Why Participate in clinical research?
~Sheila Jones~
“Helping cancer patients in the future has been a key reason for my participation. Cancer is not a journey that I asked for or wanted. However, knowing that my participation in a clinical trial can provide medical answers and medical options for a better journey for future patients has been very important to me. It has given me a sense of purpose.”
Most of today's standard-care medicines are the results of yesterday's clinical trials.
Why would you participate in a clinical trial?
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To provide the viable link between the advancement made in medical science to the resulting improvements made in standard-care medicine.
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To help demonstrate the effectiveness of new approaches to treating health conditions, controlling the side effects of treatment, or preventing future recurrence
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Use an evidence-based process to test and make conclusions of treatment’s safety and effectiveness.
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Clinical trials offer patients a treatment option.
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Taking part in a clinical trial is one way to receive high-quality care from specialists. Our trained specialists, in addition to our physician’s office, carefully and continually monitor clinical trial participants.
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In clinical trials, participants receive the best available current treatments or a new approach that testing has shown may work better than the standard method.
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Taking park in a clinical trial means, individuals are among the first to receive that latest drugs, procedures, and treatments or prevention approaches before they are publicly available.
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faq
Questions to Ask About Clinical Trials
Are cancer clinical trials for people who have no other options?
Trials are often another option that offers a treatment plan that may better address the patient’s needs and continue their quality of life.
Am I eligible for clinical trials?
Every clinical trial has a protocol that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. Each study includes guidelines for who can and cannot participate. These guidelines are called “eligibility criteria”. Eligibility criteria may include age, sex, medical history, and current health status. Your doctor will make sure you are eligible for the study before you begin.
Will I receive inferior treatment?
Clinical trials often are an option for different and possibly better or more effective treatment.
Am I a human guinea pig?
Institutional Review Boards (IRB) comprised of local physicians, nurses, ethics and legal experts, and community leaders must approve all clinical trials and the informed consent documents before trials are approved for people to participate in. These boards have the responsibility to assure that there are no unreasonable risks, compared to the benefits to the human subject. Most clinical trials testing new drug treatments have already been tested in labs in animals and humans.
Do trials always include a placebo or “sugar” pill?
No. Placebos are used only when there is a no standard-care treatment already available. Placebos are rarely used in cancer clinical trials. They are never used in the place of standard-care treatments already given. Any clinical trial that involves a test group that will receive no treatment must inform participants in advance that the trial has a placebo arm.
Can I leave a clinical trial?
Yes, you may leave at any time. Talk to your physician to learn how to do this safely.
Why Participate in clinical research?
~Ed Brandon~
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“It saved my life – I am now in remission and, thanks to the study, feeling great. I can make it through my day without being exceptionally tired. I sleep better, I have my energy level back, and most importantly, I’m back to being able to participate in family events.”
Patient Resources
What is a Clinical Trial?
A Cancer Clinical Trial is an important research study that aims to improve the safety and effectiveness of a step-based treatment. It is also:
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​A research study conducted with actual people.
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A controlled and monitored study in which new drug treatments or new approaches for diagnosing, controlling, or preventing cancers are compared to what is currently available.
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A study designed to answer key scientific questions that will advance medical knowledge.
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Always a voluntary choice for participation.
The Four Types of Cancer Clinical Trials are:
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Treatment Trials: to find superior drugs or test for more effective approaches in using surgery or radiation for treating people who already have cancer.
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Prevention Trials: to test new approaches, such as certain medication, vitamins, minerals, or food supplements, which may lower a person’s risk of a certain type of cancer. These trials are for reducing the risk of developing cancer in healthy people who do not have cancer or preventing the return of cancer in those who have already had cancer.
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Diagnostic/Screening Trials: to compare new techniques for finding cancer, especially early-stage cancers.
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Supportive Care/Cancer Control (also Quality of Life) Trials: to test new ways to improve comfort and quality of life for people with cancer. Some of these trials may also be referred to as “symptom control” trials which address the side effects that often accompany chemotherapy.
The Important Parts of a Clinical Trial are:
Protocol…
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Provides the blueprint for how the trial is conducted.
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Defines the trial’s action plan.
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Explains the purpose of the clinical trial.
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States the research questions the trial is designed to answer.
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Defines who is and who is not eligible to participate.
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Outlines what will be done in the trial. For example, how many of a drug will be given, how often it must be taken, and what medical tests will be required to check on the progress of the study.
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Eligibility Criteria…
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Defines the inclusion and exclusion factors to protect patient safety.
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Ensures that the new treatment or approach is being tested on similar groups of people.
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Ensures key similarities among participants, i.e., the same type of stage of cancer.
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An Informed Consent…
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Is an ongoing process; the participant should receive any new information about the treatment as it is learned.
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Explains key facts of the clinical trial – what will be done in the trial, what type of therapy will be conducted, i.e., radiation, chemotherapy, variation of drug dosages, and how long the intervention will last.
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States the potential benefits and potential risks/possible side effects of the clinical trial.
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Explains what kinds of tests will be conducted (X-rays, blood tests) during the trial to monitor study response.
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Must be signed by each participant. Individuals can freely decide to take part in a trial.
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Why Are Participants Randomized?
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Participant’s randomization is needed to provide non-biased information for the clinical trial. The randomization process provides random selection of participants (similar to flipping a coin). A clinical trial can have two or more treatment assignments (also referred to as “arms”) that are being examined. For example, a drug study may compare the dosage of “Arm A” to “Arm B” and to “Arm C”.
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How are Clinical Trials Conducted?
Clinical trials are conducted in phases. The answers received from Phase I determine whether the treatment will progress to Phase II and then to Phase III. Each thoroughly tested phase serves a specific purpose.
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Phase I: This first point of testing is primarily concerned with safety (How toxic is the treatment?) and the best way to deliver the new treatment.
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Phase II: This level test effectiveness of a treatment for specific tumor types. It is designed to determine whether the agent has an anticancer effect and if it will reduce the tumor size or alleviate symptoms.
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Phase III: For treatment trials, this phase compares the new therapy with the best available treatment currently known. Cancer prevention trials compare the outcome of one agent to another, or compare the results of taking a drug versus taking no drug.
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Control Group vs. Intervention Group
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Studies may use a “Control Group” to compare with an “Intervention Group”. The Control Group receives the best standard treatment or care available. The Intervention Group receives the new drug or therapy approach being tested by the study.
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"Blinding" in Clinical Research
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Blinding keeps one or more parties involved in conducting the trial unaware of the treatment assignment. In a “single-blinded clinical trial, the participant is unaware of which treatment she/he is receiving. In a “double-blinding” trial, neither the physician nor the study participant knows which treatment she/he is receiving. Double-blinded trials are valuable for eliminating the bias. In special situations, if a doctor needs to find out which study drug the participating patient is on, it is possible through the study sponsor’s office.
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