|What Are Clinical Trials?
A clinical trial is a research study which involves studying human responses to a particular situation, treatment or drug. They are usually only carried out after extensive lab research and animal testing has been completed. Most cancer treatments today are the result of past trials. Trials are generally focused on 5 main areas:
To test new treatments, such as new drugs, therapies and better cancer surgery procedures. Also to find better ways to handle cancer surgery recovery.
To uncover better tests for cancer diagnosis.
Lifestyle adjustments, drugs and therapies for cancer prevention. Also investigates causes of cancer.
To test the best way to uncover cancer in the general population.
Quality of Life
Supportive care trials to explore ways of improving palliative care.
If you have cancer you may want to consider joining a trial as a viable treatment option. The National Cancer Institute (NCI) sponsors thousands of trials including those researching female specific cancers such as breast cancer, vulva cancer and vaginal cancer, ovarian epithelial/stromal cancer, ovarian germ cell tumors, cervical cancer and endometrial cancer.
How Do They Work?
In order for a drug or treatment to become standard practice for an illness it must first go through 4 or 5 trial phases. As a participant in a trial, you do not have to take part in all those phases.
To find a safe dose.
To decide how a new treatment should be applied.
To see if there are any side effects which have not shown up in animal testing.
No. of Participants: 15 to 30 people.
As little is known about the effects of the treatment at this stage on humans, phase 1 is riskiest part of any trial. Usually only patients with metastatic cancer (cancer which has spread to other organs in the body) are allowed on this phase.
To find out if the treatment being trialed has an effect on the cancer under review.
To see how the treatment affects the body.
No. of Participants:
Up to 100.
To see if the treatment works better than the current standard treatment.
No. of Participants:
From 100 people to thousands.
To assess the long-term effectiveness and safety of the new treatment. This can take years.
No. of Participants:
Hundreds to thousands of people.
Who Can Join A Trial?
Who is eligible to join a trial will depend on what question(s) the researchers are trying to answer. Each trial will have a protocol stating who can or cannot join. Usually that protocol will state either or some of the following:
• What type or stage of cancer the person should have.
• What age category the person should fall into.
• Which treatment or therapy the person should have received (or not) in the past.
The aim of the researchers is to select a group of people who are as alike as possible. This is to ensure that the results will be attributed to the treatment under study, rather than any other factors. All those selected will undergo rigorous health checks to ensure that the experimental therapy will not worsen their cancer symptoms, but this cannot always be guaranteed.
What Does Randomization Mean?
Once patients have been selected for a trial, any credible institute will randomly assign those patients to either (1) the group who receives the experimental therapy or (2) the group receiving the placebo or standard treatment. Until the study is completed, neither the patient, researcher nor doctor knows who received what (a computer program assigns random numbers to patients). If there is no alternative standard treatment then group 1 will be compared to patients who receive no treatment at all. This process of selection is known as randomization and it ensures that no human bias can influence the results. Typically it is applied to phase 3 onwards (occasionally phase 2). A trial which operates this method is known a randomized clinical trial. If you join such a trial you have a 50/50 chance of receiving the experimental treatment. Your doctor will have no influence in the matter.
Will I Get A Placebo?
A placebo is a pill, liquid or powder which is designed to look like the drug being tested, but it does not contain the active ingredients. Placebos are very rarely used in cancer trials as most patients cannot afford to risk receiving no treatment at all. Most cancer studies will compare the experimental treatment with the currently accepted treatment. Although historically most cancer patients have not joined trials, for many it can be an excellent way to not only treat their own condition, but to help future generations who come after them.
How Do I Decide To Join A Trial Or Not?
There is a standardized process called Informed Consent, which helps patients to decide whether or not they wish to join a clinical trial. With the help of the nurses and doctors attached to the trial the patient will learn about the aim of the study, the potential benefits and risks involved. They also have the right to discuss the study with the principal investigator if they have any concerns. If you agree to join a trial you will be given an informed consent form to read and sign.If you are thinking about joining a trial, here are some questions you may want to ask the research team:
• Why are you doing the trial?
