I recently posted an article, "Top 10 Facts You Need to Know about Clinical Trials." Now, let's explore the top questions you need to ask clinical trial leaders -- including the principle investigator and the medical team -- so as to effectively evaluate and support your loved one through a specific clinical trial that your loved one is considering.**
1.What do you know about this drug or procedure?
Be sure to find out how many animals and/or people have been tested to date; what the results were; what phase of testing the clinical trial is in; and the safety profile of the drug or procedure -- including possible adverse reactions. Ask about a website where you can find out more information about the history of this clinical trial.
2.What are some possible benefits and risks?
Find out exactly how the treatment might improve your loved one's condition in the best-case scenario, and identify the risks involved -- everything from adverse to fatal reactions. Ask about how the treatment may affect your loved one's quality of life, and find out what symptoms to look out for and whom to call in case of side effects: What changes should you note and report immediately?
3.What are the protocol requirements?
Find out how many appointments will be required weekly, monthly and overall; how long the appointments will be; where the appointments will be held; what procedures, tests or scans will be involved; what specific challenges these may pose for your loved one; how many medications will be required; how frequently the medications will need to be administered; and what data will need to be tracked and how often. Ask if there are other protocol requirements you should know about.
4.What is the structure of the protocol?
Ask the study coordinator how many individuals are participating in a given trial and what the guidelines are for that trial. Find out if there will be a placebo group and who, or what, will the results be compared to. Determine what exactly the investigators are looking for in the trial, and therefore, at what point the treatment will be terminated. For example, are the investigators looking for halting the progression of disease or for catalyzing the remission of disease? If the disease continues to metastasize or progress, will the patient therefore be eliminated from the study?
5.Who is responsible for the study?
Ask about the credentials of the primary investigator and medical team, and find out how many studies they have conducted in this field and regarding this particular health condition.
6.Who pays for what?
Find out which expenses are covered by the clinical trial, which may be covered by your health insurance company (be sure to verify with your insurance representative) and which will be out-of-pocket.
7.Will we have access to the treatment?
See if this clinical trial offers a compassionate drug use program. If it does, your loved one will have access to the treatment before it is available in the market, assuming s/he has responded well to the treatment during the trial.
8.Are there possible contraindications?
Make sure the principle investigator and medical team are familiar with all the therapies your loved one is using. If they are not, see if they will speak with your loved one's healthcare providers, to evaluate whether there are possible contraindications. Make sure you know if certain treatments must be stopped before participation in the trial.
9.What is the ultimate goal of this study?
Find out how the information from the study will be used, and ask about the next steps after the clinical trial.
10.What are some other options?
In case this clinical trial does not seem to be a good match, ask the trial leaders what other options might be available to your loved one.
As you consult with your loved one and weigh the pros and cons of participating in the trial, do include your own needs as a factor to consider -- specifically, the feasibility of the extra caregiving duties required by the clinical trial. Do also share your honest thinking about the various risks and benefits of the trial. Keep in mind, however, that the decision is ultimately your loved one's to make; after all, it is her or his own life at stake, and therefore, choice to make.
**Special thanks to:
John Schall, CEO Caregiver Action Network
Ken Getz, founder and board chair of the Center for Information and Study on Clinical Research Participation (CISCRP)
Craig Lipset, Head of Clinical Innovation at Pfizer Worldwide Research & Development
Dr. Sean Mackey, MD, PhD, Chief of the Division of Pain Management at Stanford University
Rebecca McCue, division research manager of the Stanford Systems Neuroscience & Pain Laboratory (SNAPL)