FEB
19

CLEAR-III Day-180 Results Presented at International Stroke Conference

CLEAR-III was all the talk at this year's International Stroke Conference (ISC). We had a number of presentations and posters discussing the Day-180 results of this six-year international multicenter trial exploring the delivery of alteplase, a thrombolytic ("clot buster"), via the extraventricular drain in patients with intraventricular hemorrhage (IVH). Thank you to all the clinical site staff and patients that contributed to this trial. There is alway more research needed when dealing with such a serious condition, but the knowledge gained on this project has been invaluable and will shape the future direction of future research for years to come.

Interview with Dr. Daniel Hanley, Co-principal Investigator for CLEAR-III

Photos of the team attending ISC

ISC Media Release

Abstracts and Slides  Dr. Hanley's presentation was LB12. Dr. Issam Awad's presentation was LB13

 Additionally, there have been lots of new articles about the CLEAR III results:

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SEP
09

The Transformation of Clinical Research at BIOS

Much has been written about the escalating costs, slowing cycle times, and long time-to-publication for clinical trials.[1][2] Despite significant effort to harmonize regulations, develop sophisticated data systems and rethink outmoded practices, transformation in clinical research has been much slower than in other industries.[3]

The first off-the-shelf electronic data capture (EDC) systems emerged in the late 1990’s. Despite demonstrated tangible benefits [4], it took more than 10 years before EDC was widely adopted in the pharmaceutical industry; adoption in academic trials has been even slower.[5]  On the site startup side, some 30% of pharmaceutical and medical device companies, as reported in a 2013 NextDocs survey, were still using paper-based files and only 24% were using a dedicated electronic trial master file (eTMF) system.[6] Adoption of centralized (risk-based) monitoring, adaptive designs and similar business and technological innovations has also been painfully slow.

Certainly, a number of factors come into play, but a core obstacle may be that, by definition, clinical trials involve large numbers of people — and people (or their institutions!) can be highly resistant to change. In an informal 2009 clinical site survey by ClinPage, 26% of 629 respondents, 71% being study coordinators, said EDC data were being initially entered from a paper CRF rather than direct data collection. This is surprisingly worse than the 21% in their earlier 2001 survey. Whether this reflects human cultural hesitation, growing institutional fears (over HIPPA, European Data Directive, etc.), or just the ever increasing complexity of studies, much of the value of an EDC system is lost if its implementation does little more than transfer the task of entering intermediary paper case forms (“data collection worksheets”) from the sponsor to the investigator.[7]

BIOS’ experience with the MISTIE clinical development program is a good example of how transformational technology and business process change can reduce time and cost while improving quality. But, more importantly, it serves as an example of how innovation, to be successful, must be implemented in the context of a well-designed plan executed by a skill project management team.

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JUL
11

Grandma Nicki

Grandma Nicki

We missed Nicki at our MISTIE team meeting this week, but it seems she had a good excuse! She is now a proud new grandmother of a beautiful 5.4 pound little girl named Lili who was born on July 8th.  Congratulations Nicki!

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FEB
10

CLEAR-III Closes Enrollment

The 500th and final patient in the CLEAR-III trial was randomized on 14-Jan-2015, closing the enrollment period for this trial. Sites have until the end of January to enter any remaining screens. The trial continues in follow-up with the last patient's last visit (LPLV) expected in February 2016. 

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SEP
16

AVERT Grant Awarded

Dr. David Newman-Toker and the Brain Injury Outcomes (BIOS) coordinating center at Johns Hopkins University are happy to announce that The National Institute on Deafness and Other Communication Disorders (NIDCD), one of the National Institutes of Health (NIH), has awarded funding for the AVERT clinical trial (FAIN U01DC013778). AVERT (Acute Video-oculography for vertigo in Emergency rooms for Rapid Triage) is a randomized controlled trial evaluating the algorithmic application of a diagnostic medical device (video-oculography or VOG)  in the triage of patients presenting to hospital emergency departments with vertigo and dizziness.

The study is expected to randomize 226 patients across 3 U.S.-based clinical sites. The study has been deemed a non-significant risk device trial by the U.S. FDA as it involves a new (investigational) application of this device. VOG devices are currently FDA-approved for measuring eye movements in the assessment of vestibular conditions; they have not been used extensively in the emergency department setting prior to this trial. The study is currently under review by the Institutional Review Boards at the participating sites and is expected to start enrolling next year.

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MISTIE-3 Site Locations