Tag Archive: enrollment

Jan 17

Enrichment Strategies for Clinical Trials

On 14 December 2012, the FDA released the guidance Enrichment Strategies for Clinical Trials to Support Approval for Human Drugs and Biological Products.  The guidance is intended to provide strategies for drug developers to enrich enrollment for responder subjects in both early and pivotal clinical trials.  Often, simply enrolling subjects that have the disease that …

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Jun 25

Clinical Trials in the Facebook Age

On 07 Jun 2011, Pfizer initiated a clinical trial pilot to assess safety and efficacy of Detrol LA, which is a treatment for overactive bladder (OAB).  The trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience), was the first completely “virtual” trial ever designed.   The trial was set-up to compare if a completely virtual …

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Nov 02

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to lag behind and often do not recognize that project management is not too complex or …

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Jul 20

Choose Canada for Your Next Clinical Trial

When it comes to the state of the life science industry in Canada, the critics are numerous.  The past two to three years have been difficult and those that lie ahead are still quite uncertain.  With the growing competition at various levels from emerging countries, it is crucial to not only assess our weaknesses but …

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Mar 30

Social Media in Clinical Trials: Increasing Patient Recruitment

Sources used to access health and wellness information

When you become sick with a virus or are seeking information about a diet, where’s the first place that you turn to for help? Is it the doctor’s office or the internet? A recent study showed that the percentage of American adults that had access to the internet rose from 46% in 2000 to 74% …

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May 24

When Should You Write your Statistical Analysis Plans?

Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of study. I find this unusual. Any experience doing so? When? As of the time of …

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