MISTIE INTRACEREBRAL HEMORRHAGE TRIAL

Does faster clot removal in ICH give better patient outcomes?

115 Sites to Qualify:
115
90 Sites to Activate:
77
500 Participants to Enroll:
322

MISTIE III Safety Forum

Please save the date for our

Quarterly MISTIE III Safety Forum

To be held via webinar

Wednesday, April 6th at 1-2pm EDT

 

Registration link: https://attendee.gotowebinar.com/register/6875213595780426243 

 

Principal Investigator and M3 Neurosurgeon attendance is required.

Agenda: 

Hemodialysis Use in MISTIE III Subjects

Vascular Defect Screening in MISTIE III Subjects

Update from our Surgical Centers:  Where We Stand Surgically 

Click here for a video recording of the Safety Forum.

 

 

 

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MISTIE III - 4th Thursday 9am Monthly Webinars Canceled

We have canceled the MISTIE III 4th Thursday Monthly Webinars.

To attend our MISTIE III Monthly Webinars, please join us on the 1st Tuesday of every month at 8am or 2pm Eastern. The registration links for our Tuesday webinars are provided below. Once registered, details of the webinar will be e-mailed to you.

8am: https://attendee.gotowebinar.com/register/6338871822802146305
2pm: https://attendee.gotowebinar.com/register/2492870308800050689

In the event you cannot attend our Tuesday webinar, please visit our website at www.braininjuryoutcomes.com for recordings.

Should you have any questions, please contact Amanda Bistran-Hall at This email address is being protected from spambots. You need JavaScript enabled to view it..

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Join us for our MISTIE III Annual Awards Ceremony!

 

 

 

 

Our MISTIE III Annual Awards Ceremony

 

 

will be held during the monthly webinar

 

 

Tuesday, February 2, 2016

 

 

at 8am and 2pm EST

 

 

Join us and see who will be awarded

 

our Coordinator of the Year for 2015!

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Quarterly MISTIE III Safety Forum has been CANCELED!

 

THIS EVENT HAS BEEN CANCELED.  WE WILL RESCHEDULE FOR THE BEGINNING OF SPRING.

Please save the date for our

Quarterly MISTIE III Safety Forum

To be held via webinar

Wednesday, January 27th at 1-2pm EST

 

Registration link: https://attendee.gotowebinar.com/register/6372093564795161858 

 

Principal Investigator and M3 Neurosurgeon attendance is required.

Agenda TBD 

23
Jul
296
Ag
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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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Brain Injury Outcomes

Johns Hopkins University
1550 Orleans Street
CRB-II, 3M50 South
Baltimore, MD 21231 USA
Office:   (410) 614-6996
Fax: (410) 502-7869
 
24-Hr: (410) 736-1368