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I am pleased to share to with you my letter-to-the-editor from the Feb 20th, issue of NEJM (p 781). I responded to a Nov 14th, National Heart, Lung, and Blood Institute...

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Outcomes Research

Randomized controlled trials (RCTS) for rare diseases are often underpowered and brief in duration, leaving many important clinical questions unanswered.  Churchill's real-world outcomes research protocols are designed to complement RCTs and improve patient outcomes.  Our protocols strategically assess quality of life, validate best practice guidelines, and evaluate the routine use of newer therapeutic interventions over longer timeframes in larger populations of patients with rare diseases.

 Studies

  • Disease and product registries
  • Quality of life assessments
  • Patient reported outcomes
  • Clinical practice surveys
  • Electronic medical records reviews
  • Claims and epidemiology database studies
  • Meta-analyses and systematic literature reviews

Statistics

  • Sample size determination
  • Data validation
  • SAS and SPSS programming
  • Interim and final analyses

Support

  • Investigator innitiated study project management
  • Survey design and validation
  • IRB Documentation and submission
  • Site evaluation, training, and monitoring
  • Database development and management
  • Data collection and data entry
  • Posting on www.clinicaltrials.gov

 

 

 

 

 

 

 

 

 

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