Clinical trials offer groundbreaking research that is still in a testing phase. They can include tests for cancer treatment, prevention, screening, and support.
What is a Clinical Trial?
One of the benefits of specialists and cancer centers is their ability to connect patients with clinical trials. The treatments, medications, and procedures used have gone through clinical testing to ensure quality and safety. The testing process, from concept to FDA approval, is lengthy. Often medical breakthroughs exist but are not yet formally approved.
Reasons to Choose a Clinical Trial
New Treatment Options
All new treatments start out as clinical trials, and this includes each and every one of the common treatments for mesothelioma.
Get Special Treatment
Patients can gain access to innovative new treatment therapies before they become available to the general public.
Mesothelioma survivors swear by them. Kendra Ferreira said, ”I was fortunate to be accepted into a clinical trial and I believe it saved my life.”
Benefits of Clinical Trials
Clinical trials provide patients with an opportunity to receive new experimental treatments before anyone else. Most clinical trial participants have already been involved in standard treatments and are seeking to exhaust all their options. Strict regulations and procedures control these trials to ensure patient safety.
New treatments come in the form of drugs, radiation, chemotherapy, or multimodal therapy. Prevention trials help lower the risk of developing cancer like mesothelioma.
Health insurance covers many clinical trials. Speaking with a specialist who is familiar with the trial’s sponsor or host company may help determine whether insurance is accepted.
Learn more about clinical trials in our free Mesothelioma Guide.
Clinical Trial Process
Before the FDA considers approving any new treatment, there are at least three phases of testing that a treatment must go through. The fourth phase is for further testing and research.
The first phase is a test on a small group of people to determine safety, effective dosage, treatment form (pill, liquid, intravenous, or suppository) and side effects.
The second phase aims to determine the effectiveness of a treatment option. It ascertains how that treatment affects a cancerous region and whether the same results can be reproduced in different patients.
The final phase of clinical testing consists of a large group of patients. Some patients will receive the treatment, while the rest will not. Those without the treatment act as a control group, against which the doctors can measure the effects of the treatment.
Once enough testing has been completed for the FDA to determine the efficacy of the drug, they can approve the medication. After FDA approval, testing continues to ensure effectiveness and safety.
Qualifying for a Clinical Trial
Inclusion in a clinical trial is entirely up to the patient and involves the process of informed consent. Patients receive complete information regarding the clinical trial from their doctor. Then they sign a waiver agreeing to participate in the trial. 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 clinical 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 clinical trials 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 clinical trials accept them. Some trials won’t accept patients with particular medical histories, such as smoking. Other trials may not be as selective about past or present patient health.
- Mesothelioma Type & Stage: Certain trials focus on the effectiveness of treatment on a specific mesothelioma type or stage (example: Stage 2 Pleural Mesothelioma).
Patients are accepted or denied based on these qualifications. There are currently dozens of mesothelioma clinical trials, so if a patient is rejected from one trial they should still apply to others.
A Word About Placebo-Controlled Trials
Some patients may be hesitant to participate in clinical trials. However, understanding the patient’s options and why placebo-controlled trials are used can alleviate any concerns.
The words used to describe clinical trials can also cause some confusion about what is involved. Terms such as “randomized,” “double blind” and “placebo-controlled” refer to how the test is conducted and measured.
- What it means: 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 randomly chosen, making the study “randomized.” “Double-blind” means neither the doctors nor the participants know who got a placebo.
- Why placebos are used: Researchers can get faster results by using placebo-controlled studies. Placebos are important because they provide a comparison by which the researchers can tell if the experimental drug is having any effect.
- Why trials are randomized and double-blind: Placebo-controlled trials are randomized and double-blinded to prevent bias in the study results and to give each participant a fair chance of receiving the non-placebo drug. Those who get the drug are chosen randomly, and neither the patient nor the doctor knows who got placebos or the actual drug.
- If the patient’s condition worsens: Participants in any clinical trial are closely monitored by some of the best specialists in the country. If the patient’s condition worsens, the doctor will discuss the circumstances. Participants always have the option to drop out of a trial if it’s not effective for them.
The choice to participate in a placebo-controlled trial comes down to weighing the patient’s options. If they already had treatment, and this is the only potential maintenance treatment for them, it is usually worth a shot. Get connected to a recruiting clinical trial today and expand your treatment options.