CLEAR IV Webinar Recording Now Available!

Hello Everyone,

       Here is a video link to Dr. Daniel F. Hanley's webinar presentation on the CLEAR IV trial, which took place on November 7th, 2017. The video includes a comprehensive overview of the design, justification, and science behind the CLEAR IV trial. If you have any questions, feel free to contact myself (This email address is being protected from spambots. You need JavaScript enabled to view it.), Amanda Bistran-Hall (This email address is being protected from spambots. You need JavaScript enabled to view it.), or any BIOS team member. Thank you and enjoy!

- Hasan

 

 

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M3 November Monthly Webinar: CLEAR IV Takeover

Learn the next steps as we plan to embark on the CLEAR IV Trial!

 

Tuesday, November 7th at 8am and 2pm EST.

 

You must be registered to attend.

 

8am: https://attendee.gotowebinar.com/register/1383745654482714115

 

 

2pm: https://attendee.gotowebinar.com/register/7592602054626842115

 

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MISTIE 3 in the final stretch!

The MISTIE III clinical trial, evaluating catheter-delivered thrombolysis for the treatment of intracerebral hemorrhage, is on track to complete enrollment in mid-2017.  The 400th patient, out of 500 planned, was enrolled on 01-November!

Currently, there are 62 active sites which have screened over 15,000 subjects. There were 173 patients enrolled over the trailing twelve months, for an average of 14.4 patients randomized each month, albeit there is notable month-to-month variability with enrollment generally being higher in the winter months. Extrapolating, that suggests that enrollment should complete by June, which would be two months ahead of plan. Follow-up of the last enrolling patient should be complete 12 months later.

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Save the Date: MISTIE III Quarterly Refresher

Our next Quarterly Refresher will be held:

 

Thursday, November 10, 2016 

10am - 2pm EST

 

Registration link: https://attendee.gotowebinar.com/rt/8885372643073065986 

Once registered, details of the webinar will be e-mailed to you.

 

Please contact Amanda (This email address is being protected from spambots. You need JavaScript enabled to view it.) with any questions.

 

Future Refreshers:

February 9, 2017

May 11, 2017

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MISTIE III Enrollment Review for July 2016

 

As of end-July 2016, we are at 356 enrollments (of 500). Over the trailing 12-month period (TTM), we have enrolled 178 subjects, an average of 14.8 per month. The number of actively-recruiting sites each month (activated less closures and temporary holds) is relatively stable at around 75 sites, and it seems likely that the current average enrollment rate will continue. Extrapolating, we are therefore on track to complete enrollment in around 10 months (May-2017), about 2 months ahead of plan. In our enrollment data, there is notable month-to-month variability, a possible seasonality effect, and a limited performance history with the later-starting ex-US sites that suggest a 2-month collar is reasonable (e.g., enrollment should complete in Mar-Jul period).

 

  

Enrollment at the Australia-Asia sites, managed by the George Institute (GI or TGI), is averaging around 0.75 randomizations per month (over the TTM period). At this rate, they will contribute around 20 to 24 subjects by enrollment completion.

Enrollment in the MTI substudy (across 23 of the M3 sites) is proceeding smoothly at approximately 4.3 subjects per month.  At completion of enrollment in the overall trial, there should be approximately 90 subjects in this substudy (red line in the graph below).

 

 

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