UNDERSTANDING CLINICAL TRIALS

Learning that you have cancer can be an overwhelming experience for both you and your loved ones. Even while you are processing the information, you must make decisions about next steps in how you’ll treat the disease. There are many options for your therapy. Participating in a clinical trial is one of them.

The information below provides the very basics of clinical trials. Additional information can be gathered from your Patient Navigator, care team and hospital.

What Is A Clinical Trial?

A clinical trial is a research study that involves people. Clinical trials are usually the last step in a very long process to approve a treatment for general use. The people who conduct clinical trials are typically called “investigators,” and they can focus on all stages of cancer. Questions being asked in clinical trials are focused on finding new ways to:

  • Treat cancer
  • Find and diagnose cancer
  • Prevent cancer
  • Manage symptoms of cancer and/or side effects from the treatment of cancer

Be they drugs or vaccines, ways to do surgery or give radiation therapy, or combinations of treatments, clinical trials test many types of treatments. All treatments that are considered standard of care were once studied in a clinical trial!

What Are the Different Phases of a Clinical Trial?

Within the world of clinical trials, there are 3 or 4 different phases that each treatment must pass in order to eventually be approved for general use. During each phase, different qualities of the treatment are studied. The number of people that are involved in a clinical trial also increases as it passes through each phase. Phase 1 Trials can have 15-30 people, Phase 2 can have up to 100 people, and sometimes Phase 3 can have several thousand participants.

Phase 1

Phase 1 clinical trials can sometimes be called “safety trials” as investigators are looking to see if the treatment is safe without comparing it to the standard of care. Phase 1 Trials can be used to determine:

  • What is the safest dose of this treatment?
  • What is the safest method to administer the treatment (by mouth, by vein, by shot)?
  • How long does the treatment/drug stay in the human body?

Phase 2

Phase 2 clinical trials start to look at how effective the treatment is at curing a disease and continue to make sure that the treatment is safe. Phase 2 Trials can be used to determine:

  • Is the treatment effective in curing the disease?
  • How does this treatment affect the human body (side effects, benefits)?
  • Is this treatment still safe in a larger group of people?

Phase 3

Phase 3 clinical trials are used to compare the new treatment to the standard of care. Phase 3 Trials can be used to determine:

  • How safe is this treatment compared to the standard of care (are there more or less side effects)?
  • How effective is this treatment compared to the standard of care (which one is better)?

To keep up to date with clinical trials and to find clinical trials that are right for you, register for ACCESS, a free portal to the world of cancer research.

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Who conducts Clinical Trials?

There is an array of people who help conduct a clinical trial. There is a principal investigator, often a medical doctor, who is responsible for leading the trial. There is also a research team, composed of doctors, nurses, social workers, and other healthcare professionals.

Clinical trials may be sponsored – or funded – by a variety of entities, including drug companies, academic medical centers, Federal agencies like the National Institute of Health, or private groups. Even doctors, health care providers, or individuals can sponsor a clinical trial.

Where are Clinical Trials conducted?

Hospitals, universities, clinics, doctors’ offices – there are many places that a clinical trial may be conducted depending on who is sponsoring the study. The nearest location to a participant might require travel, which is something important to consider.

How Long Does a Clinical Trial Last?

Depending on the clinical trial, a study will vary in length. This is an important detail to take into consideration when researching trials.

Who can take part in clinical trials?

Each trial is trying to answer questions about a treatment, so criteria for participants is set by the clinical trial protocol. Common criteria include:

  • Having a certain type or stage of cancer
  • Having received a certain kind of treatment in the past
  • Being in a certain age group

It’s important that people participating in a trial are as alike as possible. This ensures doctors are looking at similar results from similar people. In some cases, other health issues may disqualify a person from participating because doing so would increase risk of adverse effects. Medical tests are an important initial step for someone thinking about joining a clinical trial.

What Guidelines Do Clinical Trials Follow?

A Principal Investigator has direct responsibility for conducting a clinical trial. S/He prepares a plan for the study, called a protocol, which is like a recipe for everyone involved to follow.

This protocol explains what the trial will do, how the trial will be implemented, and why each part of the trial is necessary. Information is very clear about:

  • The reason for the trial
  • Who is qualified to join the trial
  • How many people are required for the trial
  • Any drugs to be taken, the dose, and dosage schedule
  • What medical tests will be conducted and when
  • What information will be gathered and reported

How is the patient protected?

The federal government enforces rules to ensure that clinical trials are run in an ethical and safe manner. As a patient participating in a clinical trial, you have rights and your safety is ensured in several ways.

Informed Consent. This is an important process that educates you about a clinical trial’s purpose, risks, and benefits, and it is required you receive this information from the research team of doctors and nurses before you decide whether to participate. At this time, you are also informed of your right to 1) make a decision about participating, and 2) leave the trial at any time.

