Equigen Antiepileptic Bioequivalency Trial

Are the generics as good as the brand name?

Steve Mayo

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President of Emissary International (www.Emissary.com) the CRO supporting CLEAR and MISTIE programs. Steve is known in the CRO industry as "SuperMonitor" due to an article he wrote many years ago about life as a clinical research associate. Steve enjoys photography, travelling to far-away places, hiking with his son, and web design. He maintains several websites: http://www.Troop-201.com and http://OmniVesting.com

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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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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Welcome to the EDGE Newton-2 Study!

Edge Therapeutics Logo

The BIOS team at Johns Hopkins University is delighted to be a part of Edge Therapeutics' clinical trial Newton-2 (Protocol #EG-01-1962-03) evaluating a new treatment for certain patients with aneurysmal subarachnoid hemorrhage (aSAH). Our goal at BIOS will be to ensure that the blinded assessors at the clinical sites are well versed on the neurologic outcome assessments in this trial. Because the outcome on the GOSE rating scale is the primary endpoint in this study, it is imperative that the assessor has a thorough understanding of the survey methodology, including the ability to perform a thorough assessment of the extent of disability at baseline, prior to the aSAH. We are providing this online training course, assessment tools, and informational updates. Please see the menu for these materials.

Additionally, please feel free to contact us with any questions you may have. Meanwhile, we look forward to working with you!

 

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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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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