• Why do you believe the treatment you are testing may be better than the current standard one?
• How long will I be in the study?
• What tests or treatments will I need to undergo?
• What are the possible side effects/benefits?
• Will my daily life be affected in any way?
• How will I or the doctors know if the treatment is working?
• Will I have to pay for any tests or treatments?
• Will I have to travel far for treatment and if so, how often?
What If I Want To Leave A Trial?
If you agree to take part in a study, you have the right to leave at any time, even if you sign a consent form. Your doctor will then discuss other treatment options with you, including alternative therapies for cancer.
Useful Article: Cancer fighting foods
Where Do Trials Take Place?
Traditionally phase 1 trials are carried out in major cancer centers with patients who are already hospitalized. If a study progresses to phase 3 then research is done in smaller cancer centers, hospitals or in the community through the Community Clinical Oncology Program (CCOP) of the National Cancer Institute. The CCOP runs thousands of studies at any one time throughout the United States.
How Much Will It Cost Me?
The costs involved in any study can vary widely, but it is common for patients in phases 1 and 2 to have all their treatments covered without charge. All subsequent phases may provide the experimental treatment free of charge but any routine procedures outside of this will need to be covered by the patient's insurance company. It is important to check with both the research institute and your insurance company before starting a trial, who is prepared to cover what. Many insurance companies balk at paying any 'experimental' medical costs. Typically costs work out as follows:
This is the care that cancer patients receive, whether or not they are in a trial. This includes routine doctor visits, X-rays, scans and lab tests. These costs are often paid by the health insurance company. If you have Medicare, they will pay for these routine costs in studies funded by federal agencies such as the National Institutes of Health.
These costs related to expenses incurred directly as a result of the trial, such as doctor/nurse consultancies, drugs, procedures, tests specific to the study and lab time for analyzing those results. These costs are usually covered by the institute sponsoring the study. An insurance company is likely to consider them ‘experimental’.
What Are The Pros And Cons?
As with any treatment option, experimental therapies have possible advantages as well as disadvantages. These include:
Cancer trials always offer the best of patient care. If you are in a randomized study then you may receive the experimental treatment which could offer greater benefits than the market-standard treatment. If you are in the control group, you will at least receive the best standard treatment.
If the experimental treatment does work, you will be one of the first patients to benefit.
You have the opportunity to help cancer research and many generations of women who come after you. Most standard treatments today required people like you in the past to take part in clinical trials to prove their worth.
You have the opportunity to take a more active role in your recovery or the management of your disease.
You are likely to have better access to expert medical care at leading health facilities.
The new treatment may prove not to be as good as the standard care you could have received.
Experimental therapies sometimes have side effects which researchers had not accounted for. Those side effects could be worse than those associated with standard therapies.
Not all treatments (including standard ones) work for everyone. So while other patients on the study might see improvement, there is always the risk you will not. This can be particularly disappointing.
Taking part in any experimental treatment may cause problems with your health insurance company. This is why it is important to clarify before you begin with both your insurance company and researchers, who will cover what.
You may be required to spend more time on your treatment than you would otherwise have. This includes extra hospital visits, tests and hospital stays.
How Do I Find A Trial?
National Cancer Institute
The NCI has the most comprehensive list of trials in America which are open for application. Their database has over 8,000 studies covering areas such as cancer treatment, genetics, diagnostic methods, screening, palliative care and cancer prevention. Studies can be located according to location, type of cancer, treatment intervention (such as chemotherapy, colonoscopy, radiation therapy or adjuvant therapy) and drugs (if any) involved. Until 2010 patients could apply directly through the NCI for participation, but due to changes in Federal law this is no longer possible. Instead the patient must contact the research institute directly, but the NCI provides those contact details.
National Cancer Institute
This is another database provided by the U.S. National Institutes of Health. It contains trials that are federally and privately supported in the US and worldwide. It provides details about the studies, who can join, the location and contact details for application. Always discuss any trial with your health care provider.