Aloha! BIOS at the International Stroke Conference!


Aloha Friends! In just a few short days, we will be in sunny Honolulu at the International Stroke Conference. In addition to our CLEAR III Annual Meeting on Tuesday night, we have many other exciting programs and presentations during the conference. Continue reading for details on all events. We hope to see you there!  

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Clinical Trial Participation and Placebo: The Unsung Heroes During Consent Discussions

From the perspective of a patient or a patient’s family during the time of a medical crisis the idea of consenting to an investigational trial can be very stressful. Most will focus on the risks of the investigational therapy and will find it difficult to realize the inherent benefits of participating in a clinical trial and the possible benefits of receiving a placebo. Historically the mortality rate of a patient suffering an intraventricular hemorrhage can be as high as 80% per the literature. In comparison, a review of the IVH thrombolysis safety (Safety) trial unblinded data shows that participation in a clinical trial reduced mortality to about 20% in both treatment groups. Although the treatment assignments remain blinded, this appears to be holding true for the current CLEAR III trial as well with 30-day mortality below 40% in both treatment groups. An assessment of A/B mortality is done by a blinded statistician at the time of each death to ensure that survival is occurring at the expected rate in both groups. This trend of survival in subjects enrolled in the trials is attributed to the stringent stability protocols required by the protocol which include optimal catheter placement, daily CT scans to monitor for bleeding, and strict blood pressure and intracranial pressure management.

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CLEAR-III DSMB compliments study team

The Data Safety Monitoring Board (DSMB) for the CLEAR-III clinical trial met today to review detailed data on the first 175 patients in the trial (152 post Day-180), with additional preliminary data from a total of 251 enrolled patients from across 61 clinical sites. CLEAR-III is a phase III clinical efficacy and outcomes study assessing the effect of external ventricular drainage (EVD) with rt-PA or placebo to treat intraventricular hemorrhage (IVH). The first subject, out of a planned 500, was enrolled in September 2009.

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CLEAR-III Coordinator of the Year

Coordinators of the Year 2012 attending the ISC Meeting in Honolulu next FebruaryEach July the BIOS coordinating center hosts an annual awards meeting where we honor those coordinators that have made exceptional contributions to this clinical trial over the last fiscal year. One of the most anticipated events during this meeting is the CLEAR-III Coordinator of the Year announcement. In keeping with our ThrombOlympics theme this month, we renamed the award as the gold medal and played the Olympic theme in the background, adding to the excitement. In very close competition, we had a tie and two coordinators won the gold medal this year:  Terry Cole from Rush University and Julie Martinez from the University of Utah.

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The CLEAR-III World Cup Competition

World Cup ChampionsJuly 1st is the start of the 4th fiscal year for the CLEAR-III trial (the first patient enrolled in Sep-2009). And this year we are introducing a new friendly competition called the CLEAR-III World Cup. Similar to international soccer competitions, regional groups of 3 to 5 clinical sites will be organized into teams. The teams will score points based on achieving certain performance goals such as having a randomization, resolving queries promptly, or completing a patient visit within the expected visit window.

The idea for this unique and exciting competition came from from one of the BIOS Reading Center staff, Sam Tak. Sam has created a wonderful new opportunity to enhance internal collaboration at sites and to foster camaraderie among the trial sites. Of course, we'll use our VISION-EDC system to track each teams scores on a real-time basis.

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CLEAR-III Enrollment Graph
CLEAR 3 Enrollment Graph
Last Updated: 16-Jan-2015