disease or condition.
Should I Try Weight Loss Supplements?
Although Americans spend billions on them, published research shows that supplements and alternative therapies do not help adults lose weight, according to a study published in Obesity, the flagship journal of The Obesity Society (TOS).
In the study, researchers reviewed a comprehensive review of 315 existing clinical trials on weight loss supplements and therapies. They found most of the trials failed to show weight loss among users of the supplements.
In the future, the supplement industry and academics need to work together to design high-quality clinical trials of weight loss supplements.
TOS decided that it was important to evaluate and provide scientific evidence to guide its membership, despite the NIH’s Office of Dietary Supplements’ significant contributions to the field by evaluating information and stimulating and supporting research.
That said, when used as part of a healthy diet and lifestyle, there is still some evidence that natural fat burners may accelerate weight loss by either increasing metabolism or decreasing appetite.
For example, an analysis of six studies found that people who took green tea extract and caffeine burned 16% more fat than people who took a placebo.
Resurge is of the most popular weight loss supplements that promise to help you shed pounds and sleep better. Because studies have shown that sleep deprivation is associated with deficiencies of growth hormone and elevated levels of cortisol, both of which contribute to obesity.
While other supplements promote nutritional factors, meal replacement forms, appetite suppression, or similar effects, Resurge boosts your body’s metabolism by increasing your core temperature. However, before making any purchases, you might want to read some Resurge reviews because the supplement industry is rife with scams.
It should be noted that pills or supplements are usually not recommended for children, pregnant and breastfeeding women because some of their ingredients e.g. caffeine can have serious side effects when consumed in large amounts. For example, if a pregnant woman consumes over 200 mg of caffeine per day, her baby is at an increased risk of fetal growth restriction and/or miscarriage, though caffeine can boost your weight-loss efforts.
Although the formula of Resurge doesn’t have any stimulants, you should still talk with your doctor before you start taking the supplement, especially if you have health concerns.