Design clinics

Duffal SB, Kimko HC (eds). Simulation for designing clinical trials a pharmacokinetic-pharmacodynamic modeling perspective (Drugs and the pharmaceutical sciences, Vol 127). New York Marcel Dekker, 2003... 

HULLEY s B, CUMMINGS s R (1988) Designing clinical research, Baltimore, Williams Wilkins. 

NEWMAN T B, BROWNER s w, CUMMINGS s R, HULLEY s B (1988) Designing a new study 11. Cross-sectional and case-control studies, in Hulley S B and Cummings S R, Designing Clinical Research, Baltimore, Williams Wilkins, 75-86. 

Simulation for Designing Clinical Trials A Pharmacokinetic-Pharmacodynamic Modeling Perspective, edited by Hui C. Kimko and Stephen B. Duffull... 

In conclusion, rifaximin-based eradication regimens are promising but new antimicrobial combinations (with and without proton pump inhibitors) need to be explored in well-designed clinical trials including a large cohort of H. pylori-infected patients. 

Medical laboratories have some specific needs and these are incorporated in ISO 15189 2003, Medical Laboratories - Particular Requirements for Quality and Competence [8]. The requirements of both ISO 9001 and ISO/IEC 17025 are incorporated within this Standard. It is a customized version of ISO/IEC 17025 for medical laboratories. In the UK, UKAS have designated Clinical Pathology Accreditation (UK) Ltd as the authoritative body to accredit against this Standard. 

Quality of evidence I, evidence from >1 properly randomized, controlled trial II, evidence from <1 well-designed clinical trial, without randomization from cohort or case-controlled analytic studies (preferably from >1 center) or from multiple time-series III, evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees. 

II at least 1 well-designed clinical trial, not randomized, or a cohort or case-controlled analytical study, or from multiple time series, or from dramatic results of an uncontrolled trial III opinions of respected authorities... 

Prescription drugs must have Food and Drug Administration (FDA) approval as safe and effective for their intended purposes and are tightly regulated. To gain approval, they must undergo laboratory tests and well-designed clinical trials that demonstrate safety... 

Hulley SB, et ai. Designing Clinical Research, 3rd ed., Lippincott Williams Wilkins, Philadelphia, 2007. 

Kudoh A., H. Isihara, and A. Matsuki (1998). Effects of carbamazepine on pain scores of unipolar depressed patients with chronic pain A trial of off-on-off-on design. Clinical Journal of Pain 14 61-65. 

Beydoun, A., Sackellares, J.C., and Shu, V. (1997) Safety and efficacy of divalproex sodium monotherapy in partial epilepsy a doubleblind, concentration-response design clinical trial. Depakote Monotherapy for Partial Seizures Study Group. Neurology 48 182-188. 

M. Gumbleton, W. Sneader (1994). Pharmacokinetic considerations in rational drug design. Clinical Pharmacokinetics 26 161. 

Human studies are designed to determine Does the drug work To provide an answer, pharmaceutical companies, through a series of controlled clinical trials, must, according to the FDA, collect and submit substantial evidence of effectiveness, as well as confirmation of relative safety in terms of the risk-to-benefit ratio for the disease that is to be treated. It is critical from the outset to design clinical studies that pose the right question and provide an answer to the question in the intended patient population. 

The methodology to predict the time course of drug concentration in plasma after administration is well described and well accepted as a pharmacokinetic principle. Today, pharmacokinetic principles are used routinely to estimate and manage dosing of medications for their safe and effective use. Such knowledge is useful not only in designing clinical trials for a new molecular entity, but also in day-to-day clinical practice (Box 5.1). 

For newer agents, defining the plasma level or dose-response relationship should be a priority to avoid using excessive doses for prolonged periods of time. This information may also be relevant for designing clinical trials using appropriate doses of neuroleptics for comparison trials against novel antipsychotics (i.e., parallel dose-response studies). 

Statistics is concerned with the treatment of numerical data where there is an associated uncertainty or chance. Many situations contain some element of chance, e.g. the outcome from throwing a die or the response of a patient to a drug. Even though it may be impossible to predict a particular outcome with certainty, its probability can often be quantified. Knowledge of statistical principles is essential in designing clinical trials and in the interpretation and evaluation of the results. PROBABILITY... 

---