Sections View Full Chapter Figures Tables Videos Full Chapter Figures Tables Videos Supplementary Content ++ RANDOMIZED CONTROLLED TRIAL ++ Refer to Chapter 4, Drug Literature Evaluation I: Controlled Clinical Trial Evaluation ++ PHARMACOECONOMIC ANALYSIS ++ Refer to Chapter 6, Pharmacoeconomics ++ NONINFERIORITY TRIAL ++ Is the reference drug’s efficacy established using adequate historical data and/or addition of a placebo arm? Are the participants and outcome measures for the noninferiority similar compared to previous studies that confirmed the efficacy of the reference drug (e.g., constancy assumption)? Is the method used to determine the noninferiority (NI) margin predetermined before the study, both clinically and statistically sound, and the reasoning clearly stated in the article? Was a per-protocol analysis used? If so, did they also perform an intention-to-treat analysis? Was the sample size modified as the study progressed? If so, was a clear explanation of how the blinded information was handled and by what method these modifications were determined also provided? Was this study an attempt to rescue a failed superiority trial? ++ N-OF-1 TRIAL ++ Was assignment of active and control treatment to study periods randomized? Was the study blinded? Were multiple observation periods used? Were study endpoints clearly defined? Was the washout period between study periods adequate? ++ ADAPTIVE CLINICAL TRIAL (ACT) ++ Are the methodologies used to make adaptive changes in the trial adequately described? What logistical issues exist and have they been adequately addressed? Are the adaptive changes based on evidence and good clinical judgment? Did extensive adaptation to the protocol occur during the study? To what extent is intrusion of bias noted? Who has access to the information created from interim analyses? If the study was stopped early, is the totality of evidence adequate? ++ STABILITY STUDY ++ Were study methodologies and test conditions clearly defined? Were validated assays used? Were assays validated using time-zero measurements and an adequate number of test samples taken? ++ BIOEQUIVALENCY STUDY ++ Did the protocol define the characteristics of the subjects? Were confounding factors (e.g., smoking, alcohol use) identified and controlled? Was a crossover design used? Was the study randomized and blinded? ++ PROGRAMMATIC RESEARCH ++ Were one of two options used for subject comparison: (1) comparison of subjects to those not using the program or service, (2) comparison of subjects before or after initiation of the program or service? Was the program or service clearly defined? Did the authors specify from whose perspective (e.g., patient, provider, physician, third-party payer) the study was undertaken? If costs were analyzed, were all costs associated with provision of the program or service included in the analysis, including personnel, inflationary changes, and cost savings had the intervention not occurred? Were clinically important outcome parameters used to assess effectiveness of the program or service? ++ COHORT STUDY ++ Was the research question clearly stated?... GET ACCESS TO THIS RESOURCE Sign In Username Error: Please enter User Name Password Error: Please enter Password Forgot Username? Forgot Password? Sign in via OpenAthens Sign in via Shibboleth Get Free Access Through Your Institution Contact your institution's library to ask if they subscribe to McGraw-Hill Medical Products. Access My Subscription GET ACCESS TO THIS RESOURCE Subscription Options Pay Per View Timed Access to all of AccessPharmacy 24 Hour $34.95 (USD) Buy Now 48 Hour $54.95 (USD) Buy Now Best Value AccessPharmacy Full Site: One-Year Individual Subscription $595 USD Buy Now View All Subscription Options