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Check for a Twinkie™

November 22, 2016
Posted by: Joe Martinez, RPh, PDE, PPC

twinkie

Clinical trials cost time, effort and resources to design, recruit, enroll and manage patients through a new therapy.  Health outcomes are collected, compiled and analyzed with much sweat and tears as well as the hope of securing successful and meaningful results.

If the drug or device doesn’t meet the expectation of the study, it could mean the end of the line for that therapy.  The question, thereafter, asked in hushed tones, in dimly lit rooms is: was the drug or device really ineffective, or was there a Twinkie involved?

Yes, seriously. Was there a Twinkie involved?  You read it right the first time. Before I elaborate, please note that this is not an indictment of the Twinkie, one of America’s all-time favorite treats.  Rather, we pose this question to shine the spotlight on human behavior and the potential creative genius inside all of us.

Our story takes place inside a phase 3-phase 3b randomized, double-blind, placebo-controlled clinical trial for a non-insulin glucose lowering medication (NIGLM).  The services of Center Point’s Clinical Trial Research Pharmacist (CTRP®) were brought online to regularly communicate with trial patients to help them maintain a clear understanding of the dosing and directions of the protocol medication.

The assigned CTRP pharmacist was on a routine callback with an enrolled patient when during the course of the telephone conversation the patient divulged that they hadn’t taken matters into their own hands to figure out whether they had been assigned to the medication or the control group being given the placebo.

During the discussion, the CTRP discovered that the patient was eating a Twinkie after each dose of NIGLM and would wait to see if their blood sugar went up or down.  The patient surmised that this would indicate which group they had been assigned to, and if in the treatment group, the strength of the medication as well.

What happened next?  The CTRP explained to the patient about the importance of following trial protocol and the potential negative impact on clinical trials when protocol is not followed.  In addition, the CTRP contacted the clinical site and the sponsor company to brief them about the situation.

A Happy Ending

The end result was positive.  The CTRP was able to catch this early on in the trial so minimal damage was done.  Catching this early on was in large part due to the trusting and respectful relationship that the CTRP had established with the patient at the beginning of the study.   In addition, the clinical site provided additional training for their research associates for the future, and the sponsor company ultimately had their medication approved by the FDA.

Concluding Thoughts

We need to put patients in a position to be successful.  This is important for the health of the patient as well as for the success of any given clinical study. Driving success means ensuring that patients clearly and continuously understand protocol requirements. And to do this, it is necessary for someone from the healthcare team to always be available to answer patient questions and probe further when a red flag appears.

 

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