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February 18/2020

news roundup

CRO Integrates Bayer’s Small Molecule Research Unit

Germany-based CRO/CDMO NUVISAN will integrate large parts of Bayer’s Berlin-based small molecule research unit. The unit features 400 workplaces and a fully operational team, which includes capabilities and capacities spanning the entire drug discovery value chain.


Open Wearables Initiatives Solicits Open Source Sharing

Open Wearables Initiative (OWEAR) is now actively soliciting open source software and datasets from wearable sensors and other connected health technologies. OWEAR is a collaboration designed to promote the effective use of sensor-generated measures of health in clinical research through the open sharing and benchmarking of algorithms and datasets.


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Advances in RBM Drive the Clinical Trial of the Future
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In this edition

CRO Integrates Bayer’s Small Molecule Research Unit
FDA Approves 70% of New Drugs in Advance of Other Countries


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Survey: Cancer Patients Want to Participate in Trials

Patient Power’s Cancer Clinical Trials Survey results show that the majority of patients surveyed were interested in taking part in clinical trials. However, a little under half stated their medical care team had not discussed clinical trials with them.



Articles

Salary and Employee Satisfaction Survey Results In

Applied Clinical Trials and SCORR Marketing survey report high levels of job satisfaction, but market demand could offer more in the way of compensation and benefits.


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Blog Posts

FDA Approves 70% of New Drugs in Advance of Other Countries

Gains in approving therapies with limited clinical trials and utilizing accelerated review programs, notably to treat rare diseases and deadly cancers were noted by FDA. CDER also reflected a more efficient and predictable review process, as demonstrated by its success in meeting all user fee goals for timely assessments, reviewing 90% of applications in the first review cycle, and approving nearly 70% of new drugs in advance of other countries.


Flawed Approach to Extrapolated Enrollment Data

It is common, and many would assume logical: if the enrollment performance data from an investigator site is known, particularly if there is a lot of this data, one should be able to predict future enrollment performance by extrapolating from this data. Phesi analysis of over 330,000 trial protocols held in our global database shows this approach is flawed.

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Lisa Henderson
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Todd Baker
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