Tag Archive: protocol

May 21 2012

Stem Cells: Which Way to the Clinic? (Updated!)

For over two decades, the potential of stem cell therapy to cure some of our most devastating diseases has been touted by the media.  A Google search of “stem cell research” yields over 57 million results, and yet, in mid-2012, there is only one approved stem cell product on the market in the United States …

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Nov 02 2011

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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May 26 2011

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

Apr 28 2011

Statistical Reviews of Case Report Forms

A statistical review of a trial case report form (CRF) is highly important for various reasons. The project statistician is aware of the planned primary and secondary endpoint analyses and knows what data will be needed to implement these analyses. The project statistician also has a clearer view of how the data will affect the …

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Apr 15 2011

Protocol Development: Focus on the Right Objectives

Every clinical study starts with the development of a clinical protocol, a document that describes how a clinical trial is to be conducted.  Clinical protocols are not only a regulatory/GCP requirement, but are absolutely essential to ensure a clinical study is conducted appropriately and consistently, which ultimately ensures the safety of the trial subjects and …

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Apr 07 2011

Clinical Trials in South Africa 101

South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment for seasonal diseases can be maintained when the seasons change in the northern hemisphere. Trials …

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Sep 27 2010

Annual Reports: A Time for Reflection

You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year?  Quite possibly.  In the rush to keep things moving, it’s all too easy to not take the time to pause and get a healthy dose of perspective.  Enter annual reports for drug/biologic development …

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Sep 09 2010

Statistics and Statisticians in Clinical Trials – Beginning with the End in Mind

Cover of The 7 Habits of Highly Effective People Begin with the end in mind … is imagination–the ability to envision in your mind what you cannot at present see with your eyes. It is based on the principle that all things are created twice. There is a mental (first) creation, and a physical (second) creation. …

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Jul 26 2010

Statistical Implications of Protocol Amendments

Clinical trial protocol amendments occur for good reasons. An unanticipated safety issue may arise, new information about the disease or treatment may suggest alterations, or recruitment and enrollment may not go as planned. One aspect of protocol amendments that often gets overlooked is the statistical analysis. This is because it is not always obvious that …

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May 24 2010

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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