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In this ISSUE

Why do U.S. Sponsors Come to Russia for Clinical Trials?

Large CROs Adapt to Emerging Biopharma Companies

The Revised Common Rule and New "Concise Summary" Requirements
Industry News
Latest in Business and People News
Catch up on all the latest happening in the clinical trials industry.
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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
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Rare Diseases
The Case for Response Adaptive Trial Design for Rare Diseases
As pharma businesses shift their focus away from 'blockbusters' to treatments for rare diseases, clinical trial design must also go through a period of change and should consider response-adaptive over traditional randomized controlled trial designs.
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Calendar
/ 2nd Annual Direct–to–Patient Clinical Trials – 8/8-8/9 /
/ T3: Trials, Tech, and Transformation — 8/8-8/9 /
/ 3rd Annual Medical Writers Summit — 9/25–9/26 /
/ 4th Annual Lay Summaries Summit — 9/25–9/26 /

Artificial Intelligence
AI Mitigates Clinical Trial Placebo-Response
Dominique Demolle, CEO of Tools4Patient, discusses the effect artificial intelligence is having on the statistical impact of clinical trial placebo response.
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mHealth
MyStudies Platform Brings Patient Experience to Drug Development
MyStudies, introduced by the FDA, bridges data streams to real world evidence by facilitating the collection of real-world data directly from patients in conjunction with a variety of data sources.
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Regulatory Affairs
Too Fast or Too Slow? Debate Intensifies over FDA Regulatory Requirements
Concerns for patient safety are raised with the recent surge in new drugs receiving fast-track FDA approval. Jill Wechsler reports.
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Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
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