Brod M; AcademyHealth. Meeting (2005 : Boston, Mass.).
Abstr AcademyHealth Meet. 2005; 22: abstract no. 3797.
The Brod Group, , 219 Julia Ave., Mill Valley, CA 97148 Tel. (415)381-5532 Fax (415)381-0653
RESEARCH OBJECTIVE: The Practical Clinical Trial (or Effectiveness Trial) and the Observational Study (or Registry) are research designs which are well suited to understanding the full impact of treatments in real world settings. These designs, if used with scientific integrity, can address questions not answerable from a randomized clinical trial such as What is the impact of treatment X when patients are not very compliant? However, for these designs to be useful and result in meaningful data, the scientific principles which the designs are based upon as well as best practices for conducting these studies must be understood. Additionally, their limitations must be considered when interpreting the data from these studies. STUDY DESIGN: This presentation will review the scientific principals of the Practical Clinical Trial and the Observational Study designs, identify when these designs are and are not appropriate to use, discuss limitations of the designs and offer suggestions for best practices for conducting these types of studies. POPULATION STUDIED: PRINCIPAL FINDINGS: CONCLUSIONS: IMPLICATIONS FOR POLICY, DELIVERY OR PRACTICE: Data from well designed Practical Clinical Trials and Observational Studies can provide critical information to help understand issues of cost-effectiveness as well as learn more about the practical problems and benefits of treatments in the real world. This important information will enable patients, health care providers and payors to make more informed treatment, reimbursement and formulary decisions.
Publication Types:
Keywords:
- Biomedical Research
- Clinical Trials as Topic
- Cost-Benefit Analysis
- Humans
- Randomized Controlled Trials as Topic
- Research Design
- economics
- hsrmtgs
UI: 103623260
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