Clinical Trials

Clinical trials are not something that too many people think about until they are diagnosed with a serious illness such as cancer, and yet, cancer breakthroughs would not be possible without clinical trials – where doctors actually test new drugs and procedures on patients. At any given time, there may be hundreds of cancer clinical trials in progress, all looking to improve the care and outcome for cancer patients. Choosing to participate in a clinical trial is a very personal decision, and many factors should be considered – what are the risks/rewards? What do I hope to achieve by participating? Will I be a guinea pig? It’s important to do your own research about the trials you may be considering and that you talk to your doctor before you choose. The following provides a summary about clinical trials and how to find active trials. For more detailed information about participating in a trial and what questions to ask before you join a trial, go to www.cancer.org and www.cancer.gov.

What is a Clinical Trial?

From the earliest history of medicine, doctors have tested new treatments and procedures to see if they work better than existing therapies. Until fairly recently, these “clinical trials” were basically done on a one on one basis with a single doctor and the patients in his practice. However, with the advent of modern medicine and newer drugs, it makes more sense to gather groups of people to test these drugs for a more efficient comparison, so clinical trials have broadened in both scope and territory. Clinical trials are at the end of a long process to bring a new drug to patients:

New cancer drugs and/or procedures start in the lab with a researcher’s new idea. The researcher develops his theory and practices with cells, and then animals to see if his idea offers the possibility of a new treatment. This work can take years – the average drug has been in testing for over six years by the time clinical trials are an option. The work is also all for nothing many times, with only about one in 1,000 drugs actually making it to the clinical trial stage.

Once a drug is available for clinical trial, people are chosen to participate based on their stage and type of cancer, and then their progress is carefully monitored. Because of the length of time that cancer treatments can take, an effective clinical trial may take an average of eight years to complete. Safety is a factor as well; all drugs must meet strict guidelines that are required by the Food and Drug Administration. Patient safety during the trial is also monitored by panels set up to ensure that patients participating in trials receive care and treatment that would benefit them as much as conventional treatment.

It’s important that cancer patients are told about their options regarding clinical trials. The progress of many trials is slowed because there are not enough participants. Although many of the several hundred new drugs that are tested each year do not live up to their promise, some do and without clinical trials, they would never reach the many cancer patients who could benefit.

What are the benefits of clinical trials?

Although there can be significant risks in participating in a clinical trial, the trials help doctors find more effective and safer treatments for patients, and that can bring a certain satisfaction to some cancer patients, knowing that they are possibly changing cancer history. Also keep in mind that there are many reasons for implementing clinical trials – not just for completely new drugs. Some of the other reasons may include:

  • Some trials look at new types of treatment – surgical techniques, radiation therapy, etc.
  • Trials may be pursuing different methods of diagnosis or early detection, and not involve drugs at all
  • Some trials are not looking at new drugs; they are looking at new uses for, or different combinations of, existing drugs that may show promise in other cancers.

It’s also important to know that cancer clinical trials rarely use placebos, or “fake” drugs. Each participant in a clinical trial that tests the effectiveness of a new drug will get at least the current standard treatment during the trial.

What is involved in participating in a clinical trial?

Before a patient is enrolled in a trial he or she must understand all of its potential risks and benefits. Cancer patients may enroll in trials investigating new types of chemotherapy, surgery, radiation therapy or other types of treatment under development. Like any cancer treatment, treatment given during a clinical trial can have side effects and risks. Patients are asked to sign informed consent forms before receiving their first treatment and are monitored carefully during the length of the trial. Patients may see the doctor more often and have more tests than they would if they received an already accepted form of treatment.

Trials are often specific to one type of cancer, such as lung cancer or prostate cancer. Information learned can sometimes be applied to other types of cancer, broadening the use of the results.

Phases of Clinical Trials

Cancer clinical trials are divided into three phases, each trying to find an answer to a specific question about the new treatment. By knowing the phase of the trial you may be interested in, you might be able to understand a little more about what the researcher is looking for.

  • Phase I trials are the first ones that use people to study the new drug or procedure. They usually involve a small number of patients, and many times the participants are those who have no other treatment options remaining. The objective of phase I trials is to find the highest dose that can be safely given to the patient without significant side effects, and the best way to administer the drug. Although Phase I trials have the highest potential risks and the lowest potential rewards of any of the phases, patients do sometimes benefit from the treatment and need to weigh their personal risks and rewards.
  • Phase II trials attempt to answer the question – does it work? More patients are able to participate in these trials, and may be separated into groups – one receiving the current standard treatment and the other receiving the new treatment. In Phase II trials, researchers are looking for the tumors to shrink or not increase in size, or an increase in time before a cancer returns or a higher quality of life for the patient. If enough patients benefit in Phase II trials, the treatment moves to Phase III trials.
  • Phase III trials ask the question – is it better than what we have now? Using a much larger group of patients, most Phase III trials split patients into 2 groups and compare the results from the experimental treatment to the current standard treatment. If the new treatment is better than existing therapies, the new drug is submitted for FDA approval, which takes several months, and then the drug is available to the general public for treatment.

How do I find clinical trials?

Clinical trials were formerly available only in larger cities or cities with significant medical centers. However, many trials now are available to patients all over the country. To help find trials and choose one that may be right, many patients look at clinical trial matching services, some of which are free, others not. The following are some of the available resources:

  • The American Cancer Society collaborates with the Coalition of Cancer Cooperative Groups in providing clinical trial information on its website, www.cancer.org, or at the toll free number 1-800-303-5691. The Society’s trial database is very comprehensive and helps patients find trials that are best suited to their needs.
  • The National Cancer Institute provides a list of all current government trials, as well as some private studies, on their website, www.cancer.gov/clinicaltrials or at their toll free number 1-800-4-CANCER.
  • EmergingMed offers a free, confidential matching service to patients looking for clinical trials at www.emergingmed.com.
  • CenterWatch maintains a list of industry-sponsored and government-funded clinical trials for cancer and other diseases.
  • Most major cancer centers, such as the University of Texas M D Anderson Cancer Center in Houston, and even local hospitals and doctors’ offices usually offer clinical trials information and availability on their websites.
  • Some pharmaceutical or biotechnology firms may list the studies they are sponsoring on their Web sites or offer toll-free numbers to call. They may also offer matching systems for the studies they sponsor. These sites are helpful if the patient has followed the research on a particular experimental treatment and knows the company developing it.