Ten Prime Cancer Clinical Trial Mythologies Smashed

Ten Prime Cancer Clinical Trial Mythologies Smashed

Clinical trials provide early access to treatments, contribute to medical knowledge about a condition, help guide future research, and have the potential to impact how people with the same condition are treated in the future. We recognize that — for many people — the decision to participate in a clinical trial is a daunting one, so we thought we’d take this opportunity to debunk a few common clinical trial myths.

People have a lot of misconceptions about cancer clinical research trials. They might think patients mostly take sugar pills instead of receiving actual treatment.  Or they may think clinical research studies are only for people who have no other options.

The list of Top 10 myths that they frequently hear about clinical trials and set about shooting them down one by one:

Myth 1: Participating in clinical research provides no benefit to me as the patient

Clinical trials can give patients access to the latest medicines and procedures. Studies show that patients who participate in clinical trials have outcomes at least as good, if not better, than the general patient population. In some cases, clinical  trials are a last resort — there are no other treatments, or other interventions haven’t worked or have stopped working. But many times they involve an addition or adjustment to a standard treatment plan that may provide patients with a better quality of life.

Clinical trials may be available for patients at every stage of their disease, including newly diagnosed patients, as well as those who have exhausted some or all of the available treatment options. Before making any decisions about your treatment options, it’s important to talk to your doctor.

In fact, trials give patients access to the latest drugs and procedures. Studies show that patients who participate in clinical trials have outcomes at least as good, if not better, than the general patient population.

Myth 2: My doctor can tell me whether or not to consent to clinical research

A physician’s job is to help a potential clinical research patients weigh the pros and cons and otherwise educate them.  Your doctor can’t give you a “yes” or “no” answer or try to predict whether a particular treatment will work or not. Instead, think of your doctor as a helpful resource in making an informed decision.

Before deciding whether a trial is an option for you, or someone you care about, it’s important to learn everything you can. While they may be a good choice for some people, clinical trials may not be the best option for everyone. You should always talk to your doctor or healthcare professional who will help you make the right choice for you.

Myth 3: Researchers treat patients like guinea pigs

Before medicines can be approved for use, they must undergo extensive clinical research to ensure they are safe and effective. Each trial is conducted according to a carefully designed plan, known as a protocol, that safeguards you and other participants, and seeks to answer very specific research questions.

Investigational medicines are researched extensively in a laboratory before they are ready for clinical trials with human volunteers. Strict eligibility criteria based on individual characteristics prevent people that would not receive benefit or who may be at risk of developing adverse side effects from participating in the trial. The criteria also ensure that the outcome is the result of the new treatment or procedure and not just chance. Although researchers cannot guarantee outcomes, a patient’s safety is always the top priority.

This is far from the truth”. Often, patients will not even feel like they are part of a study because clinical trials incorporate the best available medicine. Researchers will then adjust treatment to see if enhancements can improve patients’ quality of life or response rates.

Myth 4: Clinical research patients are taking sugar pills

The comparison treatment you receive, whether placebo (an intervention with no active ingredients or therapeutic effect) or an existing medicine, depends on the type of trial. Clinical trials may compare a new therapy to one that is already available, to a placebo that contains no active ingredients, or to no medicine at all. The comparison group that does not receive the investigational medicine is known as the “control” group and they are used to determine how effective the new intervention is when compared to current practice.

In studies where there is no available treatment, or where the condition isn’t life-threatening or debilitating, the control group will receive a placebo.  While many clinical studies today don’t give patients a placebo, informed consents are very clear, and you would be made aware before enrolling in a clinical trial if there was a possibility that you might receive a placebo. In the case of life-threatening or debilitating conditions, such as cancer, patients either receive the current standard of care or the investigational treatment — i.e., they do not receive a placebo. Placebo is only used where a standard of care has not been established or there is no existing treatment for the disease. This approach allows researchers to determine the potential impact of a new intervention without withholding treatment.

Researchers never use sugar pills in place of the best known treatment for a given cancer, and they are very rarely used in clinical cancer trials whatsoever. “Patients who join clinical trials will never sacrifice quality of care.”

Myth 5: Health insurance won’t cover the cost

Check with your carrier but the chances are good that coverage will extend to the full cost of your treatment.

Myth 6: Cancer clinical research studies are for people who have no other options

Sometimes clinical trials are a last resort. But many times they simply involve a simple addition or adjustment to a standard treatment plan that can provide patients with a better quality of life.

Myth 7: You need to live near a major hospital to participate

Many clinical trials take place at regional hospitals. “Some trials even extend to local cancer clinics and doctor’s offices”.

Myth 8: Informed consent exists primarily to protect researchers’ legal interests

Informed consent provides patients with information about their rights as a participant to help them decide whether to participate. “The consent process is actually designed to avoid ‘legalese’ and to make absolutely sure that it is understandable to everybody.”

Myth 9: Once you sign the informed consent form, you’re legally bound to participate

Patients have the right to decline participation at any time. Their doctors will then switch to the standard treatment for their condition. Clinical trials are an important step in discovering new treatments, as well as new ways to detect, diagnose, and reduce the risk of disease. Participating patients receive specialized care from leaders in their field, and trial costs, including patient care and the price of investigational, as well as comparator treatments are covered, resulting in cost savings for the healthcare system. In addition, clinical trials are essential to ensuring the healthcare sustainability as they offer high-quality data to help physicians make informed decisions, including which treatments will be approved and funded.

Myth 10: Patients can’t expect medical personnel to keep them informed

Sharing clinical data helps physicians, patients and healthcare providers make informed treatment decisions. Data sharing can also enable researchers to more easily build on research, with the hope of advancing scientific progress. While sharing is important, protecting the privacy of all individuals participating in clinical trials and ensuring clinical trial data is shared in a responsible manner that safeguards personal information is the most important consideration for companies like ours.

When you join a clinical trial you are required to provide a large amount of your personal health information such as weight, blood pressure, medical history, and sometimes even genetic information. As part of the informed consent process, you will receive information about all of the personal details that will be collected, how it will be used and shared, and how it will be protected. Generally, the clinical information gathered is separated from identifiers specific to the participant (such as individual names) because it’s not necessary for statistical analyses.  When this data is accessed by a researcher, formal data agreements include conditions protecting the confidentiality of individual participant data.

Physicians, medical professionals and research staff are all available at any time to help patients. “We know and appreciate that patients’ willingness to participate is what makes cancer trials possible,”.

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