Medically Reviewed By
Karen Ritter, RN BSN
JUMP TO A TOPIC
What Is a Clinical Trial?
A clinical trial is a test of a new therapy or approach to treatment for a disease such as cancer. Clinical trials are the proving ground for many new types of cancer treatment.
Clinical trials are usually held at cancer centers and top hospitals. When a patient is diagnosed with cancer and meets with their doctor, one of the options presented to them is enrolling in a clinical trial at the hospital or another cancer center.
Clinical trials are usually free for the patient, meaning they don’t have to pay to receive the new treatment. Clinical trials can save patients and their families tens of thousands of dollars.
Who Benefits From Clinical Trials for Cancer?
Clinical trials for cancer usually benefit patients with a late-stage disease the most. For instance, patients with stage 3 or stage 4 cancer often are offered a spot in a clinical trial because surgery is not an option for them and FDA-approved therapies won’t help extend their survival by much.
There are clinical trials for stage 1 and stage 2 patients. In fact, many phase 1 and phase 2 trials enroll these patients because the doctors and researchers running the clinical study want patients with the best chances of survival. When clinical trials reach phase 3, the selective enrollment usually stops.
Basic Information About Clinical Trials for Mesothelioma
Mesothelioma clinical trials are medical studies used to experiment with new treatment approaches for this disease. Clinical trials give hope, especially to people diagnosed with mesothelioma. Doctors and researchers use mesothelioma clinical trials to investigate, and hopefully prove, the effectiveness and safety of treatment methods.
The end goal of these studies is to receive approval from the United States Food and Drug Administration (FDA) to make a specific treatment a standard of care for this cancer. These treatment investigations can include:
- Specific drugs
- Combinations of different therapies
- Quality-of-life and mental health evaluations
- Support methods
- Diagnostic tests to better identify the presence of mesothelioma
One of the benefits of mesothelioma specialists and cancer centers is their ability to connect patients with clinical trials. Most, if not all, mesothelioma treatments and diagnostic procedures in use today have gone through clinical testing to ensure quality and safety.
The testing process, from concept to FDA approval, is lengthy. Medical breakthroughs for mesothelioma may exist, but they are not yet formally approved.
Benefits of Mesothelioma Clinical Trials
If you have mesothelioma, then enrolling in a clinical trial can provide you an opportunity to receive new experimental treatments. Most participants in mesothelioma clinical trials have already received one or more of the approved standard mesothelioma treatment options and are now seeking additional therapeutic options. Strict regulations and procedures control these trials to ensure patient safety.
New treatments come in the form of radiation, chemotherapy, experimental drugs such as immunotherapy or oncolytic virus therapy, or multimodal therapy that utilizes surgery. One, or some combination, of these treatments could be the cure for mesothelioma.
Health insurance often covers the medical care that’s part of clinical trials. Speaking with a specialist who is familiar with the trial’s sponsor or host company may help determine whether your insurance is accepted.
You can learn more about clinical trials in our free Mesothelioma Guide.
FREE MESOTHELIOMA GUIDE
Mesothelioma Packet Includes:
- 200+ Pages about your diagnosis
- 3 Books to improve your prognosis
- Wristbands to show your support
Clinical Trial Process
There are at least three phases of testing that a treatment must go through before the FDA considers approving it. A fourth phase may be needed for further testing and research.
Phase 1 is a test on a small group of people to determine:
- Whether the drug is safe to use
- How much of the drug the body can tolerate
- Potential side effects
- The most effective dosage
- How to administer the treatment (pill, liquid, intravenous or suppository)
According to the FDA, phase 1 trials typically last several months and include a smaller number of participants than the other phases. This phase is integral for designing tests in future phases of the clinical trial.
Phase 2 aims to determine the effectiveness of a treatment option. It ascertains how that treatment affects the area where the mesothelioma exists. The researchers examine whether there is disease response — either the cancer has regressed or stagnated in growth — and whether the same results can be reproduced in different patients.
According to the FDA, phase 2 trials can take up to two years to complete.
Phase 3 is often the final phase of clinical testing, and the results from this phase could lead to the FDA approving the treatment. Phase 3 tests whether the experimental treatment has better benefits than standard therapies. The benefits must include both disease response and safety.
Participants are often randomized into separate groups. One group will receive the experimental treatment, while the rest will act as a control group. Researchers use this setup to compare the effects of the treatment to what patients currently have available to them.
According to the FDA, phase 3 trials can take up to four years to complete. Few mesothelioma studies reach phase 3 status.
After the FDA approves a treatment, the agency may continue clinical testing. This step is called Post-Market Safety Monitoring, and it’s used to ensure that treatments are safe for widespread use. There is no timeframe for completing phase 4 trials.
Clinical Trial Success Story
Kendra Ferreira was diagnosed with peritoneal mesothelioma in 2001. Afterward, she began looking for additional treatment options. She faced a lack of available treatments for patients like her. Kendra found a mesothelioma specialist and participated in a clinical trial surgery, followed by chemotherapy. Nearly 20 years later, Kendra is a mesothelioma survivor.
“I was fortunate to be accepted into a clinical trial and I believe it saved my life,” she said.
How to Enroll in a Clinical Trial for Mesothelioma
Joining a mesothelioma clinical trial is entirely up to the patient and requires informed consent. Patients receive complete information regarding the clinical trial from their doctor. They’ll then sign a waiver agreeing to participate in the study. If at any time the patient would like to leave the trial, they are free to do so.
Each clinical trial is unique, with its own set of rules and standards that determine whether a patient is included (accepted) or excluded (denied). Patients are individually evaluated using test-related specifications, including:
- Age: Certain trials may test a treatment on a specific age group (example: 45-55). This disqualifies anyone older or younger than the specified age range.
