Adaptive Clinical Trials: Separating Fact from Fiction
Part of eCliniqua's continuing series on adaptive clinical trials.

By Deborah Borfitz

For sponsoring companies, adaptively designed studies are not an easy segue from the traditional drug development approach where data analysis and decision-making happen on the back end of a clinical trial. Different attitudes and infrastructure -- and a whole new set of ground rules -- must be put into play.

Statisticians hold a special position in this Brave New World, as they're often the "gatekeepers of all this is quantifiable," says Trevor Mundel, MD, global director of the immunology and infectious disease business franchise of Novartis Pharmaceuticals. "The unfortunate thing is that [statistics] are a black box to a lot of those who run studies, implement them, and make decisions about committing resources to studies." Thus, a fair amount of decision-making power gets handed to the number crunchers.

This is problematic only if in-house statisticians are rigid about "statistical purity" in all they do, says Mundel. "The truth is, some [statistical] techniques have been carefully worked on and the theories are well understood and usually lead to the right conclusion...but in the real world, there's no proof that they actually work." These include the routine practice of "analyzing data repeatedly over time when patients are dropping out of the study for various reasons." Read more.

LIFE SCIENCE JOBS

Paradigm-Sales/Business Development – IT Solutions and Services
Paradigm (www.Paradigminfotech.com) is a global IT services and solutions provider. Paradigm has over 1000 employees and is the recipient INC. 500 and D&T Fast 50 consistently.  Paradigm is looking for SALES / BUSINESS DEVELOPMENT PEOPLE.  Experience: 2-3 years Direct sales experience in Software Solutions or Services including Application development or support and preferably selling to Pharmaceutical, CROs or Health care industries. Location:Columbia, MD,Contact:  Erin Lowman, erin@paradigminfotech.com, 410-872-1008 x 100Mayo Clinic – Job #19191 - Unit Head – IT
Location:  Rochester, MN.  Oversee software development and support for research and operational activities for Health Sciences Research and Nursing Research departments. Recruit, manage, and mentor IT personnel; provide budget administration, client/vendor management, strategic planning and project coordination, planning, and estimating. Qualifications:  BS degree in computer science or similar field (master’s in computer science, management or health/clinical informatics desirable), and 6+ years’ professional IT.  Apply online at: www.mayoclinic.org/jobs-rst.

Lexicon Pharmaceuticals, Inc. - Systems Administrator (23835)
A biopharmaceutical company focused on discovering breakthrough treatments for human disease seeks a highly qualified Systems Administrator with Unix background to maintain the Unix computing environment high-performance computing systems and laboratory devices in our Princeton, New Jersey location.  Candidates experienced in Cheminformatics and/or high performance computing (HPC) are highly preferred.  Oracle Database Administration expertise is a plus.  for complete details on this position visit: http://www.lexpharma.com/careers/opportunities.php For immediate consideration, please send your CV to opportunities@lexpharma.com.

Mayo Clinic – Job #19178- Unit Head – IT
Location:  Rochester, MN.  Responsible for project coordination, planning and estimating, as well as budget administration, client/vendor management and strategic planning; plus coordinating technical resources that support research projects, journal publications, grant/contract preparation and scholarly activities. Qualifications: BS degree in computer science or a related field plus 6+ years’ IT experience.  Apply online at: www.mayoclinic.org/jobs-rst.

Titian Software - US Support Engineer
Become a key member of our Support staff by providing “best in class” services to our customers. Investigate, diagnose, resolve, and be responsible for resolution of customer support issues and liaise with our UK Software Development team to suggest, request and perform code and product changes based on field experience. For more information and to apply: http://www.titian.co.uk/Careers/Vacancies.asp 

Lilly Singapore Center for Drug Discovery (LSCDD) - Associate Director of Informatics,
Lead and mentor a strong team for the Bioinformatics group at the Integrative Computational Sciences (ICS) department at LSCDD towards the development of novel algorithms, data analysis methods and software tools for drug discovery. Work closely with the Software Engineering group at ICS, and collaborate with the Discovery IT organization in Europe and USA. For additional information, or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery (LSCDD)- Senior Bioinformatics Scientist,Contribute to the development of novel algorithms, data analysis methods and software tools for drug discovery as part of the Integrative Computational Sciences (ICS) department at LSCDD.  Work closely with informatics and software engineering peers at ICS, and collaborate with the Discovery IT organization in Europe and USA. The successful candidate will offer hands-on insight and expertise in tailored therapeutic informatics and statistical analyses at the post-genomic era. For additional information, or to apply visit: LSCDD   

Lilly Singapore Center for Drug Discovery(LSCDD) -Senior Software Engineer,
Join a strong team of software engineers in our Integrative Computational Sciences (ICS) at LSCDD. Collaborate with, and help develop integrated applications to process and visualize data from cutting-edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. The Software Engineering team provides computational tools and tailored software solutions that enable the global effort of Tailored Therapeutics; ‘The Right Drug, at The Right Dose for The Right Patient at The Right Time'. For additional information, or to apply visit: LSCDD  

FEATURED EVENTS

The 1st Symposium on Protein Tomography -- May 1, 2008, Boston, MA 

InforSense Translational Research Symposium, May 2,2008, Boston, MA

Put MIT to work for you - ASP Info Session May 6,  Cambridge,MA 
 
The Post-Approval Summit  May 14-15, 2008, The Conference Center, Harvard Medical School, Boston, MA

TEPR 2008 -- May 17-21, 2008 Ft. Lauderdale,FL