After discussing all aspects of a trial with you in a way that you understand fully and answering any questions you may have, you will receive an Informed Consent Form. It is a written document outlining all of the information you have learned, as well as details about how your health information is protected. If you are in complete agreement with everything you read, you will sign the form. But remember, even if sign the Informed Consent Form, you always have the right to leave the trial at any time.

Scientific Review Panels (SRPs). Every trial is reviewed by a panel of experts before it can commence and accept participants. Government-funded trials are required to pass this review; many other trials that are sponsored by drug companies or educational institutions ask for a panel’s advice on trial protocol and overall merit of the research planned.

Institutional Review Boards (IRBs). This board is made up of a mix of medical specialists and community members, all from diverse backgrounds. Prior to the trial accepting patients, risks are compared to benefits. Once the trial is underway, the IRB watches closely to ensure the protocol is being followed and patients are being treated safely and ethically.

Data and Safety Monitoring Boards (DSMBs). Phase 3 trials, as well as some Phase 1 and 2 trials, require a DSMBs oversight to ensure safety. This board is made up of statisticians, physicians and other experts who are tasked with ensuring risks of the trial are being reduced as much as possible, checking that trial data is sound and thorough, and stopping a trial if safety is an issue or as soon as the trial’s objectives have been met.

What do I need to think about before I decide to participate in a clinical trial?

Your loved ones and medical team are people on whom you can rely for clarity and reassurance, but choosing to join a clinical trial is a decision only YOU can make. In addition to the fine details of a trial’s protocol, there are pros and cons and questions to consider with your doctor and people close to you.

The Potential Pros. To begin, consider the very active role you are playing in weighing options about how to treat your diagnosis. You are not only helping yourself by participating in a trial, but you are also helping others as the medical community seeks to improve cancer treatment.

As well, clinical trials offer high-quality cancer care. Even in a randomized study, everyone participating receives the best known standard treatment. This may be as good as, or better than, the new approach being tested. If the treatment being tested in your trial is proven to work and you are receiving it, you may be among the first to benefit!

The Potential Cons. New treatments that are being studied are not always better than, or even as good as, the best known standard of care. In some randomized trials, you may not receive the new treatment, and if you do, there may be side effects that doctors do not anticipate or that are worse than the standard treatment.

Health insurance coverage will vary from plan to plan, and some patient care costs may not be included in your benefits. It is critical you check with your insurance provider and the billing staff of the hospital, doctor’s office, or health clinic you are visiting

Can you give me a list of questions to ask so that I have the information I need to decide if I want to participate in a clinical trial?

If you are thinking about taking part in a clinical trial, there are many questions to ask. An ACCESS Patient Navigator is available to walk you through each step of the process. Here are the main topics you’ll consider together:

About the Trial.

  • Why is the trial being done?
  • Why do the doctors who designed the trial believe that the treatment being studied may be better than the standard treatment already in place? Why may it not be better?
  • How long will I be in the trial?
  • What kinds of tests and treatments are involved?
  • What are the possible side effects or risks of the new treatment?
  • What are the possible benefits?
  • How will we know if the treatment is working?

Costs of the Trial.

  • Will I have to pay for any of the treatments or tests?
  • What costs will my health insurance cover?
  • Are there outside organizations who can help me cover any costs of the treatments or tests?

Daily Life While on the Trial.

  • How will the trial affect my daily life?
  • How often will I have to visit a hospital or clinic?
  • Will I have to travel long distances to take part?

Comparing Other Treatments to a Clinical Trial.

  • What are other treatment choices I have, including standard treatments?
  • How does the treatment I would receive in this trial compare with the other treatment choices?

Can I leave a clinical trial after joining?

Yes. Many factors may come into play after starting a trial, and you may decide leaving is better than continuing. Although ideally all study participants remain enrolled until the study’s completion, leaving is allowed at any time.

Can I be compensated for participating in a clinical trial?

Every trial has its own policy regarding volunteer compensation. Some trials may reimburse volunteers for expenses related to their participation or even offer some compensation to volunteers for participating. Some trials that require significant travel or an overnight stay may cover the associated expenses. Details about compensation will be laid out in study documents.

What happens after a clinical trial is over?

As the National Institute of Health clearly explains, after a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.

Ask the research te members if the study results have been or will be published. Published study results are also available by searching for the study’s official name or Protocol ID number.

Don’t wait until you have to make a decision to gather the information you will need to make one.

We have worked with hundreds of people looking for cancer treatment options. From these experiences, we know that the more time someone has to find and consider all of their options, the more confident they can be in the decisions they make.

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