Drug Information Journal最新文献

The future holds great promise for the Rx-to-OTC switch, if we will collectively plan and manage that process. The impact of Rx-to-OTC switches will extend far beyond the technical and regulatory issues and implications. Certainly, pharmaceutical manufacturers, the Food and Drug Administration, and the Federal Trade Commission are at the center of this issue, but no less important are the roles of physicians, pharmacists, and consumers. The social and economical, and even logistical, aspects of the switch process should be considered as antecedents to an Rx-to-OTC switch policy, rather than as consequences to be measured after such a policy has been determined. Finally, the evolution of an Rx-to-OTC switch policy in the coming months and years should avoid the path of political and administrative expediency and it should avoid the consideration of special interests in isolation from the broader social context. The development of a sound Rx-to-OTC switch policy will occur only if the direction and demand truly comes from within the ranks of the consumers.

Clinical case report forms--from both a content and format point of view--play a key role in the successful completion of a clinical trial. However, as many of us are too well aware, the design of these forms are often given less attention than they should be in the rush to get a clinical trial underway. This session will highlight the importance of well-designed case report forms and offer some suggestions on how to improve the effectiveness of these forms. The obvious and not so obvious benefits in the use of "standardized" forms will be presented and some sample "standardized" forms presently in use by Merck Sharp & Dohme Research Laboratories will be discussed. Since both the cost and timing of the formal composition and printing of these case report forms are always key management concerns, a time and cost effective solution to these concerns will be presented.

Comparative clinical studies are extensively used as a basis of support for the potential approval of treatments by the Food and Drug Administration and also for other general health policy decisions. The purpose of this paper is to review statistical principles that are relevant to the design, analysis, and interpretation of comparative clinical studies. Three general criteria are emphasized: clarity, comparability, and generalizability. These criteria are discussed in terms of their implications to such considerations as scope of patient population, sample size, randomization, and covariance analysis. Also, an extensive reference list further addressing these topics is presented.

The method used in France since 1977 for assessing adverse drug reaction (ADRs) is based on a three-stage process: assessment of three chronological criteria (challenge, dechallenge, and rechallenge); assessment of clinical and biological findings; and a combination of chronological and symptomatological assessments to obtain a 3-degree global score (1: doubtful, 2: possible, 3: probable). Bibliographical data (previously reported or unreported ADR) are assessed quite separately; thus, the method has a good sensitivity for detecting new ADRs.

An overview is presented of how drug experience reports most often fit in a product liability lawsuit. The three major areas include (a) the duty to warm; (b) the failure to report adverse reactions as required by regulations; and (c) the requirement to warn of unknown side effects. Recommendations for establishing a company program designed to prevent product liability are also given.

Integration of data processing, word processing, case report form design and production, and laser graphics in support of clinical research will be discussed. The software/hardware system supports case report form design and customized printing, study monitoring information management, investigator correspondence and other work processing, entry and preparation of study data for analysis, ad hoc review and reporting of study data, laser graphics and drafting, editing, and printing of complete clinical reports. Many portions of the system use the HP laser printer as a high speed, high quality output medium capable of electronic merging of forms, word processing output, data processing output, and graphics.

The assessment of causality in drug-event associations depends on the setting and purpose of such an assessment. Epidemiologists are primarily interested in population-based inferences about whether a given drug can cause a certain adverse drug reaction (ADR), and if so, how often it does so. Pharmaceutical industries and regulatory agencies are also concerned with population-based risks, but in addition must worry about individual cases. Clinicians are primarily interested in the individual, ie, whether a given drug did cause a certain adverse event in a particular patient. The authors describe an algorithm that provides specific, detailed criteria for ranking the probability that an observed untoward clinical manifestation was caused by a given drug. The criteria are subdivided into six axes of decision strategy with a built-in scoring system that ordinally ranks the probability of an adverse drug reaction as definite, probable, possible, or unlikely. To illustrate the use of the algorithm, the authors assess a reference case of pancreatitis occurring after administration of methyldopa.

In the normal conduct of a clinical drug trial, a considerable time lag exists between the point when drug response data are collected, usually by means of a standard written case report form completed at the time of an individual patient visit, and the time when it is entered into the computer system (and thereafter available for assessment) in the sponsor 's facility. This lag period may range from a matter of days to one or several months. Previous efforts to reduce this time span by providing electronic data entry capability within the clinical investigator's office have generally proven unsatisfactory for reasons of complexity and relative inaccuracy. A recently-developed potential solution to this entire problem will be described. It involves the provision of a microcomputer equipped with sophisticated customized data entry software that offers a means to substantially reduce this long-standing source of delays in the completion of clinical drug trials.

The Food and Drug Administration presently receives and evaluates over 40,000 case reports of adverse drug effects a year. Each report is objectively reviewed and evaluated. A causal association assessment between each drug and reaction is made. The objective causal assessments are based on four basic principles: (a) temporal eligibility, (b) dechallenge and outcome, (c) rechallenge and outcome, and (d) confounding factors. This presentation introduces the algorithm used by the FDA Division of Drug Experience and provides the basic information needed to use the FDA algorithm for making causal relationship assessments.