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Opportunities and Challenges in Randomized Clinical Trial Activities

This article discusses the wide range of opportunities and challenges in randomized clinical trial activities, including individual trials, methodological and policy issues. Topics covered include the appropriate usage of placebo controls, the establishment of a national placebo working group, data safety and monitoring board policy, reporting practices, and more. The article also highlights specific trials, such as the PROBIT study on breastfeeding intervention and the CANOO1 study on marijuana for chronic neuropathic pain. It addresses methodological issues and the importance of putting clinical trials into context.

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Opportunities and Challenges in Randomized Clinical Trial Activities

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  1. RANDOMIZED CLINICAL TRIAL ACTIVITIES http://jama.ama-assn.org/content/vol302/issue9/index.dtl Opportunities exist in many area Including both Individual Trials and Methodological and Policy Issues

  2. Wide range of policy issues • Appropriate usage of Placebo Controls • National Placebo Working Group set up jointly by Health Canada and Canadian Institute of Health Research (CIHR) to deal with conflicting governmental policies • Data Safety and Monitoring Board Policy • How should accruing safety and efficacy information in clinical trials be handled, including potential conflicts of interest between sponsors and investigators • Reporting Practices • http://jama.ama-assn.org/content/vol302/issue9/index.dtl

  3. Wide range of trials ranging from studies such as PROBIT - Promotion of Breast Feeding Intervention Trial - 17,000+ mothers and infants studied in a Group Randomized ( 32 Hospitals throughout Belarus) RCT which has spawned long-term follow-up of the cohort http://www.epi.bristol.ac.uk/probit3/PROBIT%20III%20Publications.htm to CANOO1 - multi-period cross-over study of efficacy and safety of marijuana in 2 dozen patients with chronic neuropathic pain

  4. Wide range of methodologic issues ranging from • How do we ensure that trials are addressing appropriate questions? to • How is the intention to treat approach being (mis)used?

  5. Putting clinical trials into context Charles Young, Richard Horton www.thelancet.com Vol 366 July 9, 2005 107

  6. 2007/11/05

  7. http://www.sctweb.org/ Personal Disclaimer - In contrast to other presenters unlikely to be available for supervision of theses with horizons past next few years

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