Small Clinical Trials: Issues and Challenges

Description

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Get the book

Amazon.com

Search the book

eBay.com

Search the book

Other editions

• 

  Small Clinical Trials: Issues and Challenges

  • 2001-02-01
  • 221 pages
  • Paperback
  • National Academies Press

Similar books

• 

  How Institutions are Shaping the Future of Our Children: For Better or for Worse?

  By Catherine Dulmus, Karen Sowers

  Lammert, M., & Timberlake, E. M. (1986). Termination of foster care for the older adolescent: Issues of emancipation and individuation.

• 

  Reversibility of Chronic Disease and Hypersensitivity, Volume 5: Treatment Options of Chemical Sensitivity

  By William J. Rea, Kalpana D. Patel

  Dou, L., E. Bertrand, C. Cerini, V. Faure, J. Sampol, R. Vanholder, Y. Berland, P. Brunet. ... A. Timberlake, B. Sumpio, R. Pfragner, I. M. Modlin, M. Kidd.

• 

  Rockwood and Green's Fractures in Adults

  By William Ricci, Charles M. Court-Brown, Margaret M. McQueen

  Chendrasekhar A, Moorman DW, Timberlake GA. An evaluation of the effects of ... Chittiboina P, Wylen E, Ogden A, et al. Traumatic spondylolisthesis of the ...

• 

  Breast Pathology, An Issue of Surgical Pathology Clinics

  By Laura C. Collins

  Hartmann LC, Radisky DC, Frost MH, et al. Understanding the premalignant potential of ... D'Alfonso TM, Wang K, Chiu YL, et al. Pathologic upgrade rates on ...

• 

  Telepractice in Speech-Language Pathology

  By K. Todd Houston

  Stensland, J., Speedie, S., Ideker, M., House, J., & Thompson, T. (1999). The relative cost of outpatient ... Deal, J. L. (1987). Appraisal and diagnosis of ...

• 

  Addressing Adversity: Prioritising adversity and trauma-informed care for children and young people in England.

  By Marc Bush, Lord Victor Adebowale, Rebecca Adlington

  1 2 Howard, S. and Johnson, B. (2000) Resilient and Non-resilient Behaviour in ... 4 De Haan, L., Hawley, D. and Deal, J. (2002) 'Operationalizing family ...

• 

  Culture, Brain, and Analgesia: Understanding and Managing Pain in Diverse Populations

  By Mario Incayawar, Knox H. Todd

  ... are not fluent in the language/s of the medical care provider.72 Research ... Anglo-Americans have traditionally placed a great deal of emphasis on the ...

• 

  Image-Guided Spine Interventions

  By John M. Mathis

  This practical guide thoroughly discusses both well-established and new interventions that are applied to the spine for the purpose of pain relief.

• 

  New Mynursinglab -- Access Card -- For Maternal-Child Nursing (24-Month Access)

  By Pearson Education, Pearson Education, Inc., David P Pearson Education

  Several versions of Pearson's MyLab & Mastering products exist for each title, including customized versions for individual schools, and registrations are not transferable.

• 

  Pearson's Medical Assisting (General)

  By Pearson Education Staff, Madan Dr Pearson Education

  If a picture paints a thousand words, imagine what video can do? Pearson Medical Assisting Videos help users learn the nuances and the details of many medical assisting procedures.