Feb 25, 2013

12 Free Cancer Clinical Research Operation Online Self Learning Modules

National Cancer Institute, Center for Cancer Research provides education and training materials for cancer researchers (e.g., research nurses). The Clinical Research Operations Online Self Learning presentation serial provides a basic overview of clinical research. 
If you are new to clinical trials, you will find easier to learn below modules in the following order. Select the 1 slide per page for initial viewing and hyperlink capability. The 6 slides per page is an option for printing as needed.
  1. Clinical Trial Design: 1 slide per page or 6 slides per page
  2. Protocol Development: 1 slide per page or 6 slides per page
  3. Phase 0 Clinical Trials: 1 slide per page or 6 slides per page
  4. Informed Consent Process: 1 slide per page or 6 slides per page
  5. Roles and Responsibilities of the Research Team: 1 slide per page or 6 slides per page
  6. Roles and Responsibilities of the Sponsor: 1 slide per page or 6 slides per page
  7. Clinical Data Management: 1 slide per page or 6 slides per page
  8. Documentation in Clinical Research: 1 slide per page or 6 slides per page
  9. Documenting, Recording, and Reporting of Adverse Events and Unanticipated Problems: 1 slide per page or 6 slides per page
  10. Regulatory Binder: 1 slide per page or 6 slides per page
  11. RECIST: Applying the Rules (optional): 1 slide per page or 6 slides per page
  12. Monitoring and Auditing of Clinical Trials: 1 slide per page or 6 slides per page
Resource: Accrual Net

Feb 24, 2013

N-of-1 | single subject clinical trials

The interest in evidence-based, as well as individualized medicine, has led to some very notable discoveries.

An N of 1 trial is a clinical trial in which an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. A trial in which random allocation can be used to determine the order in which an experimental and a control intervention are given to a patient is an N of 1 randomized controlled trial. The order of experimental and control interventions can also be fixed by the researcher.

The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. The single case experimental design has been very effective in psychology and other field of behavior science.

ref: Wikipedia

Feb 14, 2013