Sunday, August 11, 2013

Clinical Trials ... A Caregiver's Recommendations

My wife recently participated in a major international Phase III clinical trial of a potential new medication for those with early stage Alzheimer’s Disease (AD). Based upon my experience as a spouse/caregiver, I have three recommendations to improve the clinical trial process.
My first recommendation is that clinical trial protocols should allow doctors to inform patients about whether they received medication or a placebo as soon as the patient’s trial participation ends. My wife’s trial lasted one year but she had to wait another year until all participants had completed the trial before learning whether she had received the experimental medication or a placebo. However, my wife also has a serious heart condition and her cardiologist wanted her to begin a new medication. Since this was a double blind trial, not even her AD doctors knew if she had received actual medication or a placebo. If my wife had been receiving the placebo, there would have been no cause for concern. But if she had been receiving the experimental medication, the cardiologist would have preferred a suitable “wash period” before beginning new heart medication. The clinical trial supervisor would not release that information, even though their clinical trial data would be totally unaffected. Protocol directives therefore denied her cardiologist knowledge that led to an unnecessary risk.  Directives not in the patient’s best interests should never be part of any clinical trial protocol. Patients should have the right to learn about the medication or placebo they received as soon as their participation in the trial is over.

My second recommendation is that clinical trial medications/placebos should only come in user-friendly packaging. My wife’s pills came in what is commonly referred to as blister package cards … cards with tiny plastic ‘blister bubbles’ that must be firmly pressed to remove each individual pill. What are the manufacturers thinking? AD patients are mostly elderly, as are their caregivers, and they should not have to experience physical pain and mental stress just to open their pill ‘container’ three times each day! My wife and I found it extremely difficult and time consuming to remove each individual pill. Pharmaceutical companies should be making life easier for patients, not more difficult! All medication for elderly patients in clinical trials should come in easy to open, user-friendly plastic containers!
My final recommendation is that clinical trial protocols for interviewing patients and caregivers need revision. My wife and I were interviewed together at several junctures during the trial. These joint interviews were emotionally difficult for both of us. When asked if my wife had demonstrated a particular AD behavior, if she said no but I said yes it made for a very uncomfortable situation … in the doctor’s office, on the way home, and later that night! (I know of spouses who have knowingly lied at joint interviews simply to maintain marital harmony.) If interviewed jointly, the caregiver should be told that only the patient’s responses are being requested at this time, and that the caregiver will have the opportunity to comment further during a future interview. Especially with diseases such as Alzheimer's, when many patients are in denial about their symptoms … and especially when the caregiver is the patient’s spouse … protocol directives should not place patients and their spouse/caregivers in unnecessary emotionally strained situations. Clinical trial protocols should provide for separate interviews of patients and caregivers to insure an accurate assessment.
Hopefully, one or more of these recommendations will be implemented in a future clinical trial protocol. Participation in clinical trials are, by definition, time-consuming commitments that can, on occasion, be very stressful. There is no need to add unnecessary stress to that experience!
 
Published in Clinical Trials, Journal of the Society of Clinical Trials, October, 2011, Vol. 8, p. 679. Access at:  http://ctj.sagepub.com/content/8/5/679
 

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