In 2015, an estimated 15 million+ people in the United States were living with cancer. Chances are that at least 38 percent of people will receive a cancer diagnosis at least once in their lifetimes.
These kinds of statistics explain the push to fund clinical cancer research in an effort to bring a halt to the spread of this all-too-prevalent disease.
The 411 on Clinical Cancer Research
If you want to help researchers, physicians, and scientists tackle this formidable task, there are 10 things you should understand about clinical cancer research.
1. The Definition of Clinical Trial
It’s important to define a clinical trial in order to outline the differences between this and other types of research.
The World Health Organization (WHO) defines a clinical trial as, “. . . any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Of course, this definition requires that we also define what “health-related interventions” mean. Health-related interventions refers to the type of therapy that patients in the study receive.
These can include, but are not limited to:
- Surgical procedures
- Cells and biological materials
- Preventative care
- Care process changes
- Radiological treatments
- Behavioral treatments
- Psychological treatments
2. The Purpose of Clinical Trials
The purpose of a clinical cancer research trial is not as simple as “finding a cure for cancer.”
A clinical trial is part of a complex set of steps, tests, and observations that can help determine how a new therapy will affect the people receiving it.
Believe it or not, until the 20th century, there weren’t a lot of effective cancer treatment options available. Instead, doctors used a combination of education and hands-on experience to determine what worked best for their patients.
As more and more cancer treatments reached the market, doctors found they needed a good way to compare therapies for specific cancer types.
Clinical research trials developed as a way for researchers to compare the effectiveness of therapies within a large, specific group of people. For example, men suffering with prostate cancer.
This format allows doctors to see the therapy at work among an entire population rather than just a few patients, giving them a better perspective on the pros and cons of each therapy.
3. The Makeup of Clinical Trials
A clinical trial is not an end unto itself. It is simply part of a long, well-documented, well-researched cancer research process.
The trials are conducted in phases for the safety of participants.
For example, a promising new cancer drug never goes straight to clinical cancer research trials — it first has to pass through a string of preclinical trials and then move to animal studies.
Animal studies are an important first step to address therapy safety and efficacy, but as animals and humans don’t always respond similarly, a phase of human trials is required.
The first human trials are called Phase I trials. There are usually a small (50 or less) number of participants in this trial, which is closely monitored.
Normally in a Phase I trial, researchers are examining the maximum safe dosage and noting any side effects of the therapy.
This is the riskiest trial for human participants, so those selected are usually individuals who have late-stage cancer or have run out of treatment options.
After a successful Phase I trial, researchers will conduct a Phase II trial, using 100 or more participants. At this stage, researchers are hoping the therapy shows beneficial effects for a large number of participants.
If the drug makes it to Phase III, it undergoes the longest and most rigorous of research trials. Phase III is normally undertaken in a double-blind, randomized way using large numbers of participants over a long period of time.
“Randomized” refers to the fact that study participants receive either the traditional treatment method or the new therapy in a completely randomized way. “Double-blind” means that neither the participant nor the researchers know if the participant is receiving the new therapy or the standard care treatment.
Conducting a study in this manner removes the possibility that the researchers or participants can unknowingly influence study outcomes.
In this way, the randomized, double-blind study is the gold standard for research as it tends to yield a much more reliable result.
In Phase III, researchers are comparing the new therapy to traditionally accepted therapies and looking for increase in benefits or effectiveness as well as potential side effects.
Phase III trials are normally conducted in several locations simultaneously to get data on the largest number and variety of people possible.
After successful Phase III trials, new therapies can be released to the public, normally in still limited amounts.
4. Types of Clinical Trials
Besides treatment trials, there are three other trial types that cancer patients may be interested in. They are:
- Screening trials that aim at finding new ways to diagnose cancers at an early and more treatable stage
- Prevention trials that look at ways to lower cancer risk through various lifestyle changes. They are conducted among the population that has never experienced cancer
- Quality-of-life trials that seek methods to improve life quality for cancer patients
All of these trial types play an important role in the development of new, more effective therapies to target all aspects of the cancer disease process.
5. The Benefits to Participants of Clinical Trials
There are many benefits to participants of clinical cancer research trials, particularly because many types of cancer do not respond well to currently available treatments.
Also, clinical trials can prove beneficial for people who have advanced-stage cancers and have run out of treatment options.
For studies that focus on cancer prevention, the benefits to participants are likely to include increased overall health as these studies focus on nutrition and lifestyle changes.
Patients who participate in quality-of-life trials benefit through access to state-of-the-art ameliorative care. This care can be drug-based or even psychological, behavioral, educational, and nutritional.
6. Eligibility for Clinical Trials
Eligibility requirements vary according to the needs of each clinical cancer research trial.
Some require certain demographics such as gender, age, and ethnicity, while others focus on the cancer type or stage.
7. Drawbacks to Clinical Trials
The risks of participating in a clinical cancer research trial is related to the newness of the therapy.
With untested drugs, there is always the possibility of long-term, potentially harmful side effects developing over time.
8. Placebos in Clinical Trials
Some trials use placebos to decide whether a better result is produced by adding something to the current treatment protocol. A placebo is a pill or substance that is completely inactive, such as a “sugar” pill that is given to participants, who believe they are receiving new medication.
Placebos are normally given along with the current standard of care. Rarely do clinical cancer trials include a “no treatment” group.
9. Locations of Clinical Trials
The National Cancer Institute has a page that can help you find a research trial near you, and sometimes trial information is disseminated to doctor’s offices, through medical journals, and even through advertising in magazines and newspapers.
Fortunately, clinical cancer research trials are so widespread that you can find them at large medical centers, community centers, and even doctor’s offices.
10. Funding for Clinical Trials
While research costs are normally covered by the entity conducting the clinical trial, other costs to participants may or may not be covered.
If the study doesn’t cover all the costs, your health insurance company may provide some benefits to help with the trial.
Contact your insurer before agreeing to participate in any clinical trial to ensure you won’t have any out-of-pocket costs.
Putting It All Together
If you have cancer and are interested in furthering cancer research through participating in a clinical cancer research trial, you will be making a huge contribution to the health and well-being of cancer patients throughout the world.
Even if you are cancer-free, you can make a difference by participating in a study that focuses on preventative measures.
If you’re thinking of participating in a clinical trial, discuss options with your doctor in advance of applying to be included in the study.
Your doctor will be able to provide insight on whether or not the study is a good fit for you and can also help you determine if your insurance provider will cover some or all of the costs of participation.