Expert Analysis Highlights:

• Clinical trials serve two purposes: Offering patients the newest treatment options and advancing scientific knowledge for future patients
• Below are some useful questions you should ask when deciding whether or not to participate in a clinical trial
• To find out if there is a trial in the area you need treatment, check out clinicaltrials.gov where all trials are registered
• For more information about clinical trials, click on the following link to patientresource.net

The phrase “Clinical Trials” means one of two things to most people: An opportunity to get the latest and greatest new treatment, or a futile human experiment with no major benefit to them.  The truth is somewhere in between.  The bottom line is that it depends on the trial and its design.

To review, a clinical trial is a program offered by some hospitals which assigns you randomly to receive standard treatment or a new treatment for which the potential benefit is not yet proven.  Some trials have 3 “arms” or treatment paths.  The key to a good research study from a design standpoint is that patients are randomly assigned to a treatment path and then the outcomes are compared.  This is the most scientifically valid way of assessing how good the treatments work.

Here are some useful questions you should ask when deciding whether or not to participate in a clinical trial:

• What is the benefit seen in previous studies of the new treatment being studied in the trial?
• Does the new treatment being studied work by a different mechanism (i.e. a novel treatment) compared to the standard treatment?
• Where did the idea for the clinical trial come from?
• What are the quality of life and survival differences likely if I do not participate in the trial?

For some trials the new treatment may be very promising, while for other trials, the benefit may be marginal or even negligible based on prior studies.

For your protection, all clinical trials are governed by rules which hospitals are ethically and legally obliged to follow.  The rules are: 1) If the benefit of one of the treatment options is clearly apparent during the course of the study, the study must be ended early so that the results can be disseminated and patients do not have to continue a course of treatment which is known to be inferior, 2) You must be informed of every aspect of the design of the study, 3) You can opt out of the trial at any time, and 4) You are entitled to see the results of the study once completed.

Clinical trials serve two purposes: Offering patients the newest treatment options and advancing scientific knowledge for future patients.  Consider it not just a way of getting a new treatment, but also a way of helping inform future patients with a similar cancer.  In general, clinical trials provide hope for patients whose treatment options might otherwise be limited.  Many trials are managed on a multi-institution level, making the trials available on a local level for many patients.

To find out if there is a trial in the area you need treatment, check out clinical trials.gov where all trials are registered.  There you will be able to find out what the treatment arms are, whether the trial is open of closed to new patients, and where to go to see if you’re a candidate.

A diagnosis of cancer can be scary, and understanding a treatment plan confusing. To gain more information, it is sometimes wise to seek a second opinion or advice from another qualified cancer specialist or group of specialists before or even after you begin treatment.

If you are asked to consider alternatives, such as surgery or radiation or chemotherapy or hormone therapy, you might want to hear from each type of oncologist who gives that treatment. It’s all right to look at all your options. A second opinion could save your life or better protect your quality of life.

Options for getting a second opinion:

- Talk to a cancer specialist in another specialty or medical group.

- Ask that your case be presented to a tumor board or tumor conference at your hospital.

- Ask to get a second opinion on your pathology reading, especially if there is any controversy in making a complete diagnosis.

- Seek the advice of a renowned cancer expert usually in a comprehensive cancer center especially if your situation is complicated or uncommon.

For more information, see our companion website: www.patientresource.net. Here’s some of the content from patientresource.net that you may find useful:

Getting a second opinion involves asking another cancer specialist or group of specialists to review your medical records and confirm your doctor’s diagnosis and treatment plan. Other specialists can confirm your pathology report and stage of cancer and might suggest changes or alternatives to the proposed treatment plan. They can also answer any additional questions you may have. There is often collective wisdom gained from the experience and opinions of different oncology specialists who are experts in your type of cancer.

There are lots of reasons for seeking a second opinion. Some doctors may favor one treatment approach, while others might suggest a different combination of treatments. Doctors in each oncology specialty bring different training and perspectives to cancer treatment planning. Another doctor’s opinion may change the diagnosis or reveal a treatment your first doctor was not aware of. You need to hear arguments for all of your treatment options. A second opinion is also a way to make sure your pathology diagnosis and staging are accurate, and that you are aware of clinical trials that you might want to consider.

If you are asked to consider alternatives, such as surgery, radiation, chemotherapy or hormone therapy, you might want to hear from each type of oncologist who provides that treatment. It’s all right to look at all your options; a second opinion could save your life or better protect your quality of life. Most doctors welcome another doctor’s opinion.

Second opinions are also valuable if you live in a small town or rural area where there may not be as many oncology specialists, especially if you have an uncommon type of cancer or might need a highly specialized or complicated type of care. If so, you may want to get an opinion from specialists at a larger medical center or comprehensive cancer center with particular expertise in treating your type of cancer.