Ther Innov Regul Sci
Survey of Customers Requesting Medical Information: Preferences and Information Needs of Patients and Health Care Professionals to Support Treatment Decisions.
Fung SM, Sud C, Suchodolski M
Pharmaceutical manufacturer medical information (MI) departments play an important role in providing medical information to health care professionals ...
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Source: PubMed
Ther Innov Regul Sci
The Power Derivative Principle, and Its Application to How and When to Perform a One-Shot Unblinded Reassessment Sample Size.
Blondiaux E, Derobert E
In adaptive two-group clinical trials, a current method is to perform a one-shot unblinded sample size reassessment. Whereas the interim unblinded loo ...
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Source: PubMed
Ther Innov Regul Sci
Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III Trials.
Guinn D, Wilhelm EE, Shoulson I
Confirmatory phase III trials aim to provide decisive evidence about a medical product's safety and efficacy. Although these trials are planned and co ...
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Source: PubMed
Ther Innov Regul Sci
Adaptive Designs: Results of 2016 Survey on Perception and Use.
Hartford A, Thomann M, Chen X, Miller E, Bedding A, Jorgens S, Liu L, Chen L, Morgan C
The DIA Adaptive Designs Scientific Working Group has a devoted subteam to performing surveys, literature reviews, and registry reviews every 4 years ...
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Source: PubMed
Ther Innov Regul Sci
Investigation of the Influencing Factors on the Incidence of Vertebral Fracture: A Meta-analysis Based on Placebo Data of Randomized Clinical Trials.
Kobayashi T, Kaneko M, Narukawa M
The incidence of vertebral fracture is commonly used as a primary endpoint in randomized clinical trials of pharmaceutical agents for osteoporosis. In ...
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Source: PubMed
