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Clinical Trials >  How to Inquire about Clinical Trials

Last update: 05/20/2019

Topics:

Asking your Treating Physician | Contacting an Investigator Directly | Consulting an Independent Expert
Consult Checklist | Questions to Ask | Resources

How to Consider and Inquire about Clinical Trials

A Guide for Patients and Caregivers

Is a clinical trial a good choice for you?

Start by reviewing the following guidelines - an overview to help you to decide if there is a rationale for considering a trial and how to discuss the rationale with your medical doctors. 

7 Reasons to Consider Trials based on our clinical circumstances 
 

Locating clinical trials on your own (optional)?
 

bullet

Proceed with caution.  It's easy to get it wrong. You or a loved one should have
background in how to interpret study results and base your research on the
full reports (not the media).  Researchers who are running the study have a
potential bias so get a second opinion from an independent expert and your
treating oncologist. 


If you have found a study of interest:
 

bullet

Take note of the eligibility criteria, the location of the study, and 
the contact information.

bullet

Take note of the goal of the study.
 
For example, is it a dose-finding (phase I) study,
or a phase II with good preliminary evidence,
or a phase III comparing the study protocol to the the standard of care?

bullet

Print the protocol so that you have something to show the medical providers that you consult

* Most importantly:

bullet Seek and rely on the guidance of *independent* medical professionals, who have training and
first-hand information about your diagnosis and clinical circumstances.

Seeking study options from independent experts in the field is recommended to validate your choices
and to identify study options you may not have considered.


Ask your Treating Physician:

bullet

Review the Consult Checklist below.

bullet

Doctor: "What is the standard of care for my diagnosis and clinical circumstance?

and do you think this (the printed protocol) or some other study is appropriate?"

OR

Contact the Study Investigator Directly:

bullet

Review the Consult Checklist below.

bullet

Call or email the investigator using the contact information on the protocol.

bullet

Ask the investigator to contact your doctor on your behalf to discuss the protocol.

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Seek a second opinion from an independent expert in the field to receive an unbiased opinion.

AND / OR

Consult an Independent Expert:

This is the PREFERRED METHOD because independent experts will have first-hand information about your clinical circumstance, and will also be aware of the important clinical trials, and which are most likely to be appropriate for you - based on your clinical details and the most appropriate goal of therapy. 

By "independent" we mean an expert who will not administer therapy, and therefore has no (unconscious) financial interest in his or her recommendation, and will not limit the conversation to studies provided at their center.  (See also Conflict of Interest in Treatment Decisions PAL)

bullet

Review (by region) a list of experts you might consult under Trial Talk Trial Talk Experts

bullet

Review the Consult Checklist below.

bullet

Doctor: "What is the standard of care for my diagnosis and clinical circumstance?

and do you think this (the printed protocol) or some other study is appropriate?"


Clinical Trials - Consult Checklist:

bullet

Bring a loved one with you to the consult. 
Involving a trusted loved one, even if just to listen, is proven to improve the quality of the consult.

bullet

Provide a copy of your questions in writing ahead of the meeting.
Be concise and indicate which questions are most important to you.

bullet

Questions to ask to include clinical trials in the conversation:

bullet

What is the goal of treatment when treatment is needed?

bullet

What regular treatment is most appropriate to my clinical circumstance and diagnosis ...

bullet

What clinical trials might I consider at this center or elsewhere?

bullet

How is the study different from the regular approach?

bullet

Am I eligible for the study? 

bullet

Will my insurance cover associated costs? 
 
The Patient Protection and Affordability Act (ACA) will help to this problem when
fully implemented - but only if the center is within the network covered
by your insurance (a gap in the ACA).

The sponsor is obligated to pay for the study drug
and special tests that are not part of regular care.

bullet

Is travel or lodging an obstacle (physically or financially)?  
 
See Travel and Lodging for Treatment

bullet

Do other medical providers that you've consulted agree with the recommendation?

bullet

Have the experts you consult contact your treating physicians in order to
reach a consensus on what treatment protocol is best for you.

bullet

Be sure to ask for the reason (the rationale) for the recommendations
(for or against), particularly if you get different opinions.

bullet Review with your doctor the
7 Reasons to Consider Trials based on our clinical circumstances PDF
 
bullet Go back to your treating oncologist and ask for additional advice -
discuss the pros and cons of what was recommended.

Questions to Ask Your Doctor or Nurse about Trial Participation

After discussion of the goal of the next treatment, we recommend starting the conversation about clinical trials by asking: 

What is the recommended regular treatment when treatment is needed? 
By using the word “regular” we can then transition to the follow up question:

What trials can we also consider now, before the need to treat, or when treatment is needed?
What specialists might I consult nearby to inquire about trials?
 

If so:

bullet

What is the purpose of the study?

bullet

How might I benefit from participating?

bullet

What are the known risks from participating?

bullet

What were the results of other studies of this treatment?

bullet

What other treatments could I receive if I don't take part in the study?

bullet

How do the risks and potential benefits of the study compare with the regular treatment?

With consideration of your specific diagnosis, treatment history, and risk factors.

If I join the study:

bullet

How am I protected from possible adverse events?

bullet

What tests are in the study, and how often are they given?

bullet

Can I decide to stop participating at any time?  (Yes, you can)

And if so, will it affect the care I receive? (No, it will not)

bullet

Will I continue to see my current doctor?

bullet

How will participating effect daily activities? Will I still be able to work or go to school?

bullet

Will I have to be in the hospital?   How many days?

bullet

What are the possible risks or side effects for me?

bullet

Will my insurance cover procedures and tests?

If not, will the drug sponsor cover it?

bullet

Will there be extra costs because of the study?

bullet

How will I be checked after the study, and how often?

bullet

How long will the study last and how long will I be tested?

bullet

Will I be made aware of the results?


Important Points About Side Effects:

Side effects and uncertainty about them are not unique to clinical trials.

Here are important points about side effects that may apply to studies. 

bullet

The study doctors do not know who will or will not have side effects.

bullet

Some side effects may go away soon, some may last a long time, or some may never go away.

bullet

Some side effects may interfere with your ability to have children.

bullet

Some side effects may be serious and may even result in death.

Here are important points about how you and the study doctor can make side effects less of a problem:

bullet

Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.

bullet

The study doctor may be able to treat some side effects.

bullet

The study doctor may discontinue or adjust the dose of the treatment to try to reduce side effects.

  

Resources

  1. Doctor Visits - A Checklist to Help You Prepare PAL
  2. Benefits Versus Risks Merck
  3. Conflict of Interest in Treatment Decisions: PAL 
  4. Travel for Treatment
  5. When to Consider Clinical Trials?
  6. Cure Magazine: The Treatment Option You May Be Missing http://bit.ly/bItRI7
  7. Things you can do to get your health insurance to cover a clinical trial cancer.gov ... still an issue until 2014, when the Health Care Reform measure kicks in.
  8. When is conflict of interest most likely to become a factor in medical advice?  PAL
  9. ACT: Please Bring Our Survey to Your Next Consult

    to help start the conversation about trials, and
    also to help identify obstacles to clinical trial referrals.
  10. About PAL's Tools to Locate Lymphoma Trials
  11. Patient-to-patient - CT About finding, evaluating, choosing clinical trials
     
 
Disclaimer:  The information on Lymphomation.org is not intended to be a substitute for 
professional medical advice or to replace your relationship with a physician.
For all medical concerns, you should always consult your doctor. 
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