- Gender: Certain studies may only apply to women (example: dual treatments on ovarian cancer and peritoneal mesothelioma). Other trials may use male hormones that would exclude women.
- Current health: The current or past health of a patient may determine whether certain trials accept them. Some trials won’t accept patients with particular medical histories.
- Mesothelioma type and stage: Certain trials focus on a specific mesothelioma type or stage (example: stage 2 pleural mesothelioma).
- Past treatment: Some studies exclude patients — or look to enroll patients — who have already undergone a specific treatment (example: surgery, chemotherapy or radiation). Studies may exclude patients who have already participated in a similar study (example: a previous immunotherapy study).
- Candidacy for future surgery: Many studies may exclude or enroll patients based on whether they are candidates for surgery.
Patients are accepted or denied based on these qualifications. There are many ongoing clinical trials for mesothelioma. If a patient is rejected from one trial, they should still apply to others.
Placebo-Controlled Mesothelioma Clinical Trials
Some people hesitate to enroll in clinical trials due to use of control groups and placebo-controlled trials. Understanding your options and how these studies help may alleviate concerns.
The words used to describe clinical trials can also create confusion. Terms such as “randomized,” “double-blind” and “placebo-controlled” refer to how a mesothelioma clinical trial is conducted and measured.
Every placebo-controlled clinical trial abides by the following rules:
Capable of Results – The study must be capable of producing results. Using a control group is the best way to get results.
Avoiding Unnecessary Harm – Mesothelioma patients who choose to participate in placebo-controlled trials are those for whom there are no other treatments with significant curative potential.
Potential Benefit – Offering a treatment option that may benefit the patient is the goal of all clinical trials. Placebo-controlled trials are no different. All trials are backed up by years of research and testing before human trials begin.
What Are Placebo-Controlled Trials?
Half the participants in this trial are given the drug being tested, while the other half are given a “placebo.” The placebo is a pill that looks identical to the actual drug but doesn’t contain any medicine. Those who get the placebo are chosen randomly, making the study “randomized.” A “double-blind” trial means neither the doctors nor the participants know who got a placebo.
Here are some things each patient should know:
- Neither the patient or the doctor is aware of who received the placebo.
- Those who receive a placebo are chosen at random.
- A single trial does not offer individualized treatment.
- If a patient’s condition worsens, they can drop out of the trial.
- All participants receive the same quality of medical care offered by the cancer center.
Why Are Placebo Clinical Trials Used?
Researchers can get faster results by using placebo-controlled studies. Placebos provide a comparison, which helps researchers determine if the experimental drug is effective.
Placebo-controlled trials produce faster results because they use a control group of participants. The control group is used to compare to the group receiving the drug and helps researchers determine if the drug had any discernible effect. Without a control group, researchers don’t know for sure if improvements in survival are caused by the drug being tested.
Given that mesothelioma is so rare, and only a fraction of mesothelioma patients participate in clinical trials, this is makes placebo-controlled trials truly beneficial to developing new treatments for patients.
The main reason mesothelioma patients participate in placebo-controlled trials is because they have exhausted more traditional forms of treatment. These trials are for those who are determined to keep fighting. If you want to keep fighting, get connected with recruiting clinical trials today.
Why Are Placebo-Controlled Clinical Trials Randomized and Double-Blind?
Placebo-controlled trials are randomized and double-blind to prevent bias in the study results. These methods also give each participant a fair chance of receiving the non-placebo drug.
Participants in a clinical trial have the option to drop out of the trial if their condition gets worse. Additionally, experimental drugs are only tested on patients for whom there is no proven effective treatment available. Participants should always be aware of their ability to opt out.
Mesothelioma Research Efforts
Mesothelioma is one of the rarest forms of cancer. Research being done on this disease is heavily supported and funded by grants from the National Cancer Institute (NCI). NCI is a federal agency that mandates how financial resources are allocated to different cancer research projects.
Here are a few organizations invested in mesothelioma research:
- Mesothelioma Applied Research Foundation
- American Cancer Society
- Brigham and Women’s Hospital International Mesothelioma Program
- Baylor St. Luke’s Cancer Center
- Abramson Cancer Center of Penn Medicine
- MD Anderson Cancer Center
- Moffitt Cancer Center
- University of California San Francisco Medical Center
- Pacific Meso Center
These are just a few of the notable organizations invested in mesothelioma research. Other groups are issuing grants or receiving grants for mesothelioma research. The intent is to develop new therapies and better understand how mesothelioma cancer grows.
Safety of Mesothelioma Clinical Trials
The safety of clinical trials is a reasonable concern for anyone with cancer who is offered a spot to join a study. There is always a risk with new, unapproved therapies. Since mesothelioma is a rare and deadly cancer with just a few approved therapies, there are many innovative approaches and ideas tested in clinical trials. Many of them are outside-the-box attempts to improve life expectancy for patients.
Participants should understand the risks of joining a mesothelioma clinical trial but also know that doctors and researchers make patient safety their top priority during studies.
Participants in any clinical trial are closely monitored by some of the best specialists in the country. If a patient’s condition worsens, the doctor will discuss the circumstances. Participants always have the option to drop out of the clinical trial.
Deciding whether to participate in a mesothelioma clinical trial comes down to weighing your options. If you already had treatment, and this is the only potential maintenance treatment for you, then it is usually worth a shot.
Contact one of our patient advocates to learn about clinical trials and expand your treatment options.
Sources & Author
- What Are the Phases of Clinical Trials? American Cancer Society. Retrieved from:
https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html. Accessed: 06/02/2020.
- Step 3: Clinical Research. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Accessed: 06/02/2020.