Questions to Ask About Clinical Trials

Should You Participate in a Clinical Trial?

doctor thinking of questions to ask about clinical trials
What questions should you ask about clinical trials?. istockphoto.com

What questions should you ask about clinical trials?  What do you need to know so that you can weigh the pros and cons - or risks and benefits as the terms go in medicine?

How Can You Decide if a Clinical Trial for Lung Cancer is Right for You?

With lung cancer, current treatments are finally improving.  Both the treatments for, and survival rate for lung cancer are finally improving, and why?  Because of what we've learned in clinical trials.

 Every treatment we have for lung cancer was once studied in a clinical trial, which means that some people - those in the clinical trials - had the opportunity to use these newer and better treatments before they were available to the public.

How significant is this? Considering that more treatments were approved to treat lung cancer between 2011 and 2015 than had been approved in the 40 year period prior to 2011, this is very significant.  In the past, clinical trials had the reputation as being something you could do to help others down the line that wouldn't likely make a difference for you personally. That's changing.

Is a clinical trial right for you, though? First, it is important to understand what clinical trials are and what they are designed to do. Second, an understanding of the types and phases of clinical trials is important. Some trials are done to see if a treatment is safe.

Others are done to see if the treatment is more effective than current treatments. Finally, a consideration of the risks and benefits of clinical trials and having questions to ask your oncologist can help you decide what is right for you.

Risks vs Benefits of Clinical Trials

When asking questions, keep in mind the pros and cons that go along with each answer.

Possible benefits

  • The study may give you access to treatments that are more effective than standard treatments. This is  https://www.verywell.com/immunotherapy-for-cancer-what-it-is-and-how-it-works-4057117more true than ever with lung cancer, especially with the newer targeted therapies and immunotherapy.
  • You can contribute to medical research that may help someone else with cancer in the future.
  • The study may provide a chance for a cure or prolong life when other methods have failed.
  • The trial may give you access to methods of relieving cancer symptoms not otherwise available.
  • You may be given access to closer follow-ups and have your physical condition evaluated more frequently.
  • If it covers the cost of treatment, the trial could benefit you financially.

Possible risks

  • The study may not directly benefit you in your cancer treatment.
  • The drug or treatment may cause side effects that were unexpected and, in rare cases, death.
  • The study may prevent you from receiving other treatments.
  • Even if the treatment has been effective for others, it may not be for you.
  • The clinical study may expose you to greater amounts of radiation due to follow-up scans than you would like.
  • You may not get the new drug/treatment but a placebo or standard treatment instead. Keep in mind that when standard treatment offers an advantage over a placebo, a placebo group is usually not used.

Questions To Ask About Clinical Trials

  • What type of clinical trial is this? Is it a treatment trial aimed at finding a cure for cancer or prolonging life or is it a supportive trial, one designed to improve quality of life?
  • Why is the trial being done?  
  • What is the "endpoint" of the clinical trial? Your doctor can help you understand exactly what this means and the importance of this question for you.
  • If the clinical trial is a treatment trial, what phase trial is it? Phase 1 clinical trials are designed to evaluate the safety of a new medication, whereas phase 3 clinical trials are done to see if the drug/treatment is more effective than what is currently available.  It's important to understand, however, that in the past phase I trials had the reputation of not necessarily making a difference for an individual and being "riskier" but these same trials are now offering many the people the opportunity for life-saving medications which would otherwise not be available.
  • What other treatment options are available?
  • Will participating in a clinical trial limit any of these other treatment options?  This question is important to ask from both sides.  Some clinical trials may prevent people from using other treatments in the future, whereas using some approved medications may disqualify people from participation in a particular clinical trials in the future.
  • What will participating in the study mean for me? Will I have to travel?
  • Who will be in charge of my treatment and who should I call if I have any concerns?
  • What has been your experience with this drug/treatment in other patients? How many patients have you studied? Can you tell me what the results of the study have shown so far?
  • How long will the treatment last? If I am responding to the drug/treatment, can I continue it after the study is over?
  • How will the clinical trial affect my insurance coverage? Will I be responsible for any costs? Will I be reimbursed for participating in the study or will my medical costs be covered if I develop a side effect? What are the laws considering clinical trials and medical insurance coverage in your state? 
  • Ask Yourself if you're willing to accept the possible risks involved? Will traveling or extra tests pose a hardship on you emotionally, physically or financially? Are your family and friends supportive of your choice to take part in a clinical trial?

Clinical Trial Participation Bottom Line

Choosing to participate in a clinical trial is a very personal decision.  It's important to honor yourself in what you feel is the best decision, no matter what someone else would do if they were to change positions with you.

One excellent resource for learning about clinical trials is one that is often overlooked: social media.  There is a very active lung cancer community online - with many people who actively share their experience in clinical trials studying new treatments for lung cancer.  If you don't know where to begin, the hashtag #LCSM, standing for lung cancer social media, can help you find others facing similar challenges, whether on one of the private lung cancer communities such as inspire, those through LUNGevity, or through broader social media channels such as twitter.  If you do become involved in a clinical trial, keep in mind that the availability of the internet allows people even in small trials to connect, such as those with ROS1 rearrangements, and connect as a mini community.

Source:

National Cancer Institute. Taking Part in Cancer Treatment Research Studies. Accessed 06/10/16. http://www.cancer.gov/publications/patient-education/cancer-treatment-research-studies

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