ST 520 Statistical Principles of Clinical Trials - NCSU Statistics ...

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CHAPTER 1 ST 520, A. TSIATIS and D. Zhang a basic assumption that needs to be satisfied in order to make unbiased treatment comparisons. Luckily, there was a randomized component to the study where the two groups (vaccinated) versus (control) were guaranteed to be similar on average by design. Note: During the course of the semester there will be a great deal of discussion on the role of randomization and compliance and their effect on making causal statements. Government sponsored studies In the 1950’s the National Cancer Institute (NCI) organized randomized clinical trials in acute leukemia. The successful organization of this particular clinical trial led to the formation of two collaborative groups; CALGB (Cancer and Leukemia Group B) and ECOG (Eastern Cooperative Oncology Group). More recently SWOG (Southwest Oncology Group) and POG (Pediatrics Oncology Group) have been organized. A Cooperative group is an organization with many participating hospitals throughout the country (sometimes world) that agree to conduct common clinical trials to assess treatments in different disease areas. Government sponsored clinical trials are now routine. As well as the NCI, these include the following organizations of the National Institutes of Health. • NHLBI- (National Heart Lung and Blood Institute) funds individual and often very large studies in heart disease. To the best of my knowledge there are no cooperative groups funded by NHLBI. • NIAID- (National Institute of Allergic and Infectious Diseases) Much of their funding now goes to clinical trials research for patients with HIV and AIDS. The ACTG (AIDS Clinical Trials Group) is a large cooperative group funded by NIAID. • NIDDK- (National Institute of Diabetes and Digestive and Kidney Diseases). Funds large scale clinical trials in diabetes research. Recently formed the cooperative group TRIALNET (network 18 clinical centers working in cooperation with screening sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand - for type 1 diabetes) PAGE 16
CHAPTER 1 ST 520, A. TSIATIS and D. Zhang Pharmaceutical Industry • Before World War II no formal requirements were made for conducting clinical trials before a drug could be freely marketed. • In 1938, animal research was necessary to document toxicity, otherwise human data could be mostly anecdotal. • In 1962, it was required that an “adequate and well controlled trial” be conducted. • In 1969, it became mandatory that evidence from a randomized clinical trial was necessary to get marketing approval from the Food and Drug Administration (FDA). • More recently there is effort in standardizing the process of drug approval worldwide. This has been through efforts of the International Conference on Harmonization (ICH). website: http://www.pharmweb.net/pwmirror/pw9/ifpma/ich1.html • There are more clinical trials currently taking place than ever before. The great majority of the clinical trial effort is supported by the Pharmaceutical Industry for the evaluation and marketing of new drug treatments. Because the evaluation of drugs and the conduct, design and analysis of clinical trials depends so heavily on sound Statistical Methodology this has resulted in an explosion of statisticians working for th Pharmaceutical Industry and wonderful career opportunities. PAGE 17
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ST 520 Statistical Principles of Clinical Trials - NCSU Statistics ...

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