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Medicare Data United with Simple Clinical Trials Expanded (May 2011)

This collaborative “network of networks” was formed to provide the research infrastructure for trials to study comparative effectiveness of therapeutics in the treatment and management of chronic diseases. CMTP led a workshop on CER in Osteoporosis in May 2011.

The Medicare data United with Simple Clinical trials Expanded (MUSCLE) Network was a collaborative “network of networks” formed to provide the research infrastructure for trials to study comparative effectiveness of therapeutics in the treatment and management of chronic diseases. The goal was to initiate large scale simple clinical trials (LSTs) using Medicare data, creating a much more cost-effective approach. (A more traditional cohort design would require extensive follow-up via surveys or additional visits in a clinical setting.) The availability of linked administrative and pharmacy data from Medicare, including Part D prescription drug data, provided an ideal opportunity to conduct studies of chronic disorders that have a significant public health burden for older Americans.

Osteoporosis therapeutics is one area where the options for prevention and treatment continue to increase rapidly, but very little is known about the comparative effectiveness of these drugs and emerging biologics.


In May 2011, the University of Alabama at Birmingham and CMTP conducted a workshop on Comparative Effectiveness Research in Osteoporosis. The workshop convened a diverse group of stakeholders representing researchers, payers, patients/consumers, industry, government and policymakers. The goal was to discuss the methods and strategies for conducting trials for Comparative Effectiveness Research on Osteoporosis and to provide feedback on the feasibility and challenges of developing a network to provide infrastructure for the successful implementation of this type of research. Topics discussed included:

  1. Statistical Methods in LSTs / Accounting for Treatment Heterogeneity
  2. Participant Selection: Designing Inclusion/Exclusion Criteria
  3. Study Arms: Selecting Appropriate Comparators and Intervention Parameters
  4. Outcomes: Selecting Appropriate Primary and Secondary Outcome Measures and Defining Intensity of Follow-up
  5. Data Management and Medicare Data Linkage
  6. Practical Considerations for Conducting LSTs in Practice-Based Research Networks.

Insights from the meeting have directly influenced the proposed design of a real pragmatic clinical trial in osteoporosis treatment called the “Active comparator OsTeoporisis Large Simple Trial (ATLAST).  Given the growing demand for novel methods to conduct low-cost, high quality comparative effectiveness research, the MUSCLE network approach has potential to become a new model for conducting real-world clinical trials across multiple areas of chronic disease.
For more details, review the meeting summary and position paper.

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